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Hope, optimism, self-efficacy, and posttraumatic stress disorder: A meta-analytic review of the protective effects of positive expectancies.

Objective: The present meta-analysis consolidated research examining how positive expectancies (e.g., hope, self-efficacy, and optimism) may protect against the development of posttraumatic stress disorder (PTSD). Method: Articles were identified by searching PILOTS, PsycINFO, PubMed, and ProQuest Dissertations and Theses databases. Results: Aggregated results from 154 studies indicated that positive expectancies were associated with lower levels of PTSD symptoms. This relationship was stronger for coping-specific self-efficacy (k = 38, r = -.49; -.54 to -.43) and hope (k = 20, r = -.34; -.39 to -.28) compared with general self-efficacy (k = 45, r = -.25; -.30 to -.20) and optimism (k = 59, r = -.29; -.33 to -.25) when examining cross-sectional studies, and results were consistent in prospective studies. Age and gender did not moderate the cross-sectional relationships. Conclusions: These findings indicate that positive expectancies predict post-trauma resilience. Future research should identify moderators and examine positive expectancies as mechanisms of change in therapy.

Journal of clinical psychology · meta-analysis · 116 citationsread the source →

Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

Background: Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. Methods: In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Findings: Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events. Interpretation: Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults. Funding: US Department of Veterans Affairs.

The lancet. Psychiatry · randomised controlled trial · 123 citationsread the source →

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

Background: Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Method/design: Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. Discussion: This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. Trial registration: This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693 .

Trials · randomised controlled trial · 18 citationsread the source →

Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa.

Objective: There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment for adolescent bulimia nervosa (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these 2 specific therapies, FBT-BN and CBT-A. In addition, a smaller participant group was randomized to a nonspecific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment. Method: This 2-site (Chicago and Stanford) randomized controlled trial included 130 participants (aged 12-18 years) meeting DSM-IV criteria for BN or partial BN (binge eating and purging once or more per week for 6 months). Outcomes were assessed at baseline, end of treatment, and 6 and 12 months posttreatment. Treatments involved 18 outpatient sessions over 6 months. The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment, using the Eating Disorder Examination. Results: Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment (39% versus 20%; p = .040, number needed to treat [NNT] = 5) and at 6-month follow-up (44% versus 25%; p = .030, NNT = 5). Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up (49% versus 32%; p = .130, NNT = 6). Conclusion: In this study, FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up. By 12-month follow-up, there were no statistically significant differences between the 2 treatments. Clinical trial registration information: Study of Treatment for Adolescents With Bulimia Nervosa; http://clinicaltrials.gov/; NCT00879151.

Journal of the American Academy of Child and Adolescent Psychiatry · randomised controlled trial · 113 citationsread the source →

Emerging Adulthood and College‐aged Youth: An Overlooked Age for Weight‐related Behavior Change

Obesity is a major public health concern, and effective population-wide intervention strategies aimed at reducing obesity are needed. Although a growing body of literature has explored modifiable determinants of excess weight gain in adults and, to a lesser extent, in children, other important ages have been understudied. Though once considered to be an age of optimal health and well-being, the transition from adolescence to young adulthood is gaining recognition as an important time for health promotion and disease prevention. Not only is the presence of obesity and unhealthy lifestyle characteristics at this life stage associated with increased chronic disease risk, but this also may be a critical time during which young people establish independence and adopt lasting health behavior patterns. The objectives of this article are to: (i) describe emerging adulthood as a developmentally unique life stage, (ii) highlight epidemiologic evidence documenting adverse changes in diet, physical activity, and weight during this stage, (iii) discuss the influence of food and beverage marketing targeting emerging adults, and (iv) illustrate the need for health promotion and intervention efforts that could target young adults through settings such as postsecondary institutions. Over the past 50 years, major population-level demographic shifts including increases in postsecondary education and delays in marriage and childbearing have occurred. These shifts have opened the door for a period of “emerging adulthood,” typically defined as 18–25 years of age (1). This period is marked by important transitions such as leaving home and increasing autonomy in decision-making; however at the same time, adult responsibilities such as financial independence and residential and employment stability are still in flux. This period of emerging adulthood may be an important, yet overlooked, age for establishing long-term health behavior patterns. Several factors differentiate emerging adulthood from other life stages and have specific relevance to the formation of health behavior patterns, including identity development and shifting interpersonal influences. One defining characteristic of this life stage is the development of a self identity. Emerging adulthood is a time for the exploration of new ideologies and behaviors which allow individuals to express their individuality. Given previous research showing that identity (e.g., incorporating healthy lifestyle characteristics in the concept of one's self) is an important indicator of lasting health behavior change, emerging adulthood may be a particularly important time for establishing and intervening on long-term health behavior patterns (2,3). In addition, other psychosocial attributes associated with beneficial health behaviors (e.g., self-efficacy) develop or become established during this period of emerging adulthood (4), providing support for the unique importance of this life stage in long-term behavioral patterning. Emerging adulthood may also be a time for changing support systems and shifting interpersonal influences. Although the influence of parents and family is well established in the literature on childhood and, to a lesser extent, adolescent diet and physical activity patterns, little research has examined these issues among young adults. Young adults spend more leisure time alone compared to other age group (except retirees ≥55 years) (5) and are often assumed to be more disconnected from their family. However, some research suggests that closer relationships with parents (6,7) and siblings (8) may evolve as youth transition into college and adulthood (9,10). As youth become more independent, family and social network influences begin to shift and may serve different roles, as compared to that which they served in childhood and adolescence. Much additional research is needed to understand the evolving social influences in the emerging adult years and the extent to which this may influence health behavior patterns. Given the overall paucity of research in this area, more work is needed to understand better how the unique characteristics of emerging adulthood may contribute to establishing long-term behavioral patterns and the possible vulnerability of this life stage to various influences. The transition from adolescence to adulthood and the determinants of eating and physical activity is understudied. However, national trend data suggest that this is a risky period for the development of obesity, as well as unhealthy diet and physical activity practices. Weight gain. Research from national surveys and longitudinal cohorts has identified the transition between adolescence and adulthood as a period of increased risk for excess weight gain. Nationally representative cross-sectional survey data from the Behavioral Risk Factor Surveillance System indicated that from 1991 to 1998, the greatest magnitude of increase in obesity prevalence was among 18–29-year olds (increasing from 7.1 to 12.1%) (11). The prevalence of obesity among young adults more than doubled in the past 30 years. The most recent National Health and Nutrition Examination Survey (NHANES) data indicate that the prevalence has continued to increase since 1999 (ref. 12). Currently, 28.5% of 20–39-year olds are obese and 57.1% are overweight or obese (12). Nationally representative longitudinal cohort data from the National Longitudinal Study of Adolescent Health (Add Health) (13), assessing 9,795 adolescents (baseline age: 13–20 years in 1996), found that the 5-year incidence of obesity was nearly 13% (follow-up age: 19–26 years in 2001), whereas only 1.6% shifted from being obese to nonobese. In comparison to NHANES (1971–1974), the Add Health cohort showed substantial secular changes in the BMI distribution over time, particularly among individuals aged 19–26 years (13). In addition, findings from the CARDIA (Coronary Artery Risk Development in Young Adults) (14,15) longitudinal cohort illustrate both 5- and 10-year increases in weight among individuals 18–30 years of age at baseline (1985). Five-year weight gain was greater for men aged 18–24 years compared to men aged 25–30 years (14). Furthermore, the largest 10-year weight gains were seen among those in their early- to mid-twenties, as compared to those in their thirties (15). Physical activity. Although longitudinal data are limited, there is evidence of dramatic changes in lifestyle characteristics during this period. Cohort data from Add Health indicate that although most adolescents fail to meet national guidelines for physical activity (33.6%), even fewer meet these guidelines as young adults (12.7%) (16). In addition, findings from Project EAT (Eating Among Teens), a 5-year longitudinal cohort study of Minnesota adolescents, confirm such adverse changes in activity patterns during the transition from high school to young adulthood (17). Findings showed longitudinal changes in moderate to vigorous physical activity, particularly among girls (decreasing from 5.1 to 3.5 h/week aged from 16 to 20 years), and leisure time computer use, particularly among boys (increasing from 10.4 to 14.2 h/week aged from 16 to 20 years). Overall, many changes in physical activity patterns began during the transition from junior to senior high school and continued during the transition from high school to post-high school. One notable exception is moderate to vigorous physical activity among boys, which only began to decline during the transition after high school. Furthermore, a recent analysis of the National Health Interview survey data (18) indicated that age-related declines in physical activity are particularly pronounced between 15 and 18 years of age and continue through age 21. Physical activity has been shown to decline even further with specific life events typically following emerging adulthood (such as moving into a live-in relationship, getting married, and becoming a parent), but generally do not appear to continue to decline with age after mid-adulthood (30–64 years) (18). Thus health-promotion efforts to increase activity during emerging adulthood may be particularly important. Dietary intake. Research also suggests that declines in overall-diet quality may accompany these unfavorable shifts in activity patterns during the transition to adulthood (19,20). For example, fast food consumption has been associated with weight gain over time, and findings from national survey data indicate that fast food restaurant use is highest in young adulthood: 52% of 20–39 years reported eating fast food on one or both days of the Continuing Survey of Food Intakes by Individuals (1994–1996, 1998) (21). These data also indicate that soft drink intake is highest among 19–39-year olds compared to other age groups (22). In addition, NHANES data illustrate that a majority of young adults (aged 20–29 years) consume <1 serving/day of fruit (males 63%, females 59%) and vegetables (including potatoes, males 19%, females 20%) (23). Unfortunately, however, the collapsing of ages 19–39 years does not allow for an examination of the emerging adult period. Longitudinal findings from Project EAT also indicate adverse changes in dietary intake. For example, total fruit and vegetable intake decreased significantly (by >½ serving/day) during the 5-year transition period after high school (24). Add Health data indicate that fast food consumption markedly increased and consumption of breakfast decreased across a 5-year transition between adolescence and adulthood (25). The Bogalusa Heart Study (19), a longitudinal study of a biracial cohort following children >15 years into young adulthood, also showed a substantial decline in diet quality as individuals progressed through this transition. Findings indicate that individuals consumed less fruits/fruit juice and milk (19) and more sweetened beverages, salty snacks, and beef as young adults (19–28 years) than as children. Several studies have reported that despite changes in diet quality, there is substantial tracking in dietary intake between adolescence and young adulthood, as well as into later adulthood (20,26,27). Weight status also shows a high degree of tracking over time (28). Thus setting a “trajectory” for beneficial health behavior patterns and dietary intake during this time may be an important step toward initiating lasting healthy behaviors. Furthermore, a growing number of individuals are now becoming obese during adolescence and are exposed to a wide array of precursors to poor-diet quality and inactivity before the emerging adult years. For example, secular trends suggest declining rates of family meals and home food preparation (29), potentially leaving young adults without the skills to prepare foods and plan healthful meals on their own. Thus, challenges lie in reversing the effects of adverse adolescent exposures during the emerging adult years and promoting healthful long-term behavior patterns in all segments of the population. Dietary intake is influenced by a variety of factors, including individual, interpersonal, institutional, and macro-system influences. Although many of these influences are thought to be shared by a wide range of age groups, food and beverage marketing may be a particularly potent macro-level influence for emerging adults. The food, beverage and restaurant industries are estimated to have spent >$11 billion on advertising in 2004 alone (30). Young adults aged 18–24 years are a highly desirable market, particularly among fast food and soft drink companies. Marketing campaigns geared toward young adults, particularly males, have brought increased sales to fast food restaurant chains in the past decade (31,32,33,34). These campaigns have been specifically designed to increase product recognition, sales and brand loyalty among this group and have been widely promoted in young adult media markets. A number of these successful campaigns have targeted issues such as fast food late night dining and value pricing (32,35). For example, in launching its late night “Fourthmeal” campaign (with “Fourthmeal” marketed as “the meal between dinner and breakfast”), Taco Bell cites industry research in its press release indicating that nearly 50% of males aged 18–29 years are eating out after 7 pm (32). Industry research also suggests that young males spend well above market averages in these visits, averaging over $7.00 (ref. 36). To our knowledge, similar peer-reviewed evidence in the scientific literature is not available to confirm these trends. A number of these successful industry-driven campaigns have received recognition from the marketing and advertising community, for example, receiving EFFIE Awards (prestigious annual advertising awards) for their work in effectively targeting young adults. Honored campaigns include: • Hardee's. In 2001, industry research found that among its target markets Hardee's was “the most avoided restaurant in the fast food category” (31). Launching a major initiative targeting frequent fast food consumers, the company conducted “a segmentation analysis … to create a landscape from which we selected a more meaningful target for Hardee's. We called this target ‘Young Hungry Guys.’ This group is defined as young burger eaters (men 16–34) who want a more adult-like place to eat the burgers they love. This group seeks out big burgers as their food of choice, has the most growth potential for Hardee's and represent the heaviest usage in the fast food category” (31). With this, the Thickburger was introduced (providing ∼850–1,400 calories/burger). As a result, the company grew from the lowest to the highest ranked leading quick-service restaurant among young male fast food consumers (31). • Burger King. In February 2004 after significantly declining sales, Burger King refocused its efforts on its heaviest users, identified as males aged 16–34 years (34). To do so, they introduced the large-sized Angus Steak Burger. Describing its creative strategy, the marketing team states that “since the beginning of time, men have been eating large amounts of meat cooked over fires. For thousands of years, society has been wired to associate this kind of indulgence with power, pleasure and status. The problem is our culture is on an anti-indulgence craze the likes of which we have never seen before. Our strategy was to give our target permission to indulge in a great tasting burger and not apologize for it. And nothing gives them permission better than the affordable, deeply satisfying fire-grilled Angus Steak Burger…” (34). After increasing its market share among young men, this single-menu item subsequently accounted for 10% of sales dollars for Burger King. • Jack in the Box. 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Obesity · 1316 citationsread the source →

Community Health Advisors' Participation in a Dissemination and Implementation Study of an Evidence-Based Physical Activity and Healthy Eating Program in a Faith-Based Setting.

Community health advisors (CHAs) have been widely involved in health promotion, but few details on role expectations, retention, and evaluation have been reported. In a dissemination and implementation (D&I) study of an evidence-based healthy eating and physical activity program, 59 churches were randomized to an intervention (n = 39) or control (delayed intervention) (n = 20) condition. In a novel approach, CHAs worked with church committees rather than congregants by providing training (n = 59) and technical assistance (n = 54) to the committees to implement a program focused on structural and policy-level changes to support congregants' behavioral changes. CHA training comprised self-study via electronic training modules, in-person training, and telephone-based training. Evaluation methods were pilot test participants' and CHAs' ratings of their training; observers' ratings of CHAs' church training delivery; church committee members' ratings of the training experience, including CHAs' performance; and data from the TA database to assess CHAs' adherence to the protocol. The main challenge was the early dropout of one CHA and the reduced role of another. CHAs trained 142 intervention and 60 control church committee members in nine sessions; they covered 99% (intervention) and 90% (control) of training content, indicating high fidelity. Observers' scored CHAs' teaching and facilitation skills at 96.7% (intervention) and 80% (control) of the possible score. CHAs completed 92% of intervention and 93% of control TA calls. The great majority of church participants' comments regarding CHAs were positive. This study demonstrates that with training and support, CHAs demonstrate high levels of intervention fidelity, confidence, and competence.

Journal of community health · randomised controlled trial · 17 citationsread the source →

Investigating the subjective and objective efficacy of a cognitive behavioural therapy for insomnia (CBT-I)-based smartphone app on sleep: A randomised controlled trial.

Due to insufficient treatment options for insomnia, effective solutions are urgently needed. We evaluated the effects of a CBT-I-based app combining sleep training with subjective and objective sleep monitoring on (i) sleep and (ii) subjective-objective sleep discrepancies (SOSD). Fifty-seven volunteers (20-76 years; MAge = 45.67 ± 16.38; 39 female) suffering from sleep problems were randomly assigned to an experimental group (EG, n = 28) or a waitlist control group (CG, n = 29). During the 6-week app phase, the EG used the CBT-I-based programme and a heart rate sensor for daily sleep monitoring and -feedback, while the CG used sleep monitoring only. Sleep was measured (i) subjectively via questionnaires (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), (ii) objectively via ambulatory polysomnography (PSG), and (iii) continuously via heart-rate sensor and sleep diaries. Data revealed interactions for ISI (p = 0.003, ƞ2 part = 0.11) and PSQI (p = 0.050, ƞ2 part = 0.05), indicating training-specific improvements in EG, yet not in CG. While PSG-derived outcomes appear to be less training-specific, a tendential reduction in wake after sleep onset (WASO) was found in EG (p = 0.061, d = 0.55). Regarding changes in SOSD, the results indicate improvements during the app phase (EG) for sleep efficiency, sleep onset latency, and WASO (p ≤ 0.022, d ≥ 0.46); for total sleep time both groups showed a SOSD reduction. The findings indicate beneficial effects of a novel smartphone app on sleep and SOSD. More scientific evaluation of such digital programmes is needed to ultimately help in reducing the gap in non-pharmacological insomnia treatment.

Journal of sleep research · randomised controlled trial · 12 citationsread the source →

Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial.

Background: The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Objective: Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). Methods: The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Results: Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs. CG=0.5%) in chronic "trait" anxiety. A similar pattern was found for coping skills: both treatments were able to significantly increase most coping skills, but only EG participants reported a significant increase (EG=14% vs CG=0.3%) in the Emotional Support skill. Conclusions: Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment: CBT. Consequently, these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management. Trial registration: ClinicalTrials.gov: NCT01683617; http://clinicaltrials.gov/show/NCT01683617 (Archived by WebCite at http://www.webcitation.org/6QnziHv3h).

Journal of medical Internet research · randomised controlled trial · 68 citationsread the source →

A randomized controlled trial of a smartphone app for posttraumatic stress disorder symptoms.

Objective: Posttraumatic stress disorder (PTSD) is highly prevalent in the population, but relatively few affected individuals receive treatment for it. Smartphone applications (apps) could help address this unmet need by offering sound psychoeducational information and evidence-based cognitive behavioral coping tools. We conducted a randomized controlled trial to assess the efficacy of a free, publicly available smartphone app (PTSD Coach) for self-management of PTSD symptoms. Method: One hundred 20 participants who were an average of 39 years old, mostly women (69.2%) and White (66.7%), recruited primarily through online advertisements, were randomized to either a PTSD Coach (n = 62) or a waitlist condition (n = 58) for 3 months. Web-administered self-report measures of PTSD, PTSD symptom coping self-efficacy, depression, and psychosocial functioning were conducted at baseline, posttreatment, and 3 months following treatment. Results: Following the intent-to-treat principle, repeated-measures analyses of variance (ANOVAs) revealed that at posttreatment, PTSD Coach participants had significantly greater improvements in PTSD symptoms (p = .035), depression symptoms (p = .005), and psychosocial functioning (p = .007) than did waitlist participants; however, at posttreatment, there were no significant mean differences in outcomes between conditions. A greater proportion of PTSD Coach participants achieved clinically significant PTSD symptom improvement (p = .018) than waitlist participants. Conclusion: PTSD Coach use resulted in significantly greater improvements in PTSD symptoms and other outcomes relative to a waitlist condition. Given the ubiquity of smartphones, PTSD Coach may provide a wide-reaching, convenient public health intervention for individuals with PTSD symptoms who are not receiving care. (PsycINFO Database Record

Journal of consulting and clinical psychology · randomised controlled trial · 132 citationsread the source →

Blood lead levels and major depressive disorder, panic disorder, and generalized anxiety disorder in US young adults.

Context: Lead is a ubiquitous neurotoxicant, and adverse cognitive and behavioral effects are well-documented in children and occupationally exposed adults but not in adults with low environmental exposure. Objective: To investigate the association of current blood lead levels with 3 common psychiatric disorders-major depression, panic, and generalized anxiety-in young adults. Design: Cross-sectional epidemiologic survey. Setting: Nationally representative sample of US adults. Participants: A total of 1987 adults aged 20 to 39 years who responded to the National Health and Nutrition Examination Survey (1999-2004). Main outcome measures: Twelve-month DSM-IV criteria-based diagnoses of major depressive disorder, panic disorder, and generalized anxiety disorder assessed using the Composite International Diagnostic Interview. Results: The mean (SD) blood lead level was 1.61 (1.72) microg/dL (range, 0.3-37.3 microg/dL) (to convert to micromoles per liter, multiply by 0.0483). Increasing blood lead levels were associated with higher odds of major depression (P = .05 for trend) and panic disorder (P = .02 for trend) but not generalized anxiety disorder (P = .78 for trend) after adjustment for sex, age, race/ethnicity, education status, and poverty to income ratio. Persons with blood lead levels in the highest quintile had 2.3 times the odds of major depressive disorder (95% confidence interval [CI], 1.13-4.75) and 4.9 times the odds of panic disorder (1.32-18.48) as those in the lowest quintile. Cigarette smoking was associated with higher blood lead levels and outcome, but models that excluded current smokers also resulted in significantly increased odds of major depression (P = .03 for trend) and panic disorder (P = .01 for trend) with higher blood lead quintiles. Conclusions: In these young adults with low levels of lead exposure, higher blood lead levels were associated with increased odds of major depression and panic disorders. Exposure to lead at levels generally considered safe could result in adverse mental health outcomes.

Archives of general psychiatry · cohort or longitudinal · 102 citationsread the source →

Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis.

Objective: To determine long-term clinical outcomes in survivors of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) coronavirus infections after hospitalization or intensive care unit admission. Data sources: Ovid MEDLINE, EMBASE, CINAHL Plus, and PsycINFO were searched. Study selection: Original studies reporting clinical outcomes of adult SARS and MERS survivors 3 months after admission or 2 months after discharge were included. Data extraction: Studies were graded using the Oxford Centre for Evidence-Based Medicine 2009 Level of Evidence Tool. Meta-analysis was used to derive pooled estimates for prevalence/severity of outcomes up to 6 months after hospital discharge, and beyond 6 months after discharge. Data synthesis: Of 1,169 identified studies, 28 were included in the analysis. Pooled analysis revealed that common complications up to 6 months after discharge were: impaired diffusing capacity for carbon monoxide (prevalence 27%, 95% confidence interval (CI) 15–45%); and reduced exercise capacity (mean 6-min walking distance 461 m, CI 450–473 m). The prevalences of post-traumatic stress disorder (39%, 95% CI 31–47%), depression (33%, 95% CI 20–50%) and anxiety (30%, 95% CI 10–61) beyond 6 months after discharge were considerable. Low scores on Short-Form 36 were identified beyond 6 months after discharge. Conclusion: Lung function abnormalities, psychological impairment and reduced exercise capacity were common in SARS and MERS survivors. Clinicians should anticipate and investigate similar long-term outcomes in COVID-19 survivors.

Journal of rehabilitation medicine · meta-analysis · 418 citationsread the source →

Reasons for participating and genetic information needs among racially and ethnically diverse biobank participants: a focus group study.

In order for DNA biobanks to be a valuable reservoir of genetic information, large numbers of participants from all racial and ethnic backgrounds need to be recruited. This study explored reasons for participating in a new biobank among primarily Hispanic and African American individuals, as well as their general attitudes towards genetic research, and their views on obtaining genetic tests. Focus groups were conducted with Mount Sinai Biobank participants recruited from predominantly lower income, minority communities. The topic guide included questions on The Mount Sinai Biobank, genetic research, and genetic testing. All focus groups were audio recorded, transcribed, and analyzed using thematic analysis. The six focus groups comprised 43 participants: 39 females and four males, aged 27-76 years, with a median household income category of $20,000-$39,999. Twenty-one participants were Hispanic, 20 African American, one Asian, and one White. Participants' reasons for participating in the biobank included altruism, personal and family benefit, and general curiosity. Although there was evidence of conflation between genetic research and genetic testing, most participants held positive views of genetic research and expressed interest in receiving personal genetic test results. Participants wanted to learn more about genetic research and suggested various venues such as health fairs for disseminating information. Participation in biobanks by racial and ethnic minorities is apparently driven by altruism, and desire for personal or collective health benefits. Participants had generally positive attitudes, limited understanding of genetics and genetic research, and made useful suggestions regarding information dissemination mechanisms.

Journal of community genetics · 68 citationsread the source →

Interleukin-6, C-reactive protein and biochemical parameters during prolonged intermittent fasting.

Background: It is well known that nutritional habits, sleeping patterns and meal frequency have profound effects on maintaining human health. Ramadan is a religious month for Islam, during which Muslims do not eat and drink during the daylight hours. The duration of restricted food and beverage intake is approximately 12 h/day for 1 month, which makes Ramadan a model of prolonged intermittent fasting. Methods: In order to evaluate the effects of long-lasting modifications of food intake on inflammatory markers and biochemical parameters 40 healthy volunteers of normal weight [20 females aged between 20 and 38 years, 20 males aged between 23 and 39 years, body mass index (BMI) <25 kg/m(2)] who fasted during Ramadan and another 28 healthy age- and BMI-matched volunteers (14 males, 14 females) who did not fast participated in the study. Venous blood samples were taken 1 week before Ramadan, during the last week of Ramadan and 3 weeks after Ramadan. Serum interleukin-6 (IL-6), C-reactive protein (CRP), homocysteine, vitamin B(12), folate, total cholesterol (TC), triglycerides, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels were measured. Results: No significant changes were observed in serum total cholesterol, triglycerides and LDL levels. TC/HDL ratio (HDL risk factor) was decreased during and after Ramadan in both genders in the fasting group while there were no changes in the nonfasting group. IL-6 (p < 0.001), CRP (p < 0.001) and homocysteine (p < 0.01) levels were significantly low during Ramadan in the fasting subjects of both genders when compared to basal values (1 week before Ramadan). Conclusion: Our results demonstrate that prolonged intermittent fasting in a model like Ramadan has some positive effects on the inflammatory status of the body and on the risk factors for cardiovascular diseases such as homocysteine, CRP and TC/HDL ratio.

Annals of nutrition & metabolism · 122 citationsread the source →

Are interventions focused on gender-norms effective in preventing domestic violence against women in low and lower-middle income countries? A systematic review and meta-analysis.

Background: One in three women experience intimate partner violence worldwide, according to many primary studies. However, systematic review and meta-analysis of intimate partner violence is very limited. Therefore, we set to summarize the findings of existing primary studies to generate evidence for informed decisions to tackle domestic violence against women in low and lower-middle income countries. Methods: Studies were searched from main databases (Medline via PubMed, EMBASE, CINAHL, PopLine and Web of Science), Google scholar and other relevant sources using electronic and manual techniques. Published and unpublished studies written in English and conducted among women aged (15-49 years) from 1994 to 2017 were eligible. Data were extracted independently by two authors, and recorded in Microsoft Excel sheet. Heterogeneity between included studies was assessed using I2, and publication bias was explored using visual inspection of funnel plot. Statistical analysis was carried out to determine the pooled prevalence using Comprehensive Meta-Analysis software. In addition, sub-group analysis was carried out by study-setting and types of intimate partner violence. Results: Fifty two studies were included in the systematic review. Of these, 33 studies were included in the meta-analysis. The pooled prevalence of lifetime intimate partner violence was 55% (95% CI: 52, 59%). Of these, main categories were lifetime physical violence [39% (95% CI: 33, 45%); psychological violence [45% (95% CI: 40, 52%)] and sexual violence [20% (95% CI: 17, 23%)]. Furthermore, the pooled prevalence of current intimate partner violence was 38% (95% CI: 34, 43%). Of these, physical violence [25% (95% CI: 21, 28%)]; psychological violence [30% (95% CI: 24, 36%)] and sexual violence [7.0% (95% CI: 6.6, 7.5%)] were the pooled prevalence for the major types of intimate partner violence. In addition, concurrent intimate partner violence was 13% (95% CI: 12, 15%). Individual, relationship, community and societal level factors were associated with intimate partner violence. Traditional community gender-norm transformation, stakeholders' engagement, women's empowerment, intervention integration and policy/legal framework were highly recommended interventions to prevent intimate partner violence. Conclusion: Lifetime and current intimate partner violence is common and unacceptably high. Therefore, concerned bodies will need to design and implement strategies to transform traditional gender norms, engage stakeholders, empower women and integrate service to prevent violence against women. Protocol registration: PROSPERO: 2017: CRD42017079977 .

Reproductive health · meta-analysis · 43 citationsread the source →

Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.

Background: Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective. Objectives: To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults. Search methods: We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions. Selection criteria: We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments. Data collection and analysis: Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables. Main results: We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants. Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size. Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous. There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct. One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme. No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants. The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available. Authors' conclusions: There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.

The Cochrane database of systematic reviews · meta-analysis · 48 citationsread the source →

Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02).

Background: Various brain stimulation techniques are in use to treat epilepsy. These methods usually require surgical implantation procedures. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive technique to stimulate the left auricular branch of the vagus nerve at the ear conch. Objective: We performed a randomized, double-blind controlled trial (cMPsE02) to assess efficacy and safety of tVNS vs. control stimulation in patients with drug-resistant epilepsy. Methods: Primary objective was to demonstrate superiority of add-on therapy with tVNS (stimulation frequency 25 Hz, n = 39) versus active control (1 Hz, n = 37) in reducing seizure frequency over 20 weeks. Secondary objectives comprised reduction in seizure frequency from baseline to end of treatment, subgroup analyses and safety evaluation. Results: Treatment adherence was 84% in the 1 Hz group and 88% in the 25 Hz group, respectively. Stimulation intensity significantly differed between the 1 Hz group (1.02 ± 0.83 mA) and the 25 Hz group (0.50 ± 0.47 mA; p = 0.006). Mean seizure reduction per 28 days at end of treatment was -2.9% in the 1 Hz group and 23.4% in the 25 Hz group (p = 0.146). In contrast to controls, we found a significant reduction in seizure frequency in patients of the 25 Hz group who completed the full treatment period (20 weeks; n = 26, 34.2%, p = 0.034). Responder rates (25%, 50%) were similar in both groups. Subgroup analyses for seizure type and baseline seizure frequency revealed no significant differences. Adverse events were usually mild or moderate and comprised headache, ear pain, application site erythema, vertigo, fatigue, and nausea. Four serious adverse events were reported including one sudden unexplained death in epilepsy patients (SUDEP) in the 1 Hz group which was assessed as not treatment-related. Conclusions: tVNS had a high treatment adherence and was well tolerated. Superiority of 25 Hz tVNS over 1 Hz tVNS could not be proven in this relatively small study, which might be attributed to the higher stimulation intensity in the control group. Efficacy data revealed results that justify further trials with larger patient numbers and longer observation periods.

Brain stimulation · randomised controlled trial · 206 citationsread the source →

Acceptability, tolerability, and potential efficacy of cognitive behavioural therapy for Insomnia Disorder subtypes defined by polysomnography: A retrospective cohort study.

In this retrospective cohort study, we describe acceptability, tolerability and potential efficacy of cognitive behavioural therapy (CBT) in Insomnia Disorder subtypes, derived from polysomnography (PSG): insomnia with normal-sleep duration (I-NSD) and insomnia with short-sleep duration (I-SSD). All research volunteers were offered access to digital CBT, single component sleep restriction therapy and face-to-face group CBT. Follow-up occurred at three months post-treatment using the insomnia severity index (ISI). 96 participants (61 females, mean age of 41 years) were grouped into either normal-sleep (n = 53) or short-sleep (n = 43). CBT was acceptable to 63% of participants (normal-sleep = 31, short-sleep = 29), with 28 completing therapy (tolerability: normal-sleep = 11, short-sleep = 17). For potential efficacy, 39 (normal-sleep = 20, short-sleep = 19) out of 96 participants (41%) completed a follow-up ISI assessment. In this reduced sample, mean (SD) ISI scores decreased across both groups (normal-sleep: 18.0 (4.0) to 10.7 (4.6); short-sleep: 16.5 (5.5) to 11.0 (6.3); both P < 0.01). Those with normal-sleep were more likely to respond (≥6-point ISI reduction) to CBT compared to short-sleep (70%, n = 14/20 vs. 37%, n = 7/19 respectively, P = 0.038). In this cohort, 60 (63%) of participants attempted CBT and of those 28 (47%) completed therapy. Results may be comparable to clinical participants with implications for the successful translation of CBT for insomnia.

Scientific reports · 25 citationsread the source →

The mental health impacts of receiving a breast cancer diagnosis: A meta-analysis.

Background: Receiving a breast cancer diagnosis can be a turning point with negative impacts on mental health, treatment and prognosis. This meta-analysis sought to determine the nature and prevalence of clinically significant psychological distress-related symptoms in the wake of a breast cancer diagnosis. Methods: Ten databases were searched between March and August 2020. Thirty-nine quantitative studies were meta-analysed. Results: The prevalence of clinically significant symptoms was 39% for non-specific distress (n = 13), 34% for anxiety (n = 19), 31% for post-traumatic stress (n = 7) and 20% for depression (n = 25). No studies reporting breast cancer patients' well-being in our specific time frame were found. Conclusion: Mental health can be impacted in at least four domains following a diagnosis of breast cancer and such effects are commonplace. This study outlines a clear need for mitigating the impacts on mental health brought about by breast cancer diagnosis. CRD42020203990.

British journal of cancer · meta-analysis · 112 citationsread the source →

Associations between maternal psychological distress and mother-infant bonding: a systematic review and meta-analysis.

Purpose: Maternal psychological distress and mother-infant bonding problems each predict poorer offspring outcomes. They are also related to each other, yet the extensive literature reporting their association has not been meta-analysed. Methods: We searched MEDLINE, PsycINFO, CINAHL, Embase, ProQuest DTG, and OATD for English-language peer-reviewed and grey literature reporting an association between mother-infant bonding, and multiple indicators of maternal psychological distress. Results: We included 133 studies representing 118 samples; 99 samples (110,968 mothers) were eligible for meta-analysis. Results showed concurrent associations across a range of timepoints during the first year postpartum, between bonding problems and depression (r = .27 [95% CI 0.20, 0.35] to r = .47 [95% CI 0.41, 0.53]), anxiety (r = .27 [95% CI 0.24, 0.31] to r = .39 [95% CI 0.15, 0.59]), and stress (r = .46 [95% CI 0.40, 0.52]). Associations between antenatal distress and subsequent postpartum bonding problems were mostly weaker and with wider confidence intervals: depression (r = .20 [95% CI 0.14, 0.50] to r = .25 [95% CI 0.64, 0.85]), anxiety (r = .16 [95% CI 0.10, 0.22]), and stress (r = .15 [95% CI - 0.67, 0.80]). Pre-conception depression and anxiety were associated with postpartum bonding problems (r = - 0.17 [95% CI - 0.22, - 0.11]). Conclusion: Maternal psychological distress is associated with postpartum mother-infant bonding problems. Co-occurrence of psychological distress and bonding problems is common, but should not be assumed. There may be benefit in augmenting existing perinatal screening programs with well-validated mother-infant bonding measures.

Archives of women's mental health · meta-analysis · 89 citationsread the source →

Early additional food and fluids for healthy breastfed full-term infants.

Background: Health organisations recommend exclusive breastfeeding for six months. However, the addition of other fluids or foods before six months is common in many countries. Recently, research has suggested that introducing solid food at around four months of age while the baby continues to breastfeed is more protective against developing food allergies compared to exclusive breastfeeding for six months. Other studies have shown that the risks associated with non-exclusive breastfeeding are dependent on the type of additional food or fluid given. Given this background we felt it was important to update the previous version of this review to incorporate the latest findings from studies examining exclusive compared to non-exclusive breastfeeding. Objectives: To assess the benefits and harms of additional food or fluid for full-term healthy breastfeeding infants and to examine the timing and type of additional food or fluid. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2016) and reference lists of all relevant retrieved papers. Selection criteria: Randomised or quasi-randomised controlled trials in infants under six months of age comparing exclusive breastfeeding versus breastfeeding with any additional food or fluids. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. Main results: We included 11 trials (2542 randomised infants/mothers). Nine trials (2226 analysed) provided data on outcomes of interest to this review. The variation in outcome measures and time points made it difficult to pool results from trials. Data could only be combined in a meta-analysis for one primary (breastfeeding duration) and one secondary (weight change) outcome. None of the trials reported on physiological jaundice. Infant mortality was only reported in one trial. For the majority of older trials, the description of study methods was inadequate to assess the risk of bias. Most studies that we could assess showed a high risk of other biases and over half were at high risk of selection bias. Providing breastfeeding infants with artifical milk, compared to exclusive breastfeeding, did not affect rates of breastfeeding at hospital discharge (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.97 to 1.08; one trial, 100 infants; low-quality evidence). At three months, breastfeeding infants who were provided with artificial milk had higher rates of any breastfeeding compared to exclusively breastfeeding infants (RR 1.21, 95% CI 1.05 to 1.41; two trials, 137 infants; low-quality evidence). Infants who were given artifical milk in the first few days after birth before breastfeeding, had less "obvious or probable symptoms" of allergy compared to exclusively breastfeeding infants (RR 0.56, 95% CI 0.35 to 0.91; one trial, 207 infants; very low-quality evidence). No difference was found in maternal confidence when comparing non-exclusive breastfeeding infants who were provided with artificial milk with exclusive breastfeeding infants (mean difference (MD) 0.10, 95% CI -0.34 to 0.54; one study, 39 infants; low-quality evidence). Rates of breastfeeding were lower in the non-exclusive breastfeeding group compared to the exclusive breastfeeding group at four, eight, 12 (RR 0.68, 95% CI 0.53 to 0.87; one trial, 170 infants; low-quality evidence), 16 and 20 weeks. The addition of glucose water resulted in fewer episodes of hypoglycaemia (below 2.2 mmol/L) compared to the exclusive breastfeeding group, reported at 12 hours (RR 0.07, 95% CI 0.00 to 1.20; one trial, 170 infants; very low-quality evidence), but no significant difference at 24 hours (RR 1.57, 95% CI 0.27 to 9.17; one trial, 170 infants; very low-quality evidence). Weight loss was lower for infants who received additional glucose water (one trial, 170 infants) at six, 12, 24 and 48 hours of life (MD -32.50 g, 95% CI -52.09 to -12.91; low-quality evidence) compared to the exclusively breastfeeding infants but no difference between groups was observed at 72 hours of life (MD 3.00 g, 95% CI -20.83 to 26.83; very low-quality evidence). In another trial with the water and glucose water arms combined (one trial, 47 infants), we found no significant difference in weight loss between the additional fluid group and the exclusively breastfeeding group on either day three or day five (MD -1.03%, 95% CI -2.24 to 0.18; very low-quality evidence) and (MD -0.20%, 95% CI -0.86 to 0.46; very low-quality evidence).Infant mortality was reported in one trial with no deaths occurring in either group (1162 infants). The early introduction of potentially allergenic foods, compared to exclusively breastfeeding, did not reduce the risk of "food allergy" to one or more of these foods between one to three years of age (RR 0.80, 95% CI 0.51 to 1.25; 1162 children), visible eczema at 12 months stratified by visible eczema at enrolment (RR 0.86, 95% CI 0.51 to 1.44; 284 children), or food protein-induced enterocolitis syndrome reactions (RR 2.00, 95% CI 0.18 to 22.04; 1303 children) (all moderate-quality evidence). Breastfeeding infants receiving additional foods from four months showed no difference in infant weight gain (g) from 16 to 26 weeks compared to exclusive breastfeeding to six months (MD -39.48, 95% CI -128.43 to 49.48; two trials, 260 children; low-quality evidence) or weight z-scores (MD -0.01, 95% CI -0.15 to 0.13; one trial, 100 children; moderate-quality evidence). Authors' conclusions: We found no evidence of benefit to newborn infants on the duration of breastfeeding from the brief use of additional water or glucose water. The quality of the evidence on formula supplementation was insufficient to suggest a change in practice away from exclusive breastfeeding. For infants at four to six months, we found no evidence of benefit from additional foods nor any risks related to morbidity or weight change. The majority of studies showed high risk of other bias and most outcomes were based on low-quality evidence which meant that we were unable to fully assess the benefits or harms of supplementation or to determine the impact from timing and type of supplementation. We found no evidence to disagree with the current international recommendation that healthy infants exclusively breastfeed for the first six months.

The Cochrane database of systematic reviews · meta-analysis · 47 citationsread the source →

Cannabis-based medicines for chronic neuropathic pain in adults.

Background: This review is one of a series on drugs used to treat chronic neuropathic pain. Estimates of the population prevalence of chronic pain with neuropathic components range between 6% and 10%. Current pharmacological treatment options for neuropathic pain afford substantial benefit for only a few people, often with adverse effects that outweigh the benefits. There is a need to explore other treatment options, with different mechanisms of action for treatment of conditions with chronic neuropathic pain. Cannabis has been used for millennia to reduce pain. Herbal cannabis is currently strongly promoted by some patients and their advocates to treat any type of chronic pain. Objectives: To assess the efficacy, tolerability, and safety of cannabis-based medicines (herbal, plant-derived, synthetic) compared to placebo or conventional drugs for conditions with chronic neuropathic pain in adults. Search methods: In November 2017 we searched CENTRAL, MEDLINE, Embase, and two trials registries for published and ongoing trials, and examined the reference lists of reviewed articles. Selection criteria: We selected randomised, double-blind controlled trials of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment of conditions with chronic neuropathic pain in adults, with a treatment duration of at least two weeks and at least 10 participants per treatment arm. Data collection and analysis: Three review authors independently extracted data of study characteristics and outcomes of efficacy, tolerability and safety, examined issues of study quality, and assessed risk of bias. We resolved discrepancies by discussion. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 30% and 50% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardised mean differences for pain intensity, sleep problems, health-related quality of life (HRQoL), and psychological distress. For tolerability, we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawal due to adverse events and specific adverse events, nervous system disorders and psychiatric disorders. For safety, we calculated NNTH for serious adverse events. Meta-analysis was undertaken using a random-effects model. We assessed the quality of evidence using GRADE and created a 'Summary of findings' table. Main results: We included 16 studies with 1750 participants. The studies were 2 to 26 weeks long and compared an oromucosal spray with a plant-derived combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) (10 studies), a synthetic cannabinoid mimicking THC (nabilone) (two studies), inhaled herbal cannabis (two studies) and plant-derived THC (dronabinol) (two studies) against placebo (15 studies) and an analgesic (dihydrocodeine) (one study). We used the Cochrane 'Risk of bias' tool to assess study quality. We defined studies with zero to two unclear or high risks of bias judgements to be high-quality studies, with three to five unclear or high risks of bias to be moderate-quality studies, and with six to eight unclear or high risks of bias to be low-quality studies. Study quality was low in two studies, moderate in 12 studies and high in two studies. Nine studies were at high risk of bias for study size. We rated the quality of the evidence according to GRADE as very low to moderate. Primary outcomesCannabis-based medicines may increase the number of people achieving 50% or greater pain relief compared with placebo (21% versus 17%; risk difference (RD) 0.05 (95% confidence interval (CI) 0.00 to 0.09); NNTB 20 (95% CI 11 to 100); 1001 participants, eight studies, low-quality evidence). We rated the evidence for improvement in Patient Global Impression of Change (PGIC) with cannabis to be of very low quality (26% versus 21%;RD 0.09 (95% CI 0.01 to 0.17); NNTB 11 (95% CI 6 to 100); 1092 participants, six studies). More participants withdrew from the studies due to adverse events with cannabis-based medicines (10% of participants) than with placebo (5% of participants) (RD 0.04 (95% CI 0.02 to 0.07); NNTH 25 (95% CI 16 to 50); 1848 participants, 13 studies, moderate-quality evidence). We did not have enough evidence to determine if cannabis-based medicines increase the frequency of serious adverse events compared with placebo (RD 0.01 (95% CI -0.01 to 0.03); 1876 participants, 13 studies, low-quality evidence).Secondary outcomesCannabis-based medicines probably increase the number of people achieving pain relief of 30% or greater compared with placebo (39% versus 33%; RD 0.09 (95% CI 0.03 to 0.15); NNTB 11 (95% CI 7 to 33); 1586 participants, 10 studies, moderate quality evidence). Cannabis-based medicines may increase nervous system adverse events compared with placebo (61% versus 29%; RD 0.38 (95% CI 0.18 to 0.58); NNTH 3 (95% CI 2 to 6); 1304 participants, nine studies, low-quality evidence). Psychiatric disorders occurred in 17% of participants using cannabis-based medicines and in 5% using placebo (RD 0.10 (95% CI 0.06 to 0.15); NNTH 10 (95% CI 7 to 16); 1314 participants, nine studies, low-quality evidence).We found no information about long-term risks in the studies analysed. Subgroup analysesWe are uncertain whether herbal cannabis reduces mean pain intensity (very low-quality evidence). Herbal cannabis and placebo did not differ in tolerability (very low-quality evidence). Authors' conclusions: The potential benefits of cannabis-based medicine (herbal cannabis, plant-derived or synthetic THC, THC/CBD oromucosal spray) in chronic neuropathic pain might be outweighed by their potential harms. The quality of evidence for pain relief outcomes reflects the exclusion of participants with a history of substance abuse and other significant comorbidities from the studies, together with their small sample sizes.

The Cochrane database of systematic reviews · meta-analysis · 288 citationsread the source →

Emotion regulation and posttraumatic stress symptoms: a meta-analysis.

Emotion regulation (ER) has been identified as a critical factor in the development and maintenance of posttraumatic stress symptoms (PTS; Bardeen, Kumpula, & Orcutt, 2013 [Journal of Anxiety Disorders, 27, 188-196]; Marx & Sloan, 2005 [Behaviour Research and Therapy, 43, 569-583]; Nightingale & Williams, 2000 [British Journal of Clinical Psychology, 39, 243-254]). The current meta-analysis aimed to provide a thorough, quantitative examination of the associations between PTS and several aspects of ER. A search of the PsychINFO database resulted in 2557 titles, of which 57 met full inclusion criteria (the cross-sectional association between PTS symptoms and ER was reported, participants were 18 years or older, the article was written in English, and sufficient information was reported to calculate effect sizes). From the 57 studies that were included, 74 effect sizes were obtained. All studies were independently coded by two of the study authors for the following: citation, sample type, total N size (and group n's if applicable), mean age of participants, type of traumatic event, study design, PTS measure(s), ER measure(s), and effect size information. Eight random effects models were conducted: seven for individual ER strategies (e.g., rumination) and one for general emotion dysregulation. The largest effects were observed for general emotion dysregulation (r = 0.53; k = 13), rumination (r = 0.51; k = 5), thought suppression (r = 0.47; k = 13), and experiential avoidance (r = 0.40; k = 20). Medium effects were observed for expressive suppression (r = 0.29; k = 3) and worry (r = 0.28; k = 6). Significant effects were not observed for acceptance or reappraisal. Moderator analyses (sample and trauma type) were conducted for general emotion dysregulation, experiential avoidance, and thought suppression; no significant differences were observed. Findings from the current analysis suggest that several aspects of ER are associated with PTS symptoms across a variety of samples. Additionally, the current study highlights a number of limitations in the existing ER and PTS symptom literature.

Cognitive behaviour therapy · meta-analysis · 252 citationsread the source →

Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases.

Background & aims: Patients with Crohn's disease or ulcerative colitis have relatively high levels of stress and psychological dysfunction. Acceptance and commitment therapy (ACT) is a psychological intervention that comprises acceptance and mindfulness procedures, along with commitment and behavior change strategies, to increase psychological flexibility and reduce stress. We performed a randomized controlled trial to investigate the effect of ACT on stress in patients with inflammatory bowel diseases (IBD). Methods: A total of 122 patients with quiescent or stable, mildly active IBD were randomly assigned to an 8-week ACT program or treatment as usual (control group). Clinical, demographic, disease activity, and psychological data and blood and feces were collected at baseline and at 8 weeks and 3 months after the intervention (week 20). Scalp hair was collected at baseline and week 20 for measurement of steroid concentrations. The primary endpoint was change in stress symptoms, assessed with the Depression Anxiety Stress Scale. Secondary endpoints included changes in perceived stress, anxiety, depression, quality-of-life domains, disease activity, and cortisol concentration in hair. Results: Overall, 79 participants were included in the complete case intention-to-treat analysis. There were 39% and 45% reductions in stress in the treatment group from baseline to 8 and 20 weeks, respectively, compared with 8% and 11% in the control group (group × time interaction, P = .001). ACT was associated with reduced perceived stress (P = .036) and depression (P = .010), but not anxiety (P = .388), compared with control individuals. In the intention-to-treat analysis, changes in all 4 quality-of-life domains over time were similar in the ACT and control groups. In the per-protocol analysis, the overall well-being quality-of-life domain improved in the ACT group compared with the control group (P = .009). Subjective and objective disease activity measurements were similar between groups over the study period (all P values >.05). Hair cortisol concentrations correlated with stress (rs = 0.205, P = .050) and anxiety (rs = 0.208, P = .046) at baseline but did not change significantly in the ACT group over the study period compared with the control group (P = .831). Conclusion: In a randomized controlled trial of patients with IBD, an 8-week ACT therapy course improved stress and other indices of psychological health. ClinicalTrials.gov Identifier: NCT02350920.

Gastroenterology · randomised controlled trial · 116 citationsread the source →

Measurement of pregnancy-related anxiety worldwide: a systematic review.

Background: The perinatal period is often characterized by specific fear, worry, and anxiety concerning the pregnancy and its outcomes, referred to as pregnancy-related anxiety. Pregnancy-related anxiety is uniquely associated with negative maternal and child health outcomes during pregnancy, at birth, and early childhood; as such, it is increasingly studied. We examined how pregnancy-related anxiety is measured, where measures were developed and validated, and where pregnancy-related anxiety has been assessed. We will use these factors to identify potential issues in measurement of pregnancy-related anxiety and the geographic gaps in this area of research. Methods: We searched the Africa-Wide, CINAHL, MEDLINE, PsycARTICLES, PsycINFO; PubMed, Scopus, Web of Science Core Collection, SciELO Citation Index, and ERIC databases for studies published at any point up to 01 August 2020 that assessed pregnancy-related anxiety. Search terms included pregnancy-related anxiety, pregnancy-related worry, prenatal anxiety, anxiety during pregnancy, and pregnancy-specific anxiety, among others. Inclusion criteria included: empirical research, published in English, and the inclusion of any assessment of pregnancy-related anxiety in a sample of pregnant women. This review is registered on PROSPERO (CRD42020189938). Results: The search identified 2904 records; after screening, we retained 352 full-text articles for consideration, ultimately including 269 studies in the review based on the inclusion and exclusion criteria. In total, 39 measures of pregnancy-related anxiety were used in these 269 papers, with 18 used in two or more studies. Less than 20% of the included studies (n = 44) reported research conducted in low- and middle-income country contexts. With one exception, all measures of pregnancy-related anxiety used in more than one study were developed in high-income country contexts. Only 13.8% validated the measures for use with a low- or middle-income country population. Conclusions: Together, these results suggest that pregnancy-related anxiety is being assessed frequently among pregnant people and in many countries, but often using tools that were developed in a context dissimilar to the participants' context and which have not been validated for the target population. Culturally relevant measures of pregnancy-related anxiety which are developed and validated in low-income countries are urgently needed.

BMC pregnancy and childbirth · systematic review · 25 citationsread the source →

Sexual victimisation, peer victimisation, and mental health outcomes among adolescents in Burkina Faso: a prospective cohort study.

Background: Sexual victimisation and peer victimisation are pervasive and increase risk for mental illness. Longitudinal studies that compare their unique and cumulative effects are scarce and have been done predominantly in high-income countries. The aims of this study were to examine the prevalence, prospective associations, and gender differences in sexual and peer victimisation and mental health in a low-income, African setting. Methods: In this prospective cohort study, data were obtained from the 2017 ARISE Adolescent Health Study, a population-representative, two-wave, prospective study of adolescents (aged 12-20 years) from Burkina Faso. A random sample of adolescents was drawn from ten villages, selected to capture the five main ethnic groups, and from one of the seven sectors of Nouna town, Burkina Faso, at two timepoints: Nov 12 to Dec 27, 2017, and Nov 15 to Dec 20, 2018. Standardised interviews were conducted in French or a local language by trained researchers. We measured victimisation exposure as sexual victimisation, peer victimisation, and polyvictimisation, using lifetime frequency of exposure, and we measured mental health symptoms and disorders using the Kutcher Adolescent Depression Scale, the Primary Care Post-Traumatic Stress Disorder screen IV and 5, and a question on lifetime self-harm and number of incidents in the past year. We calculated prevalence of victimisation and mental health symptoms and disorders at the two timepoints, and we used lifetime victimisation at the first timepoint to predict mental health at the second timepoint using logistic and negative binomial regressions. Gender differences were examined using interaction terms. Findings: Of 2544 eligible adolescents, 1644 participated at time 1 and 1291 participated at time 2. The final sample with data at both timepoints included 1160 adolescents aged 12-20 years (mean 15·1, SE 0·2), of whom 469 (40·4%) were girls and 691 (59·6%) were boys. The majority ethnic group was Dafin (626 [39·1%]), followed by Bwaba (327 [20·5%]), Mossi (289 [16·0%]), Samo (206 [13·0%]), Peulh (166 [9·7%]), and other (30 [1·6%]). After survey weight adjustment, sexual victimisation (weighted percentages, time 1, 256 [13·8%] of 1620; time 2, 93 [7·2%] of 1264) and peer victimisation (weighted percentages, time 1, 453 [29·9%] of 1620; time 2, 272 [21·9%] of 1264) were common, whereas polyvictimisation was more rare (weighted percentages, time 1, 116 [6·6%] of 1620; time 2, 76 [5·7%] of 1264). Longitudinally, sexual victimisation was associated with probable clinical disorder (adjusted odds ratio 2·59, 95% CI 1·15-5·84), depressive symptoms (adjusted incidence rate ratio [aIRR] 1·39, 95% CI 1·12-1·72), and symptoms of post-traumatic stress disorder (aIRR 2·34, 1·31-4·16). Peer victimisation was associated with symptoms of post-traumatic stress disorder (aIRR 1·89, 1·13-3·17) and polyvictimisation was associated with depressive symptoms (aIRR 1·34, 1·01-1·77). Girls reported more sexual victimisation (weighted percentages, 130 [17·3%] of 681 vs 126 [11·4%] of 939), boys reported more peer victimisation (weighted percentages, 290 [33·1%] of 939 vs 163 [25·2%] of 681), and there was a significant interaction between lifetime victimisation and gender for probable clinical disorder (F [degrees of freedom 7, sample 376] 2·16; p=0·030). Interpretation: Sexual and peer victimisation were common in the study setting and increased risk for mental health problems. Adolescent girls who have been sexually victimised are especially at risk of mental health problems. Interventions targeting sexual and peer violence in low-income settings are needed. Funding: Alexander von Humboldt Foundation, the Wellcome Trust, Fondation Botnar, and Harvard TH Chan School of Public Health.

The lancet. Psychiatry · 9 citationsread the source →

Adjunctive Psychotherapy for Bipolar Disorder: A Systematic Review and Component Network Meta-analysis.

Importance: Several psychotherapy protocols have been evaluated as adjuncts to pharmacotherapy for patients with bipolar disorder, but little is known about their comparative effectiveness. Objective: To use systematic review and network meta-analysis to compare the association of using manualized psychotherapies and therapy components with reducing recurrences and stabilizing symptoms in patients with bipolar disorder. Data sources: Major bibliographic databases (MEDLINE, PsychInfo, and Cochrane Library of Systematic Reviews) and trial registries were searched from inception to June 1, 2019, for randomized clinical trials of psychotherapy for bipolar disorder. Study selection: Of 3255 abstracts, 39 randomized clinical trials were identified that compared pharmacotherapy plus manualized psychotherapy (cognitive behavioral therapy, family or conjoint therapy, interpersonal therapy, or psychoeducational therapy) with pharmacotherapy plus a control intervention (eg, supportive therapy or treatment as usual) for patients with bipolar disorder. Data extraction and synthesis: Binary outcomes (recurrence and study retention) were compared across treatments using odds ratios (ORs). For depression or mania severity scores, data were pooled and compared across treatments using standardized mean differences (SMDs) (Hedges-adjusted g using weighted pooled SDs). In component network meta-analyses, the incremental effectiveness of 13 specific therapy components was examined. Main outcomes and measures: The primary outcome was illness recurrence. Secondary outcomes were depressive and manic symptoms at 12 months and acceptability of treatment (study retention). Results: A total of 39 randomized clinical trials with 3863 participants (2247 of 3693 [60.8%] with data on sex were female; mean [SD] age, 36.5 [8.2] years) were identified. Across 20 two-group trials that provided usable information, manualized treatments were associated with lower recurrence rates than control treatments (OR, 0.56; 95% CI, 0.43-0.74). Psychoeducation with guided practice of illness management skills in a family or group format was associated with reducing recurrences vs the same strategies in an individual format (OR, 0.12; 95% CI, 0.02-0.94). Cognitive behavioral therapy (SMD, -0.32; 95% CI, -0.64 to -0.01) and, with less certainty, family or conjoint therapy (SMD, -0.46; 95% CI, -1.01 to 0.08) and interpersonal therapy (SMD, -0.46; 95% CI, -1.07 to 0.15) were associated with stabilizing depressive symptoms compared with treatment as usual. Higher study retention was associated with family or conjoint therapy (OR, 0.46; 95% CI, 0.26-0.82) and brief psychoeducation (OR, 0.44; 95% CI, 0.23-0.85) compared with standard psychoeducation. Conclusions and relevance: This study suggests that outpatients with bipolar disorder may benefit from skills-based psychosocial interventions combined with pharmacotherapy. Conclusions are tempered by heterogeneity in populations, treatment duration, and follow-up.

JAMA psychiatry · systematic review · 148 citationsread the source →

Psychosocial and psychological interventions for relapse prevention in schizophrenia: a systematic review and network meta-analysis.

Background: Many psychosocial and psychological interventions are used in patients with schizophrenia, but their comparative efficacy in the prevention of relapse is not known. We aimed to evaluate the efficacy, acceptability, and tolerability of psychosocial and psychological interventions for relapse prevention in schizophrenia. Methods: To conduct this systematic review and network meta-analysis we searched for published and unpublished randomised controlled trials that investigated psychosocial or psychological interventions aimed at preventing relapse in patients with schizophrenia. We searched EMBASE, MEDLINE, PsycINFO, BIOSIS, Cochrane Library, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov up to Jan 20, 2020, and searched PubMed up to April 14, 2020. We included open and masked studies done in adults with schizophrenia or related disorders. We excluded studies in which all patients were acutely ill, had a concomitant medical or psychiatric disorder, or were prodromal or "at risk of psychosis". Study selection and data extraction were done by two reviewers independently based on published and unpublished reports, and by contacting study authors. Data were extracted about efficacy, tolerability, and acceptability of the interventions; potential effect moderators; and study quality and characteristics. The primary outcome was relapse measured with operationalised criteria or psychiatric hospital admissions. We did random-effects network meta-analysis to calculate odds ratios (ORs) or standardised mean differences (SMDs) with 95% CIs. The study protocol was registered with PROSPERO, CRD42019147884. Findings: We identified 27 765 studies through the database search and 330 through references of previous reviews and studies. We screened 28 000 records after duplicates were removed. 24 406 records were excluded by title and abstract screening and 3594 full-text articles were assessed for eligibility. 3350 articles were then excluded for a variety of reasons, and 244 full-text articles corresponding to 85 studies were included in the qualitative synthesis. Of these, 72 studies with 10 364 participants (3939 females and 5716 males with sex indicated) were included in the network meta-analysis. The randomised controlled trials included compared 20 psychological interventions given mainly as add-on to antipsychotics. Ethnicity data were not available. Family interventions (OR 0·35, 95% CI 0·24-0·52), relapse prevention programmes (OR 0·33, 0·14-0·79), cognitive behavioural therapy (OR 0·45, 0·27-0·75), family psychoeducation (OR 0·56, 0·39-0·82), integrated interventions (OR 0·62, 0·44-0·87), and patient psychoeducation (OR 0·63, 0·42-0·94) reduced relapse more than treatment as usual at 1 year. The confidence in the estimates ranged from moderate to very low. We found no indication of publication bias. Interpretation: We found robust benefits in reducing the risk of relapse for family interventions, family psychoeducation, and cognitive behavioral therapy. These treatments should be the first psychosocial interventions to be considered in the long-term treatment for patients with schizophrenia. Funding: German Ministry for Education and Research.

The lancet. Psychiatry · systematic review · 149 citationsread the source →

Interventions for visual field defects in people with stroke.

Background: Visual field defects are estimated to affect 20% to 57% of people who have had a stroke. Visual field defects can affect functional ability in activities of daily living (commonly affecting mobility, reading and driving), quality of life, ability to participate in rehabilitation, and depression and anxiety following stroke. There are many interventions for visual field defects, which are proposed to work by restoring the visual field (restitution); compensating for the visual field defect by changing behaviour or activity (compensation); substituting for the visual field defect by using a device or extraneous modification (substitution); or ensuring appropriate diagnosis, referral and treatment prescription through standardised assessment or screening, or both. Objectives: To determine the effects of interventions for people with visual field defects after stroke. Search methods: We searched the Cochrane Stroke Group Trials Register, the Cochrane Eyes and Vision Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, AMED, PsycINFO, and PDQT Databse, and clinical trials databases, including ClinicalTrials.gov and WHO Clinical Trials Registry, to May 2018. We also searched reference lists and trials registers, handsearched journals and conference proceedings, and contacted experts. Selection criteria: Randomised trials in adults after stroke, where the intervention was specifically targeted at improving the visual field defect or improving the ability of the participant to cope with the visual field loss. The primary outcome was functional ability in activities of daily living and secondary outcomes included functional ability in extended activities of daily living, reading ability, visual field measures, balance, falls, depression and anxiety, discharge destination or residence after stroke, quality of life and social isolation, visual scanning, adverse events, and death. Data collection and analysis: Two review authors independently screened abstracts, extracted data and appraised trials. We undertook an assessment of methodological quality for allocation concealment, blinding of outcome assessors, method of dealing with missing data, and other potential sources of bias. We assessed the quality of evidence for each outcome using the GRADE approach. Main results: Twenty studies (732 randomised participants, with data for 547 participants with stroke) met the inclusion criteria for this review. However, only 10 of these studies compared the effect of an intervention with a placebo, control, or no treatment group, and eight had data which could be included in meta-analyses. Only two of these eight studies presented data relating to our primary outcome of functional abilities in activities of daily living. One study reported evidence relating to adverse events. Three studies (88 participants) compared a restitutive intervention with a control, but data were only available for one study (19 participants). There was very low-quality evidence that visual restitution therapy had no effect on visual field outcomes, and a statistically significant effect on quality of life, but limitations with these data mean that there is insufficient evidence to draw any conclusions about the effectiveness of restitutive interventions as compared to control. Four studies (193 participants) compared the effect of scanning (compensatory) training with a control or placebo intervention. There was low-quality evidence that scanning training was more beneficial than control or placebo on quality of life, measured using the Visual Function Questionnaire (VFQ-25) (two studies, 96 participants, mean difference (MD) 9.36, 95% confidence interval (CI) 3.10 to 15.62). However, there was low or very-low quality evidence of no effect on measures of visual field, extended activities of daily living, reading, and scanning ability. There was low-quality evidence of no significant increase in adverse events in people doing scanning training, as compared to no treatment. Three studies (166 participants) compared a substitutive intervention (a type of prism) with a control. There was low or very-low quality evidence that prisms did not have an effect on measures of activities of daily living, extended activities of daily living, reading, falls, or quality of life, and very low-quality evidence that they may have an effect on scanning ability (one study, 39 participants, MD 9.80, 95% CI 1.91 to 17.69). There was low-quality evidence of an increased odds of an adverse event (primarily headache) in people wearing prisms, as compared to no treatment. One study (39 participants) compared the effect of assessment by an orthoptist to standard care (no assessment) and found very low-quality evidence that there was no effect on measures of activities of daily living. Due to the quality and quantity of evidence, we remain uncertain about the benefits of assessment interventions. Authors' conclusions: There is a lack of evidence relating to the effect of interventions on our primary outcome of functional ability in activities of daily living. There is limited low-quality evidence that compensatory scanning training may be more beneficial than placebo or control at improving quality of life, but not other outcomes. There is insufficient evidence to reach any generalised conclusions about the effect of restitutive interventions or substitutive interventions (prisms) as compared to placebo, control, or no treatment. There is low-quality evidence that prisms may cause minor adverse events.

The Cochrane database of systematic reviews · systematic review · 72 citationsread the source →

Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review.

Importance: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes. Objective: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system. Evidence review: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015). Results: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10). Conclusions: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

Journal of palliative medicine · systematic review · 135 citationsread the source →

Canadian Cardiovascular Society 2022 Guidelines for Peripheral Arterial Disease.

Patients with widespread atherosclerosis such as peripheral artery disease (PAD) have a high risk of cardiovascular and limb symptoms and complications, which affects their quality of life and longevity. Over the past 2 decades there have been substantial advances in diagnostics, pharmacotherapy, and interventions including endovascular and open surgical to aid in the management of PAD patients. To summarize the evidence regarding approaches to diagnosis, risk stratification, medical and intervention treatments for patients with PAD, guided by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework, evidence was synthesized, and assessed for quality, and recommendations provided-categorized as weak or strong for each prespecified research question. Fifty-six recommendations were made, with 27% (15/56) graded as strong recommendations with high-quality evidence, 14% (8/56) were designated as strong recommendations with moderate-quality evidence, and 20% (11/56) were strong recommendations with low quality of evidence. Conversely 39% (22/56) were classified as weak recommendations. For PAD patients, strong recommendations on the basis of high-quality evidence, include smoking cessation interventions, structured exercise programs for claudication, lipid-modifying therapy, antithrombotic therapy with a single antiplatelet agent or dual pathway inhibition with low-dose rivaroxaban and aspirin; treatment of hypertension with an angiotensin converting enzyme or angiotensin receptor blocker; and for those with diabetes, a sodium-glucose cotransporter 2 inhibitor should be considered. Furthermore, autogenous grafts are more effective than prosthetic grafts for surgical bypasses for claudication or chronic limb-threatening ischemia involving the popliteal or distal arteries. Other recommendations indicated that new endovascular techniques and hybrid procedures be considered in patients with favourable anatomy and patient factors, and finally, the evidence for perioperative risk stratification for PAD patients who undergo surgery remains weak.

The Canadian journal of cardiology · guideline · 98 citationsread the source →

Neuroanatomical correlates of suicide in psychosis: the possible role of von Economo neurons.

Suicide is the most important incident in psychiatric disorders. Psychological pain and empathy to pain involves a neural network that involves the anterior cingulate cortex (ACC) and the anterior insula (AI). At the neuronal level, little is known about how complex emotions such as shame, guilt, self-derogation and social isolation, all of which feature suicidal behavior, are represented in the brain. Based on the observation that the ACC and the AI contain a large spindle-shaped cell type, referred to as von Economo neuron (VEN), which has dramatically increased in density during human evolution, and on growing evidence that VENs play a role in the pathophysiology of various neuropsychiatric disorders, including autism, psychosis and dementia, we examined the density of VENs in the ACC of suicide victims. The density of VENs was determined using cresyl violet-stained sections of the ACC of 39 individuals with psychosis (20 cases with schizophrenia, 19 with bipolar disorder). Nine subjects had died from suicide. Twenty specimen were available from the right, 19 from the left ACC. The density of VENs was significantly greater in the ACC of suicide victims with psychotic disorders compared with psychotic individuals who died from other causes. This effect was restricted to the right ACC. VEN density in the ACC seems to be increased in suicide victims with psychosis. This finding may support the assumption that VEN have a special role in emotion processing and self-evaluation, including negative self-appraisal.

PloS one · 44 citationsread the source →

Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial.

Background: Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called "Health Scouts" to promote engagement in HIV treatment and prevention services. Methods and findings: The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (<400 copies/mL). Secondary outcomes included HIV testing coverage, HIV incidence, and consistent condom use. The primary intent-to-treat analysis used log-linear binomial regression with generalized estimating equation to estimate prevalence risk ratios (PRR) in the intervention versus control arm. A total of 2,533 (45% female, mean age: 31 years) and 1,903 (46% female; mean age 32 years) residents completed the mid-study and end-study surveys, respectively. At mid-study, there were no differences in outcomes between arms. At end-study, self-reported receipt of the Health Scouts intervention was 38% in the intervention arm and 23% in the control arm, suggesting moderate intervention uptake in the intervention arm and substantial contamination in the control arm. At end-study, intention-to-treat analysis found higher HIV care coverage (PRR: 1.06, 95% CI: 1.01 to 1.10, p = 0.011) and ART coverage (PRR: 1.05, 95% CI: 1.01 to 1.10, p = 0.028) among HIV-positive participants in the intervention compared with the control arm. Male circumcision coverage among all men (PRR: 1.05, 95% CI: 0.96 to 1.14, p = 0.31) and HIV viral suppression among HIV-positive participants (PRR: 1.04, 95% CI: 0.98 to 1.12, p = 0.20) were higher in the intervention arm, but differences were not statistically significant. No differences were seen in secondary outcomes. Study limitations include reliance on self-report for programmatic outcomes and substantial contamination which may have diluted estimates of effect. Conclusions: A novel community health worker intervention improved HIV care and ART coverage in an HIV hyperendemic setting but did not clearly improve male circumcision coverage or HIV viral suppression. This community-based, implementation strategy may be a useful component in some settings for HIV epidemic control. Trial registration: ClinicalTrials.gov NCT02556957.

PLoS medicine · randomised controlled trial · 20 citationsread the source →

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. Funding: National Institute for Health Research Health Technology Assessment Programme.

The lancet. Psychiatry · randomised controlled trial · 134 citationsread the source →

3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.

Background: Post-traumatic stress disorder (PTSD) is prevalent in military personnel and first responders, many of whom do not respond to currently available treatments. This study aimed to assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treating chronic PTSD in this population. Methods: We did a randomised, double-blind, dose-response, phase 2 trial at an outpatient psychiatric clinic in the USA. We included service personnel who were 18 years or older, with chronic PTSD duration of 6 months or more, and who had a Clinician-Administered PTSD Scale (CAPS-IV) total score of 50 or greater. Using a web-based randomisation system, we randomly assigned participants (1:1:2) to three different dose groups of MDMA plus psychotherapy: 30 mg (active control), 75 mg, or 125 mg. We masked investigators, independent outcome raters, and participants until after the primary endpoint. MDMA was administered orally in two 8-h sessions with concomitant manualised psychotherapy. The primary outcome was mean change in CAPS-IV total score from baseline to 1 month after the second experimental session. Participants in the 30 mg and 75 mg groups subsequently underwent three 100-125 mg MDMA-assisted psychotherapy sessions in an open-label crossover, and all participants were assessed 12 months after the last MDMA session. Safety was monitored through adverse events, spontaneously reported expected reactions, vital signs, and suicidal ideation and behaviour. This study is registered with ClinicalTrials.gov, number NCT01211405. Findings: Between Nov 10, 2010, and Jan 29, 2015, 26 veterans and first responders met eligibility criteria and were randomly assigned to receive 30 mg (n=7), 75 mg (n=7), or 125 mg (n=12) of MDMA plus psychotherapy. At the primary endpoint, the 75 mg and 125 mg groups had significantly greater decreases in PTSD symptom severity (mean change CAPS-IV total scores of -58·3 [SD 9·8] and -44·3 [28·7]; p=0·001) than the 30 mg group (-11·4 [12·7]). Compared with the 30 mg group, Cohen's d effect sizes were large: 2·8 (95% CI 1·19-4·39) for the 75 mg group and 1·1 (0·04-2·08) for the 125 mg group. In the open-label crossover with full-dose MDMA (100-125 mg), PTSD symptom severity significantly decreased in the group that had previously received 30 mg (p=0·01), whereas no further significant decreases were observed in the group that previously achieved a large response after 75 mg doses in the blinded segment (p=0·81). PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV total score of 38·8 [SD 28·1] vs 87·1 [16·1]; p<0·0001). 85 adverse events were reported by 20 participants. Of these adverse events, four (5%) were serious: three were deemed unrelated and one possibly related to study drug treatment. Interpretation: Active doses (75 mg and 125 mg) of MDMA with adjunctive psychotherapy in a controlled setting were effective and well tolerated in reducing PTSD symptoms in veterans and first responders. Funding: Multidisciplinary Association for Psychedelic Studies.

The lancet. Psychiatry · randomised controlled trial · 258 citationsread the source →

Circumcision versus preputioplasty for balanitis xerotica obliterans: a randomised controlled feasibility trial.

Objectives: To determine: (i) feasibility for a randomised controlled trial (RCT) comparing circumcision to preputioplasty and intralesional triamcinolone (PIT) to treat balanitis xerotica obliterans (BXO) and (ii) patient outcomes to inform future study design. Patients and methods: Approval was obtained from the UK Health Research Authority and local Research Ethics Committee (Reference 16/NW/0364) and the trial protocol registered with ClinicalTrials.gov (NCT02854995). A total of 20 boys (aged 2-16 years) with BXO were randomised to either circumcision or PIT (online parallel group 1:1 allocation, non-blinded). Exclusion criteria were: (i) previous penile surgery and (ii) contraindication for either treatment. Follow-up (including satisfaction questionnaire) was at 6 weeks, 3 and 12 months. Data are presented as median (interquartile range [IQR]), continuous variables were compared by t-test. Results: A total of 54 boys were approached over 18 months: 23 (45%) were recruited and randomised. The commonest reason for non-entry was treatment preference: 12 preferred circumcision, 18 preferred PIT. Four patients withdrew after randomisation, three did not want circumcision and one did not want PIT. The groups were similar in terms of age (median [IQR] 11 [6-12] vs 8 [7-10] years, P = 0.53) and duration of symptoms (median [IQR] 6 [6-15] vs 6 [2-24] months, P = 0.77). There were no protocol breaches, serious adverse events or postoperative meatal stenosis. There was one self-resolving haematoma after PIT and one suture granuloma after circumcision. Two boys went on to have a circumcision after PIT. Overall, satisfaction levels were high for both groups. Conclusion: A definitive RCT of circumcision vs PIT for BXO appears feasible, with 39% of those approached completing the trial. More families preferred PIT. A robust comparison in the form of a multicentred RCT is required.

BJU international · randomised controlled trial · 5 citationsread the source →

Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial.

Background: Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, shows a remarkable ability to lower blood glucose, enabling many patients with long-standing type 2 diabetes to achieve normoglycaemia. We aimed to understand the physiological mechanisms underlying the action of tirzepatide in type 2 diabetes. Methods: This multicentre, randomised, double-blind, parallel-arm, phase 1 study was done at two centres in Germany. Eligible patients were aged 20-74 years, had type 2 diabetes for at least 6 months, and were being treated with lifestyle advice and stable doses of metformin, with or without one additional stable dose of another oral antihyperglycaemic medicine, 3 months before study entry. Via a randomisation table, patients were randomly assigned (3:3:2) to subcutaneously receive either tirzepatide 15 mg, semaglutide 1 mg, or placebo once per week. Endpoint measurements were done at baseline and the last week of therapy (week 28). The primary endpoint was the effect of tirzepatide versus placebo on the change in clamp disposition index (combining measures of insulin secretion and sensitivity) from baseline to week 28 of treatment and was analysed in the pharmacodynamic analysis set, which comprised all randomly assigned participants who received at least one dose of a study drug and had evaluable pharmacodynamic data. Safety was analysed in the safety population, which comprised all randomly assigned participants who received at least one dose of a study drug. Secondary endpoints included the effect of tirzepatide versus semaglutide on the change in clamp disposition index from baseline to week 28 of treatment, glucose control, total insulin secretion rate, M value (insulin sensitivity), and fasting and postprandial glucagon concentrations. Exploratory endpoints included the change in fasting and postprandial insulin concentrations. This study is registered with ClinicalTrials.gov, NCT03951753, and is complete. Findings: Between June 28, 2019, and April 8, 2021, we screened 184 individuals and enrolled 117 participants, all of whom were included in the safety population (45 in the tirzepatide 15 mg group, 44 in the semaglutide 1 mg group, and 28 in the placebo group). Because of discontinuations and exclusions due to missing or unevaluable data, 39 patients in each treatment group and 24 patients in the placebo group comprised the pharmacodynamic analysis set. With tirzepatide, the clamp disposition index increased from a least squares mean of 0·3 pmol m-2 L min-2 kg-1 (SE 0·03) at baseline by 1·9 pmol m-2 L min-2 kg-1 (0·16) to total 2·3 pmol m-2 L min-2 kg-1 (SE 0·16) at week 28 and, with placebo, the clamp disposition index did not change much from baseline (least squares mean at baseline 0·4 pmol m-2 L min-2 kg-1 [SE 0·04]; change from baseline 0·0 pmol m-2 L min-2 kg-1 [0·03]; least squares mean at week 28 0·3 [SE 0·03]; estimated treatment difference [ETD] tirzepatide vs placebo 1·92 [95% CI 1·59-2·24]; p<0·0001). The improvement with tirzepatide in clamp disposition index was significantly greater than with semaglutide (ETD 0·84 pmol m-2 L min-2 kg-1 [95% CI 0·46-1·21]). This result reflected significant improvements in total insulin secretion rate (ETD 102·09 pmol min-1 m-2 [51·84-152·33]) and insulin sensitivity (ETD 1·52 mg min-1 kg-1 [0·53-2·52]) for tirzepatide versus semaglutide. On meal tolerance testing, tirzepatide significantly reduced glucose excursions (lower insulin and glucagon concentrations) compared with placebo, with effects on these variables being greater than with semaglutide. The safety profiles of tirzepatide and semaglutide were similar, with gastrointestinal adverse events being the most common (11 [24%], 13 [30%], and seven [25%] with nausea; nine [20%], 13 [30%], and six [21%] with diarrhoea; and three [7%], five [11%], and one [4%] with vomiting, for tirzepatide, semaglutide, and placebo, respectively). There were no deaths. Interpretation: The glycaemic efficacy of GIP/GLP-1 receptor agonist tirzepatide in type 2 diabetes results from concurrent improvements in key components of diabetes pathophysiology, namely β-cell function, insulin sensitivity, and glucagon secretion. These effects were large and help to explain the remarkable glucose-lowering ability of tirzepatide seen in phase 3 studies. Funding: Eli Lilly.

The lancet. Diabetes & endocrinology · randomised controlled trial · 202 citationsread the source →

Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.

Background: Neurokinin 3 receptor antagonists are potential non-hormonal therapies for the treatment of vasomotor symptoms in menopausal women as options are scarce for those who cannot or do not want to take hormone therapy. Fezolinetant is one of the first non-hormonal neurokinin 3 receptor antagonists in development for the treatment of vasomotor symptoms due to menopause. This study investigated the safety and efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Methods: SKYLIGHT 1 is a randomised, double-blind, placebo-controlled, 12-week, phase 3 trial with a 40-week active treatment extension. This trial was done at 97 facilities across the USA, Canada, Czech Republic, Hungary, Poland, Spain, and the UK. Women aged 40-65 years with an average of seven or more moderate-to-severe hot flashes per day were randomly assigned (1:1:1) to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Randomisation was done using a web-based interactive response system and investigators, project team members, clinical staff, and participants were masked to treatment assignment. Coprimary endpoints were mean change in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12. The efficacy and safety analyses comprised all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT04003155) and is completed. Findings: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant 30 mg, and 176 to fezolinetant 45 mg (175 in the placebo group, 174 in the fezolinetant 30 mg group, and 173 in the fezolinetant 45 mg received at least one dose [safety analysis set]). One participant randomly assigned to fezolinetant 45 mg received fezolinetant 30 mg in error, so the efficacy analysis set (full analysis set) consisted of 173 in the fezolinetant 30 mg group and 174 in the fezolinetant 45 mg group. 23 participants in the placebo group, 31 in the fezolinetant 30 mg group, and 13 in the fezolinetant 45 mg group discontinued treatment before week 12, mostly due to adverse events or participant withdrawal. Compared with placebo, fezolinetant 30 mg and fezolinetant 45 mg significantly reduced the frequency of vasomotor symptoms at week 4 (difference in change in least squares mean -1·87 [SE 0·42; p<0·001], -2·07 [SE 0·42; p<0·001]) and week 12 (-2·39 [SE 0·44; p<0·001], -2·55 [SE 0·43; p<0·001]). Compared with placebo, fezolinetant 30 mg and 45 mg significantly reduced the severity of vasomotor symptoms at week 4 (-0·15 [0·06; p=0·012], -0·19 [0·06; p=0·002]) and week 12 (-0·24 [0·08; p=0·002], -0·20 [0·08; p=0·007]). Improvements in frequency and severity of vasomotor symptoms were observed after 1 week and maintained over 52 weeks. During the first 12 weeks, treatment-emergent adverse events occurred in 65 (37%) of 174 women in the fezolinetant 30 mg group, 75 (43%) of 173 in the fezolinetant 45 mg group, and 78 (45%) of 175 in the placebo group. The incidence of liver enzyme elevations was low (placebo n=1; fezolinetant 30 mg n=2; fezolinetant 45 mg n=0) and these events were generally asymptomatic, transient, and resolved while on treatment or after treatment discontinuation. Interpretation: Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. Further characterisation of the benefit of fezolinetant on quality of life, including on symptoms of mood and sexual wellbeing, merits investigation. Funding: Astellas Pharma.

Lancet (London, England) · randomised controlled trial · 172 citationsread the source →

Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial.

Background: Previous research suggests that the use of outcome feedback technology can enable psychological therapists to identify and resolve obstacles to clinical improvement. We aimed to assess the effectiveness of an outcome feedback quality assurance system applied in stepped care psychological services. Methods: This multisite, open-label, cluster randomised controlled trial was done at eight National Health Service (NHS) Trusts in England, involving therapists who were qualified to deliver evidence-based low-intensity or high-intensity psychological interventions. Adult patients (18 years or older) who accessed individual therapy with participating therapists were eligible for inclusion, except patients who accessed group therapies and those who attended less than two individual therapy sessions. Therapists were randomly assigned (1:1) to an outcome feedback intervention group or a treatment-as-usual control group by use of a computer-generated randomisation algorithm. The allocation of patients to therapists was quasi-random, whereby patients on waiting lists were allocated sequentially on the basis of therapist availability. All patients received low-intensity (less than eight sessions) or high-intensity (up to 20 sessions) psychological therapies for the duration of the 1-year study period. An automated computer algorithm alerted therapists in the outcome feedback group to patients who were not on track, and primed them to review these patients in clinical supervision. The primary outcome was symptom severity on validated depression (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalised Anxiety Disorder-7 [GAD-7]) measures after treatment of varying durations, which were compared between groups with multilevel modelling, controlling for cluster (therapist) effects. We used an intention-to-treat approach. This trial was prospectively registered with ISRCTN, number ISRCTN12459454. Findings: In total, 79 therapists were recruited to the study between Jan 8, 2016, and July 15, 2016, but two did not participate. Of these participants, 39 (51%) were randomly assigned to the outcome feedback group and 38 (49%) to the control group. Overall, 2233 patients were included in the trial (1176 [53%] were treated by therapists in the outcome feedback group, and 1057 [47%] by therapists in the control group). Patients classified as not on track had less severe symptoms after treatment if they were allocated to the outcome feedback group than those in the control group (PHQ-9 d=0·23, B=-1·03 [95% CI -1·84 to -0·23], p=0·012; GAD-7 d=0·19, B=-0·85 [-1·56 to -0·14], p=0·019). Interpretation: Supplementing psychological therapy with low-cost feedback technology can reduce symptom severity in patients at risk of poor response to treatment. This evidence supports the implementation of outcome feedback in stepped care psychological services. Funding: English NHS and Department of Health Sciences, University of York, York, UK.

The lancet. Psychiatry · randomised controlled trial · 86 citationsread the source →

Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden.

Background: Severe obesity in adolescents has a profound impact on current and future health. Metabolic and bariatric surgery (MBS) is increasingly used in adolescents internationally. However, to our knowledge, there are no randomised trials examining the currently most used surgical techniques. Our aim was to evaluate changes in BMI and secondary health and safety outcomes after MBS. Methods: The Adolescent Morbid Obesity Surgery 2 (AMOS2) study is a randomised, open-label, multicentre trial done at three university hospitals in Sweden (located in Stockholm, Gothenburg, and Malmö). Adolescents aged 13-16 years with a BMI of at least 35 kg/m2, who had attended treatment for obesity for at least 1 year, passed assessments from a paediatric psychologist and a paediatrician, and had a Tanner pubertal stage of at least 3, were randomly assigned (1:1) to MBS or intensive non-surgical treatment. Exclusion criteria included monogenic or syndromic obesity, major psychiatric illness, and regular self-induced vomiting. Computerised randomisation was stratified for sex and recruitment site. Allocation was concealed for both staff and participants until the end of the inclusion day, and then all participants were unmasked to treatment intervention. One group underwent MBS (primarily gastric bypass), while the other group received intensive non-surgical treatment starting with 8 weeks of low-calorie diet. The primary outcome was 2-year change in BMI, analysed as intention-to-treat. The trial is registered at ClinicalTrials.gov, NCT02378259. Findings: 500 people were assessed for eligibility between Aug 27, 2014, and June 7, 2017. 450 participants were excluded (397 did not meet inclusion criteria, 39 declined to participate, and 14 were excluded for various other reasons). Of the 50 remaining participants, 25 (19 females and six males) were randomly assigned to receive MBS and 25 (18 females and seven males) were assigned to intensive non-surgical treatment. Three participants (6%; one in the MBS group and two in the intensive non-surgical treatment group) did not participate in the 2-year follow-up, and in total 47 (94%) participants were assessed for the primary endpoint. Mean age of participants was 15·8 years (SD 0·9) and mean BMI at baseline was 42·6 kg/m2 (SD 5·2). After 2 years, BMI change was -12·6 kg/m2 (-35·9 kg; n=24) among adolescents undergoing MBS (Roux-en-Y gastric bypass [n=23], sleeve gastrectomy [n=2]) and -0·2 kg/m2 (0·4 kg; [n=23]) among participants in the intensive non-surgical treatment group (mean difference -12·4 kg/m2 [95% CI -15·5 to -9·3]; p<0·0001). Five (20%) patients in the intensive non-surgical group crossed over to MBS during the second year. Adverse events (n=4) after MBS were mild but included one cholecystectomy. Regarding safety outcomes, surgical patients had a reduction in bone mineral density, while controls were unchanged after 2 years (z-score change mean difference -0·9 [95% CI -1·2 to -0·6]). There were no significant differences between the groups in vitamin and mineral levels, gastrointestinal symptoms (except less reflux in the surgical group), or in mental health at the 2-year follow-up. Interpretation: MBS is an effective and well tolerated treatment for adolescents with severe obesity resulting in substantial weight loss and improvements in several aspects of metabolic health and physical quality of life over 2 years, and should be considered in adolescents with severe obesity. Funding: Sweden's Innovation Agency, Swedish Research Council Health.

The Lancet. Child & adolescent health · randomised controlled trial · 45 citationsread the source →

Parenting for Lifelong Health for Young Children: a randomized controlled trial of a parenting program in South Africa to prevent harsh parenting and child conduct problems.

Background: Parenting programs suitable for delivery at scale in low-resource contexts are urgently needed. We conducted a randomized trial of Parenting for Lifelong Health (PLH) for Young Children, a low-cost 12-session program designed to increase positive parenting and reduce harsh parenting and conduct problems in children aged 2-9. Methods: Two hundred and ninety-six caregivers, whose children showed clinical levels of conduct problems (Eyberg Child Behavior Inventory Problem Score, >15), were randomly assigned using a 1:1 ratio to intervention or control groups. At t0 , and at 4-5 months (t1 ) and 17 months (t2 ) after randomization, research assistants blind to group assignment assessed (through caregiver self-report and structured observation) 11 primary outcomes: positive parenting, harsh parenting, and child behavior; four secondary outcomes: parenting stress, caregiver depression, poor monitoring/supervision, and social support. Trial registration: ClinicalTrials.gov (NCT02165371); Pan African Clinical Trial Registry (PACTR201402000755243); Violence Prevention Trials Register (http://www.preventviolence.info/Trials?ID=24). Results: Caregivers attended on average 8.4 sessions. After adjustment for 30 comparisons, strongest results were as follows: at t1 , frequency of self-reported positive parenting strategies (10% higher in the intervention group, p = .003), observed positive parenting (39% higher in the intervention group, p = .003), and observed positive child behavior (11% higher in the intervention group, p = .003); at t2, both observed positive parenting and observed positive child behavior were higher in the intervention group (24%, p = .003; and 17%, p = .003, respectively). Results with p-values < .05 prior to adjustment were as follows: At t1 , the intervention group self-reported 11% fewer child problem behaviors, 20% fewer problems with implementing positive parenting strategies, and less physical and psychological discipline (28% and 14% less, respectively). There were indications that caregivers reported 20% less depression but 7% more parenting stress at t1 . Group differences were nonsignificant for observed negative child behavior, and caregiver-reported child behavior, poor monitoring or supervision, and caregiver social support. Conclusions: PLH for Young Children shows promise for increasing positive parenting and reducing harsh parenting.

Journal of child psychology and psychiatry, and allied disciplines · randomised controlled trial · 88 citationsread the source →

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Importance: Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking. Objectives: To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence. Design, setting, and participants: This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017. Interventions: Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking. Main outcomes and measures: Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16. Results: Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, -0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, -0.69; 95% CI, -1.63 to 0.25; P = .15; Cohen d = -0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = -0.60; 95% CI, -1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07). Conclusions and relevance: Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks. Trial registration: clinicaltrials.gov Identifier: NCT01553136.

JAMA psychiatry · randomised controlled trial · 77 citationsread the source →

Appearance-related teasing, body dissatisfaction, and disordered eating: A meta-analysis.

A meta-analysis was conducted to determine the relationship between appearance and weight-based teasing and three outcome measures: body dissatisfaction, restrictive eating, and bulimic behaviors. Four meta-analyses were conducted. Fifty effect sizes (N=10,618) resulted in a moderate effect size of .39 for the relationship between weight teasing and body dissatisfaction; 24 effect sizes (N=7190) resulted in an effect size of .32 for the relationship between appearance teasing and body dissatisfaction; 20 effect sizes (N=4792) resulted in an effect size of .35 for the relationship between weight teasing and dietary restraint; and 22 effect sizes (N=5091) resulted in an effect size of .36 for the relationship between weight teasing and bulimic behaviors. Significant moderators that emerged were teasing measure type, publication type, study type, age group, and gender. The findings offer further support for the inclusion of strategies in body image and eating disorders' prevention and intervention programs that focus on handling negative, appearance-related commentary.

Body image · meta-analysis · 203 citationsread the source →

The Social Epidemiology of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

Social epidemiology is defined as the study of the distribution of health outcomes and their social determinants (1). It builds on the classic epidemiologic triangle of host, agent, and environment to focus explicitly on the role of social determinants in infectious disease transmission and progression. These determinants are the “features of and pathways by which societal conditions affect health” (2, p. 697). Early studies of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) focused on individual characteristics and behaviors in determining HIV risk, an approach that Fee and Krieger (3) refer to as “biomedical individualism.” Biomedical individualism is the basis of risk factor epidemiology; by contrast, the social epidemiology perspective emphasizes social conditions as fundamental causes of disease (4) (table 1). Social epidemiologists examine how persons become exposed to risk or protective factors and under what social conditions individual risk factors are related to disease. Social factors are thus the focus of analysis and are not simply adjusted for as potentially confounding factors or used as proxies for unavailable individual-level data. Social factors are indeed critical to understanding nonuniform infectious disease patterns that emerge as a result of the dependent nature of disease transmission or the idea that an outcome in one person is dependent upon outcomes and exposures in others (5, 6). Contact patterns that enhance HIV/AIDS vulnerability may be conceptualized at multiple levels. Figure 1 distinguishes determinants of HIV/AIDS at three levels: individual, social, and structural. Individual factors include biologic, demographic, and behavioral risk factors that may influence the risk of HIV acquisition and disease progression. Social-level factors include critical pathways by which community and network structures link persons to society. These structures are central to understanding the diffusion and differential distribution of HIV/AIDS in population subgroups. Structural-level factors include social and economic factors, as well as laws and policies. These factors, in turn, affect HIV transmission dynamics and the differential distribution of HIV/AIDS. Infectious disease epidemiology provides models of the mechanisms through which social determinants affect HIV transmission (7). For example, the basic reproductive number of an infectious disease, R0 (8), describes secondary infections that arise from a primary infection. In the equation R0 = βCD, β is the probability of infection per contact, C is the number of contacts, and D is the duration of infectivity. The goal of intervention efforts is to reduce the empirical value of these terms by modifying the social conditions under which individual risk factors lead to disease. Examples of factors that affect the component terms of R0 in HIV epidemiology are presented in table 2. In this review, we present existing evidence linking social and structural determinants to HIV/AIDS. In addition, we discuss the implications of these findings for future social epidemiology research on HIV/AIDS as well as the design of more effective HIV/AIDS interventions. We searched the published literature to identify conceptual and empirical research reports on the social epidemiology of HIV/AIDS. Five databases were searched: PsycINFO (American Psychological Association, Washington, DC), PubMed (MEDLINE; National Institutes of Health, Bethesda, Maryland), Social Science Citation Index (Web of Science; Thomson ISI, Stamford, Connecticut), Sociological Abstracts (CSA, Bethesda, Maryland), and Digital Dissertations (ProQuest; UMI, Ann Arbor, Michigan). Searches were designed to include the factors we specified in our framework as social or structural factors (figure 1). Searches were limited to published articles in the English language for the period 1981–2003. The following keywords were included in each search: AIDS/acquired immunodeficiency syndrome, HIV, and epidemiol*. Additional searches were conducted by using combinations of keywords listed in Appendix table 1 corresponding with our framework. We identified four categories of social-level factors of importance to HIV/AIDS epidemiology: cultural context, social networks, neighborhood effects, and social capital. Each uses different conceptual and methodological approaches to examine the effects of social forces on population HIV/AIDS vulnerability. Anthropologist Edward Tylor defined culture as “that complex whole which includes knowledge, belief, art, law, morals, custom, and any other capabilities and habits acquired by man as a member of society” (9, p. 1). Anthropologic and epidemiologic approaches may be integrated in a variety of ways to identify features of the social environment that affect HIV/AIDS risk. One way to explore how the social environment affects HIV/AIDS epidemiology is through the use of mixed research methods. Mixed-methods study designs integrate qualitative and quantitative research methods either sequentially or concurrently (10). In sequential study designs, qualitative methods may be used to explore a topic under study or to explain quantitative epidemiologic findings. Concurrent study designs are meant to confirm, cross-validate, or corroborate findings within a single study. A common type of concurrent mixed methods study is “triangulation,” and this approach has been used extensively in rapid assessments of illicit drug use and HIV/AIDS (11–13). Mixed methods approaches are particularly well suited to the investigation of the often hidden and stigmatizing behavioral and social factors underlying HIV epidemics. One exemplary study combining qualitative methods with quantitative methods was conducted by Beyrer et al. (14) to examine the role of overland heroin trafficking routes in shaping explosive HIV/AIDS epidemics among injection drug users in Southeast Asia. Piecing together data from a variety of sources, including existing epidemiologic data, key informant interviews, and laboratory data, this study revealed that distinct HIV subtypes emerged and recombined along drug trafficking routes originating in Myanmar, one of the world’s largest heroin producers. Along these trafficking routes, communities of injection drug users formed, facilitating the spread of HIV into local communities in Laos, Thailand, Vietnam, India, and China (refer, for example, to Panda et al. (15)). This illustration highlights the broader understanding of HIV/AIDS epidemiology that can be achieved by examining the interplay between contextual factors and social and behavioral factors. Investigation of social networks in HIV/AIDS began with the mapping of relationships between one of the first identified AIDS cases, an airline steward, and a large number of his male sex partners in the early 1980s (16). Social network analysis generates measures of the quality, density, position, and structure of relationships between persons, including dyads (partnerships), personal networks (“egocentric” networks), and larger communities (“sociometric” networks) (17, 18). Social networks can influence health outcomes in direct and indirect ways, including 1) social influence, 2) social engagement and participation, 3) prevalence of infectious disease and network member mixing, 4) access to material goods and informational resources, and 5) social support (19). Researchers have demonstrated that patterns in the structure of relationships—rather than differences in individual risk behaviors alone—explain observed HIV patterns (20, 21). The theoretical foundation for examining social networks in HIV research is closely tied to advances in sexually transmitted disease (STD) epidemiology. A key concept from STD epidemiology is the notion of the “core group,” a small group of disease transmitters responsible for a large proportion of cases (22). Friedman et al. (23) found that individuals’ locations within sociometric risk networks were associated with HIV risk among a group of injection drug users in New York City. Other concepts from STD epidemiology, such as partner concurrency, bridging, and mixing patterns, are also important in understanding HIV risk (24–29). Specific network characteristics that have been associated with HIV/AIDS include the size of subgroups and their distribution in a network (23), the centrality of HIV-positive persons within networks (30), partner selection patterns (24, 31–33), and concurrent sexual partnerships (28). Inclusion of these variables has been shown to improve transmission estimates in mathematical modeling (34, 35). Social and normative influences have also been associated with individual HIV risks (36, 37). Network-related social and normative influences are predictive of illicit drug use (38) and condom use behavior (37, 39), highlighting the importance of network-based interventions for HIV prevention (18). Kelly et al. (40, 41) developed a popular opinion leader model that has been effective in reducing HIV risk in several populations, including men who have sex with men and women in low-income housing (42). The success of this model has led to its adaption for international use by the National Institute of Mental Health Collaborative HIV/STD Prevention Trial in China, India, Peru, Russia, and Zimbabwe. Neighborhoods represent the intersection of social networks and physical spatial locations, a confluence Wallace (43) has called the “sociogeographic networks” through which infectious diseases spread. Early interest in the role of neighborhood social environment in disease transmission was sparked by a study in Colorado Springs, Colorado, in which researchers found that gonorrhea was highly focused geographically in core residential neighborhoods (44). Both direct and indirect mechanisms may determine how neighborhood-level factors shape population HIV/AIDS patterns. Direct mechanisms are those that increase the likelihood of a person coming into contact with someone who is HIV positive, for example, through residential segregation and the social isolation of marginalized populations. Indirect mechanisms include those that increase population vulnerability to HIV/AIDS, such as exposure to poor socioeconomic conditions, high unemployment, or the proliferation of illicit drug markets. A range of neighborhood-level factors have been examined in relation to infectious disease, including poverty and income (45, 46), residential segregation (47), and neighborhood physical environment (48, 49). Current research in neighborhood and area effects on health emphasizes the importance of moving beyond documentation of associations to analyze the social and epidemiologic mechanisms through which neighborhood effects might operate (50–54). Increasing concentrations of affluence and poverty are contributing to what demographer Douglas Massey has called “a radical change in the geographic basis of human society” (55, p. 395). Powerful social and economic forces in US cities are increasing neighborhood segregation by class and race/ethnicity (56, 57). Resulting social disorganization and loss of resources and services in poor neighborhoods are in turn shaping HIV/AIDS patterns at the neighborhood level. In a number of studies in New York City, for example, Wallace (58–63) has examined the complex interplay of public policies such as “planned shrinkage” with HIV epidemic dynamics in the Bronx, documenting the “synergy of plagues” that has accompanied rapid social change and the destruction of essential protective networks in poor communities. Using AIDS surveillance data, ecologic studies conducted in various US cities have also consistently found significant associations between income and poverty measures and neighborhood-level AIDS incidence and prevalence rates, and these findings have been consistent across census block groups (46), census tracts (64), and zip codes (65, 66). Length of survival an AIDS has also been with neighborhood measures of income and the of highly a of health at the population may also a role in shaping HIV/AIDS patterns, associations between HIV/AIDS and income at the neighborhood have not been well segregation by race/ethnicity is neighborhood-level that may an important role in HIV/AIDS may affect infectious disease patterns through the and isolation of persons in one increasing the probability of transmission within that For example, found that measures of residential isolation were protective for at risk of disease. 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The of evidence ecologic associations between neighborhood-level factors and infectious disease that to be to identify of and defined social as of social structures that that is the of that in its not be p. Social may affect health through 1) the of 2) access to services and 3) of in a and 4) participation, to policies that are more to published studies have explicitly examined social in the of HIV/AIDS. 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Epidemiologic Reviews · meta-analysis · 394 citationsread the source →

Effectiveness of one-year pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD): an open-label prospective study of time in treatment, dose, side-effects and comorbidity.

How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to 'real-world' clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, P<0.001) and greater improvement of GAF (median 20% versus 4%, P<0.001) and secondary outcomes. Continued medication and higher cumulated doses showed significant associations to sustained improvement. Conversely, psychiatric comorbidity and side-effects were related to lower effectiveness and more frequent termination of medication. Taken together, one-year treatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · cohort or longitudinal · 37 citationsread the source →

The Price of the Ticket: Health Costs of Upward Mobility among African Americans.

There is a growing literature that has documented diminishing health returns on upward social mobility among Black Americans. Due to historical policies and practices, upward social mobility is often an arduous, isolating process for Black Americans, especially as they navigate predominately white educational and workplace settings. This paper advances the literature in several meaningful and innovative ways. The goal of this paper is to provide a qualitative account of the health costs of upward social mobility and describe how these costs could diminish health returns despite greater levels of socioeconomic resources. Focus groups and surveys were the data collection methods for the study. Inclusion criteria for the study were that respondents identified as African American or Black, were 24 years or older and had completed college. The total sample was 32 college-educated Black men (n = 12) and women (n = 20). The mean age for men was 39 (range = 26-50) and 33 years of age (range = 24-59) for women. Key findings highlighted in this paper include (1) hypervisibility and subsequent vigilance; (2) uplift stress; and (3) health costs associated with social mobility. The sum of these stressors is posited to affect multiple health outcomes and elucidate the mechanisms through which socioeconomic returns on health are diminished.

International journal of environmental research and public health · 80 citationsread the source →

Stress-related thinking predicts the cortisol awakening response and somatic symptoms in healthy adults.

Objective: Perseverative cognition (i.e., worry, stress-related thinking) may prolong stress-related physiological activation. However, its role within the context of the written emotional disclosure paradigm has not been examined. This study explored: (1) the effects of stress-related thinking on the cortisol awakening response and upper respiratory infection symptoms and; (2) the efficacy of two expressive writing interventions on these health outcomes. Methods: Participants were randomly assigned to write about their most stressful life experience (using the Guided Disclosure Protocol; n=39) or positive life experiences (n=42) or plans for the day (n=41) for 20 min on 3 consecutive days. Participants reported the extent to which they thought about their assigned writing topic during the study and in the past (event-related thought). Cortisol was measured at 0, 15, 30 and 45 min after awakening on 2 consecutive days at baseline and 4 weeks post-intervention. Upper respiratory infection (URI) symptoms were assessed at baseline, at 4 weeks and at 6 months. Results: Results showed that the writing interventions had no beneficial effects on any of the outcome measures. However, a significant interaction was found between event-related thought and condition on the cortisol awakening response at 1 month follow-up and URI symptoms at 6 months. Among participants who wrote about stressful/traumatic events, higher stress-related thinking during the study predicted increased cortisol levels and URI symptoms compared to participants who reported low stress-related thinking. Discussion: These findings are broadly consistent with Brosschot et al.'s (2006) perseverative cognition hypothesis and highlight the importance of ruminative thinking in understanding stress-health processes.

Psychoneuroendocrinology · randomised controlled trial · 23 citationsread the source →

Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.

Background: Circadian rhythm sleep disorders are common causes of insomnia for millions of individuals. We did a phase II study to establish efficacy and physiological mechanism, and a phase III study to confirm efficacy of the melatonin agonist tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time. Methods: We undertook phase II and phase III randomised, double-blind, placebo-controlled, parallel-group studies. In a phase II study, 39 healthy individuals from two US sites were randomly assigned to tasimelteon (10 [n=9], 20 [n=8], 50 [n=7], or 100 mg [n=7]) or placebo (n=8). We monitored individuals for 7 nights: 3 at baseline, 3 after a 5-h advance of sleep-wake schedule with treatment before sleep, and 1 after treatment; we measured plasma melatonin concentration for circadian phase assessment. In a phase III study, 411 healthy individuals from 19 US sites, who had transient insomnia induced in a sleep clinic by a 5-h advance of the sleep-wake schedule and a first-night effect in a sleep clinic, were given tasimelteon (20 [n=100], 50 [n=102], or 100 mg [n=106]) or placebo (n=103) 30 min before bedtime. Prespecified primary efficacy outcomes were polysomnographic sleep efficiency (phase II study), latency to persistent sleep (phase III study), and circadian phase shifting (phase II study). Analysis was by intention to treat. Safety was assessed in both studies. These trials are registered with ClinicalTrials.gov, numbers NCT00490945 and NCT00291187. Findings: In the phase II study, tasimelteon reduced sleep latency and increased sleep efficiency compared with placebo. The shift in plasma melatonin rhythm to an earlier hour was dose dependent. In the phase III study, tasimelteon improved sleep latency, sleep efficiency, and wake after sleep onset (ie, sleep maintenance). The frequency of adverse events was similar between tasimelteon and placebo. Interpretation: After an abrupt advance in sleep time, tasimelteon improved sleep initiation and maintenance concurrently with a shift in endogenous circadian rhythms. Tasimelteon may have therapeutic potential for transient insomnia in circadian rhythm sleep disorders.

Lancet (London, England) · randomised controlled trial · 140 citationsread the source →

Mental health and psychosocial support in humanitarian settings: linking practice and research.

This review links practice, funding, and evidence for interventions for mental health and psychosocial wellbeing in humanitarian settings. We studied practice by reviewing reports of mental health and psychosocial support activities (2007-10); funding by analysis of the financial tracking service and the creditor reporting system (2007-09); and interventions by systematic review and meta-analysis. In 160 reports, the five most commonly reported activities were basic counselling for individuals (39%); facilitation of community support of vulnerable individuals (23%); provision of child-friendly spaces (21%); support of community-initiated social support (21%); and basic counselling for groups and families (20%). Most interventions took place and were funded outside national mental health and protection systems. 32 controlled studies of interventions were identified, 13 of which were randomised controlled trials (RCTs) that met the criteria for meta-analysis. Two studies showed promising effects for strengthening community and family supports. Psychosocial wellbeing was not included as an outcome in the meta-analysis, because its definition varied across studies. In adults with symptoms of post-traumatic stress disorder (PTSD), meta-analysis of seven RCTs showed beneficial effects for several interventions (psychotherapy and psychosocial supports) compared with usual care or waiting list (standardised mean difference [SMD] -0·38, 95% CI -0·55 to -0·20). In children, meta-analysis of four RCTs failed to show an effect for symptoms of PTSD (-0·36, -0·83 to 0·10), but showed a beneficial effect of interventions (group psychotherapy, school-based support, and other psychosocial support) for internalising symptoms (six RCTs; SMD -0·24, -0·40 to -0·09). Overall, research and evidence focuses on interventions that are infrequently implemented, whereas the most commonly used interventions have had little rigorous scrutiny.

Lancet (London, England) · systematic review · 289 citationsread the source →

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial.

Background: Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available. Objective: To determine the safety and feasibility of single fraction SABR for patients with oligometastatic prostate cancer. Secondary endpoints were local and distant progression-free survival (LPFS and DPFS), toxicity, quality of life (QoL), and prostate-specific antigen response. Design, setting, and participants: In a prospective clinical trial, patients were screened with computed tomography, bone scan, and sodium fluoride positron emission tomography scan and had one to three oligometastases. Kaplan-Meier methods were used to determine LPFS and DPFS. Toxicity was graded using Common Terminology Criteria for Adverse Event version 4.0. QoL was assessed using European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-BM22 at 1, 3,12, and 24 mo. Intervention: A single fraction of 20-Gy SABR to each lesion. Results and limitations: Between 2013 and 2014, 33 consecutive patients received SABR to a total of 50 oligometastases and were followed for 2 yr. The median age was 70 yr. The Gleason score was ≥8 in 15 patients (45%). Twenty patients had bone only, 12 had node only, and one had mixed disease. SABR was feasible and delivered as planned in 97% of cases. There was one grade 3 adverse event (3.0%, vertebral fracture). No patient died. The 1 and 2-yr LPFS was 97% (95% confidence interval [CI]: 91-100) and 93% (95% CI: 84-100), and DPFS was 58% (95% CI: 43-77) and 39% (95% CI: 25-60), respectively. In those not on androgen deprivation therapy (ADT; n=22), the 2-yr freedom from ADT was 48%. There was no significant difference from baseline QoL observed. Limitations include small sample size, limited duration of follow-up, and lack of a control arm. Conclusions: A single SABR session was feasible and associated with low morbidity in this cohort. Over one-third of patients did not progress and were free from ADT at 2-yr. QoL measures were maintained with this treatment strategy. Patient summary: This clinical trial investigated single treatment stereotactic radiotherapy for low volume advanced prostate cancer. The approach was found to be safe with avoidance of hormone therapy in almost half of the participants at 2 yr.

European urology · clinical trial · 222 citationsread the source →

Check it! A randomized pilot of a positive psychology intervention to improve adherence in adolescents with type 1 diabetes.

Purpose: The purpose of the current study was to pilot-test a positive psychology intervention to improve adherence to diabetes management in adolescents with type 1 diabetes. Methods: A total of 39 adolescents (ages, 13-17 years) with type 1 diabetes and their caregivers were randomized to a positive psychology intervention (n = 20) or an attention control (education) intervention (n = 19). The intervention condition used positive psychology exercises (eg, gratitude, self-affirmation), small gifts, and parent affirmations to boost positive affect. Outcomes included frequency of blood glucose monitoring, quality of life, and glycemic control. Results: No main effects for treatment were observed at the 6-month follow-up. However, there was a significant association between adolescents' levels of positive affect and measures of adherence, including self-report and meter downloads of glucose monitoring. Conclusions: The results from the current study support the assertion that positive affect in the context of diabetes education is an important factor to consider in adolescents with type 1 diabetes.

The Diabetes educator · randomised controlled trial · 36 citationsread the source →

Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

Pain · randomised controlled trial · 100 citationsread the source →

A communication strategy and brochure for relatives of patients dying in the ICU.

Background: There is a need for close communication with relatives of patients dying in the intensive care unit (ICU). We evaluated a format that included a proactive end-of-life conference and a brochure to see whether it could lessen the effects of bereavement. Methods: Family members of 126 patients dying in 22 ICUs in France were randomly assigned to the intervention format or to the customary end-of-life conference. Participants were interviewed by telephone 90 days after the death with the use of the Impact of Event Scale (IES; scores range from 0, indicating no symptoms, to 75, indicating severe symptoms related to post-traumatic stress disorder [PTSD]) and the Hospital Anxiety and Depression Scale (HADS; subscale scores range from 0, indicating no distress, to 21, indicating maximum distress). Results: Participants in the intervention group had longer conferences than those in the control group (median, 30 minutes [interquartile range, 19 to 45] vs. 20 minutes [interquartile range, 15 to 30]; P<0.001) and spent more of the time talking (median, 14 minutes [interquartile range, 8 to 20] vs. 5 minutes [interquartile range, 5 to 10]). On day 90, the 56 participants in the intervention group who responded to the telephone interview had a significantly lower median IES score than the 52 participants in the control group (27 vs. 39, P=0.02) and a lower prevalence of PTSD-related symptoms (45% vs. 69%, P=0.01). The median HADS score was also lower in the intervention group (11, vs. 17 in the control group; P=0.004), and symptoms of both anxiety and depression were less prevalent (anxiety, 45% vs. 67%; P=0.02; depression, 29% vs. 56%; P=0.003). Conclusions: Providing relatives of patients who are dying in the ICU with a brochure on bereavement and using a proactive communication strategy that includes longer conferences and more time for family members to talk may lessen the burden of bereavement. (ClinicalTrials.gov number, NCT00331877.)

The New England journal of medicine · randomised controlled trial · 820 citationsread the source →

Comparing effects in regular practice of e-communication and Web-based self-management support among breast cancer patients: preliminary results from a randomized controlled trial.

Background: While Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care. Objective: Our aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months' follow-up data in a 12-month trial. Methods: We recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time. Results: Patients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups. Conclusions: In spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects. Trial registration: Clinicaltrials.gov:NCT00971009; http://clinicaltrials.gov/show/NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y).

Journal of medical Internet research · randomised controlled trial · 105 citationsread the source →

The Marriage Checkup: a randomized controlled trial of annual relationship health checkups.

Objective: This study assessed the efficacy of the Marriage Checkup (MC) for improving relationship health and intimacy. Method: Cohabiting married couples (N = 215, Mage women = 44.5 years, men = 47 years, 93.1% Caucasian) recruited from a northeastern U.S. metropolitan area through print and electronic media were randomly assigned to MC treatment or wait-list control. Treatment but not control couples participated in assessment and feedback visits, at the beginning of the study and again 1 year later. All couples completed 9 sets of questionnaires over 2 years. Outcome measures included the Quality of Marriage Index, the Global Distress subscale of the Marital Satisfaction Inventory-Revised, the Intimate Safety Questionnaire, and the Relational Acceptance Questionnaire. Results: A latent growth curve model indicated significant between-group differences in intimacy at every measurement point after baseline (d ranged from .20 to .55, Md = .37), significant between-group differences in women's felt acceptance for every measurement point after baseline (d ranged from .17 to .47, Md = .34), significant between-group differences in men's felt acceptance through the 1-year 2-week follow-up (d across follow-up ranged from .11 to .40, Md = .25), and significant between-group differences in relationship distress through 1-year 6-month follow-up (d across follow-up ranged from .11 to .39, Md = .23). Conclusions: Longitudinal analysis of the MC supports the hypothesis that the MC significantly improves intimacy, acceptance, and satisfaction. Implications for dissemination are discussed.

Journal of consulting and clinical psychology · randomised controlled trial · 58 citationsread the source →

Efficacy of a novel biphasic controlled-release methylphenidate formula in adults with attention-deficit/hyperactivity disorder: results of a double-blind, placebo-controlled crossover study.

Objective: To evaluate the efficacy and safety of a new biphasic multilayer-release (MLR) methylphenidate formulation in a double-blind, placebo-controlled crossover study of adults with attention-deficit/hyperactivity disorder (ADHD). Method: Adults 18 to 60 years of age with a DSM-IV diagnosis of ADHD entered a no-medication baseline week and were then randomly assigned to once-daily MLR methylphenidate or matching placebo. Patients were titrated to optimal effect over 1 to 3 weeks followed by 2 weeks of treatment on a stable dose. The same titration protocol was repeated with the alternate treatment. Clinical Global Impressions scale (CGI) and Conners' Adult ADHD Rating Scales (Self-rated, CAARS-S, and Observer-rated, CAARS-O) were collected at weekly clinic visits. The study was conducted between October 2003 and April 2004. Results: Fifty patients were randomly assigned to treatment, and 39 were analyzed in a per-protocol population (23 men, 16 women; mean age = 37.9 years). CGI-Improvement scores of subjects taking MLR methylphenidate were significantly improved compared with placebo (Global Improvement: 2.6 vs. 3.7; p = .0015). MLR methylphenidate produced improvements over placebo on the ADHD Index T scores of the CAARS-S (12.2 vs. 5.4 [change from baseline score]; p = .0083) and the CAARS-O (10.9 vs. 6.6 [change from baseline score]; p = .1404). The most frequent adverse events for MLR methylphenidate and placebo were headache (26% and 24%, respectively), anorexia (22% and 6%), insomnia (22% and 8%), nervousness (20% and 4%), and nausea (16% and 8%). There were no serious adverse events. Conclusions: Once-daily MLR methylphenidate produces significant improvements in ADHD symptoms and situational behavior in adult patients with ADHD, with a prolonged duration of effect and minimal side effects, thus having the potential to improve compliance and, therefore, treatment outcomes in routine clinical use.

The Journal of clinical psychiatry · randomised controlled trial · 37 citationsread the source →

Effects of nurse home visitation on cigarette smoking, pregnancy outcomes and breastfeeding: a randomized controlled trial.

Objective: antenatal smoking is more prevalent among young women with low socio-economic status. The aim of our study is to assess whether the VoorZorg programme, compared to usual care, is effective in reducing cigarette smoking among young high risk pregnant women. Furthermore, the effect of VoorZorg on pregnancy outcomes and on breast feeding will be described. Design: a randomised controlled trial of VoorZorg, a nurse home visitation intervention, was undertaken over a 2½ year period from 2007 to 2009. Data were collected between 16 and 28 weeks gestation, 32 weeks gestation and at two months post partum on cigarette smoking status plus six months post partum for breastfeeding prevalence. Neonatal birth weight and gestation at birth were also collected. Setting: participants living in 20 municipalities in the Netherlands. Participants: 460 pregnant women were recruited by different professionals. Inclusion criteria were age <26 years, ≤28 weeks pregnancy with the first child, low educational level and some knowledge of the Dutch language. Interventions: women in the intervention group received, in addition to usual care, the VoorZorg programme which consisted of 40-60 home visits by specialised nurses from pregnancy until two years after birth. Findings: the percentage of smokers was significantly lower in the intervention group (40%) compared to the control group (48%) during pregnancy (p=0.03) and at two months post birth (49% and 62%; p=0.02). During pregnancy the number of daily cigarettes smoked was reduced in both groups. After birth, the intervention group smoked 50% less cigarettes compared to the control group (C: 8±10; I: 4±7 (mean±standard deviation (SD)), p=0.01). Furthermore, women in the intervention group did not smoke near the baby (C: 2±5; I: 0±0 (mean±SD) p=0.03). Birth weight and gestational age were similar in both groups (C: 3147g, 40 weeks; I: 3144g, 39 weeks (p=0.94, p=0.17)). Significantly more women in the intervention group were still breast feeding their baby at six months post -birth (C: 6%; I: 13%, p=0.04). Key conclusions: VoorZorg seemed to be effective in reducing cigarette smoking and in increasing breastfeeding duration. No effect was found on pregnancy outcomes.

Midwifery · randomised controlled trial · 57 citationsread the source →

Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study.

Background: We sought to assess a novel, noninvasive, portable vagal nerve stimulator (nVNS) for acute treatment of migraine. Methods: Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain. Results: Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n = 1), raspy voice (n = 1) and redness at the device site (n = 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%). Conclusions: nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients.

Cephalalgia : an international journal of headache · clinical trial · 140 citationsread the source →

Impact of an Elementary School-Based Intervention on Physical Activity Time and Aerobic Capacity, Georgia, 2013-2014.

Objectives: The objectives of this study were to (1) determine the impact of a 1-year elementary school physical activity intervention on changes in teacher-reported school-based physical activity time and (2) assess the relationship between these changes and changes in student aerobic capacity. Methods: HealthMPowers, a nonprofit organization, provided a multicomponent physical activity intervention to 3479 students in 39 schools in Georgia during 2013-2014. HealthMPowers administered a survey to faculty members before (August 2013) and after (May 2014) the intervention to measure student physical activity times. The organization collected pre- and post-intervention Progressive Aerobic Cardiovascular Endurance Run (PACER) laps (a measure of aerobic capacity that awards 1 lap for each completed 20-meter lap) for 2342 fourth-grade students. We performed linear regression to determine the relationship between school-level changes in teacher-reported school-based physical activity time and student aerobic capacity. Results: The weekly estimated teacher-reported time in physical activity increased by 39 minutes from pre- to post-intervention: 21 minutes for recess, 17 minutes for classroom, and 1 minute for physical education. The mean number of student PACER laps increased by 3 laps from pre- to post-intervention, and 1515 of 2342 (65%) students increased the number of PACER laps completed. We observed a positive association between school-level changes in school-based physical activity time and school-level changes in PACER laps ( r = 0.38; 95% confidence interval, 0.29-0.46). Conclusions: These findings highlight the need for more prospective research into multicomponent physical activity interventions. Rigorous testing, including randomized controlled trials of large-scale implementations, is needed to examine how these school-based interventions might be used to improve the physical activity and fitness of larger populations of children.

Public health reports (Washington, D.C. : 1974) · cohort or longitudinal · 17 citationsread the source →

Emotional orienting during interoceptive threat in orthostatic intolerance: Dysautonomic contributions to psychological symptomatology in the postural tachycardia syndrome and vasovagal syncope.

Cognitive and emotional processes are influenced by interoception (homeostatic somatic feedback), particularly when physiological arousal is unexpected and discrepancies between predicted and experienced interoceptive signals may engender anxiety. Due to the vulnerability for comorbid psychological symptoms in forms of orthostatic intolerance (OI), this study investigated psychophysiological contributions to emotional symptomatology in 20 healthy control participants (13 females, mean age 36 ± 8 years), 20 postural tachycardia syndrome (PoTS) patients (18 females, mean age 38 ± 13 years) and 20 vasovagal syncope (VVS) patients (15 females, mean age 39 ± 12 years). We investigated indices of emotional orienting responses (OR) to randomly presented neutral, pleasant and unpleasant images in the supine position and during the induced interoceptive threat of symptom provocation of head-up tilt (HUT). PoTS and VVS patients produced greater indices of emotional responsivity to unpleasant images and, to a lesser degree, pleasant images, during interoceptive threat. Our findings are consistent with biased deployment of response-focused emotion regulation (ER) while patients are symptomatic, providing a mechanistic underpinning of how pathological autonomic overexcitation predisposes to anxiogenic traits in PoTS and VVS patients. This hypothesis may improve our understanding of why orthostasis exacerbates cognitive symptoms despite apparently normal cerebral autoregulation, and offer novel therapeutic targets for behavioural interventions aimed at reducing comorbid cognitive-affective symptoms in PoTS and VVS.

Autonomic neuroscience : basic & clinical · 18 citationsread the source →

Breastfeeding outcome comparison by parity.

Objective: Anecdotally, breastfeeding experiences differ between those who have previously nursed an infant and those who are primiparous. This analysis contrasted breastfeeding outcomes between primiparous women and those with previous experience spanning from maternity stay through 6 months postpartum. Study design: A secondary analysis was conducted of data collected in a randomized, controlled trial with mothers and "well" newborns ≥34 weeks of gestation comparing two post-hospital discharge care models. Mothers completed an in-person interview during the postpartum stay and phone surveys at 2 weeks, 2 months, and 6 months where questionnaires related to breastfeeding were completed. All participants intended to breastfeed. Chi-squared and Wilcoxon rank sum tests were used to test for differences between parity groups. Breastfeeding duration by parity group was compared using a Kaplan-Meier plot and a logrank test. A Cox proportional hazards model was used to evaluate the relationship between breastfeeding duration and parity after adjusting for covariates. Results: Among 1,099 mothers available for analysis, 542 (49%) were primiparous. Multiparous mothers had a longer intended breastfeeding duration (median, 9 vs. 6 months; p<0.001). Following delivery, primiparous mothers had a longer median time to first breastfeeding attempt (119 vs. 96 minutes; p<0.001) and were more likely to have eight or fewer feeding attempts in the first 24 hours (33% vs. 44%; p<0.001)). More primiparous women reported early breastfeeding problems (35% vs. 20%; p<0.001) and mixed feeding at hospital discharge (39% vs. 23%; p<0.001) despite reporting less breastfeeding-associated pain during the first week (p=0.04). Multiparous women were more likely to breastfeed through 6 months (p<0.001). In a multivariable Cox model for breastfeeding duration, an interaction existed between intended breastfeeding duration and parity (p=0.006); among those intending to breastfeed for 12 months, multiparous mothers had a significantly lower hazard of stopping breastfeeding (hazard ratio=0.66; p=0.03) than primiparous mothers. Conclusions: Women who have breastfed previously have significantly different breastfeeding experiences than primiparous women. Pre- and postdelivery breastfeeding support should differentially target primiparous women to improve breastfeeding outcomes.

Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 108 citationsread the source →