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Effects of a 4-week transitional care programme for discharged stroke survivors in Hong Kong: a randomised controlled trial.

Stroke rehabilitation involves care issues concerning the physical, psychosocial and spiritual aspects. Hospital-based rehabilitation has its limitations because many of the care issues only emerge when patients return home. Transitional care models supporting patients after discharge from the hospital have proved to be effective among chronically ill patients, but limited studies were conducted among stroke survivors. This study was a randomised controlled trial conducted to test the effectiveness of a transitional care programme (TCP) which was a nurse-led 4-week programme designed based on the assessment-intervention-evaluation Omaha System framework. Between August 2010 and October 2011, 108 stroke patients who were discharged home, able to communicate, and had slight to moderate neurological deficits and disability were randomised into control (n = 54) and intervention groups (n = 54). Data on the patient-related and clinical outcomes were collected at baseline, 4 weeks when the TCP was completed and 8 weeks after discharge from hospital. Repeated measures analysis of variance with intention-to-treat strategy was used to examine the outcomes. There were significant between-group differences in quality of life, the primary outcome measure of this study, in both physical (F(1, 104) = 10.15, P = 0.002) and mental (F(1, 104) = 8.41, P = 0.005) domains, but only the physical domain achieved a significant time × intervention interaction effect (F(1, 103) = 7.73, P = 0.006). The intervention group had better spiritual-religion-personal measures, higher satisfaction, higher Modified Barthel Index scores and lower depression scores when compared with the control group. They also had lower hospital readmission and use of emergency room rates, but only the use of emergency room had significant difference when compared to control. This study is original in testing a transitional model among stroke patients discharged from hospital. The TCP shares common features that have been proved to be effective when applied to chronically ill patients, and the duration of 4 weeks seems to be adequate to bring about immediate effects.

Health & social care in the community · randomised controlled trial · 66 citationsread the source →

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

A parenting intervention for childhood behavioral problems: a randomized controlled trial in disadvantaged community-based settings.

Objective: A community-based randomized controlled trial (RCT) was conducted in urban areas characterized by high levels of disadvantage to test the effectiveness of the Incredible Years BASIC parent training program (IYBP) for children with behavioral problems. Potential moderators of intervention effects on child behavioral outcomes were also explored. Method: Families were included if the child (aged 32-88 months) scored above a clinical cutoff on the Eyberg Child Behavior Inventory (ECBI). Participants (n = 149) were randomly allocated on a 2:1 ratio to an intervention group (n = 103) or a waiting-list control group (n = 46). Child behavior, parenting skills, and parent well-being were assessed at baseline and 6 months later using parent-report and independent observations. An intention-to-treat analysis of covariance was used to examine postintervention differences between groups. Results: Statistically significant differences in child disordered behavior favored the intervention group on the ECBI Intensity (effect size = 0.7, p < .001) and Problem subscales (effect size = 0.75, p < .001). Intervention effects on child hyperactive-inattentive behaviors and social competence, as well as parent competencies and well-being, were also found. Moderator analyses showed that the effects of the IYBP intervention on the primary child outcomes were not moderated by child or family demographic characteristics or risk factors. Conclusion: The results demonstrate the effectiveness of the IYBP in alleviating problem behavior among children and in improving well-being among families living in disadvantaged areas. The findings also highlight the importance of parental intervention in early childhood for parents and children most in need of support.

Journal of consulting and clinical psychology · randomised controlled trial · 65 citationsread the source →

A Novel Approach to Tackling Bullying in Schools: Personality-Targeted Intervention for Adolescent Victims and Bullies in Australia.

Objective: To examine the secondary effects of a personality-targeted intervention on bullying and harms among adolescent victims and bullies. Method: Outcomes were examined for victims and bullies in the Climate and Preventure study, Australia. Participants completed self-report measures at baseline and four follow-up assessments (6, 12, 24, and 36 months). Thirteen intervention schools (n = 1,087) received Preventure, a brief personality-targeted cognitive-behavioral therapy intervention for adolescents with high-risk personality types (hopelessness, anxiety sensitivity, impulsivity, sensation seeking). Thirteen control schools (n = 1,103) received health education as usual. Bullying was examined for high-risk victims (n = 143 in Preventure schools versus n = 153 in control schools) and bullies (n = 63 in Preventure schools versus n = 67 in control schools) in the total sample. Harms were examined for high-risk victims (n = 110 in Preventure schools versus n = 87 in control schools) and bullies (n = 50 in Preventure schools versus n = 30 in control schools) in independent schools. Results: There was no significant intervention effect for bullying victimization or perpetration in the total sample. In the subsample, mixed models showed greater reductions in victimization (b = -0.208, 95% CI -0.4104 to -0.002, p < .05), suicidal ideation (b = -0.130, 95% CI -0.225 to -0.034, p < .01), and emotional symptoms (b = -0.263, 95% CI -0.466 to -0.061, p < .05) among high-risk victims in Preventure versus control schools. Conduct problems (b = -0.292, 95% CI -0.554 to -0.030, p < .05) showed greater reductions among high-risk bullies in Preventure versus control schools, and suicidal ideation showed greater reductions among high-risk female bullies in Preventure versus control schools (b = -0.820, 95% CI -1.198 to -0.442, p < .001). Conclusion: The findings support targeting personality in bullying prevention. Clinical trial registration information: The CAP Study: Evaluating a Comprehensive Universal and Targeted Intervention Designed to Prevent Substance Use and Related Harms in Australian Adolescents; http://www.anzctr.org.au/; ACTRN12612000026820.

Journal of the American Academy of Child and Adolescent Psychiatry · 20 citationsread the source →

Self-control and cooperation in childhood as antecedents of less moral disengagement in adolescence.

Moral disengagement is a social cognition people use to engage in wrongdoings even when they know it is wrong. However, little is known about the antecedents that predict moral disengagement. The current study focuses on the development of self-control and cooperation during middle childhood as two antecedents of moral disengagement among 1,103 children (50% female; 77% White, 12% Black, 6% Hispanic, and 5% other). Children's self-control at age 8 and growth in self-control from age 8 to 11 were positively linked to adolescents seeing themselves as having self-control at age 15, which then predicted less moral disengagement at age 18. Children's cooperation at age 8 also was positively linked to adolescents' self-views of cooperation at age 15, which in turn, was associated with less moral disengagement at age 18. These findings demonstrate the potential of self-control and cooperation as intrapersonal and interpersonal strengths during middle childhood for mitigating moral disengagement 10 years later.

Development and psychopathology · 4 citationsread the source →

Do Children with Better Inhibitory Control Donate More? Differentiating between Early and Middle Childhood and Cool and Hot Inhibitory Control.

Inhibitory control may play an important part in prosocial behavior, such as donating behavior. However, it is not clear at what developmental stage inhibitory control becomes associated with donating behavior and which aspects of inhibitory control are related to donating behavior during development in early to middle childhood. The present study aimed to clarify these issues with two experiments. In Experiment 1, 103 3- to 5-year-old preschoolers completed cool (Stroop-like) and hot (delay of gratification) inhibitory control tasks and a donating task. The results indicated that there were no relationships between cool or hot inhibitory control and donating behavior in the whole group and each age group of the preschoolers. In Experiment 2, 140 elementary school children in Grades 2, 4, and 6 completed cool (Stroop-like) and hot (delay of gratification) inhibitory control tasks and a donating task. The results showed that inhibitory control was positively associated with donating behavior in the whole group. Cool and hot inhibitory control respectively predicted donating behavior in the second and sixth graders. Therefore, the present study reveals that donating behavior increasingly relies on specific inhibitory control, i.e., hot inhibitory control as children grow in middle childhood.

Frontiers in psychology · 12 citationsread the source →

Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner abuse.

Background: Intimate partner abuse is common worldwide, damaging the short- and long-term physical, mental, and emotional health of survivors and children. Advocacy may contribute to reducing abuse, empowering women to improve their situation by providing informal counselling and support for safety planning and increasing access to different services. Advocacy may be a stand-alone service, accepting referrals from healthcare providers, or part of a multi-component (and possibly multi-agency) intervention provided by service staff or others. Objectives: To assess the effects of advocacy interventions within or outside healthcare settings in women who have experienced intimate partner abuse. Search methods: In April 2015, we searched CENTRAL, Ovid MEDLINE, EMBASE, and 10 other databases. We also searched WHO ICTRP, mRCT, and UK Clinical Research Network (UKCRN), and examined relevant websites and reference lists with forward citation tracking of included studies. For the original review we handsearched six key journals. We also contacted first authors of eligible papers and experts in the field. Selection criteria: Randomised or quasi-randomised controlled trials comparing advocacy interventions for women with experience of intimate partner abuse versus no intervention or usual care (if advocacy was minimal and fewer than 20% of women received it). Data collection and analysis: Two review authors independently assessed risk of bias and undertook data extraction. We contacted authors for missing information needed to calculate statistics for the review and looked for adverse events. Main results: We included 13 trials involving 2141 participants aged 15 to 65 years, frequently having low socioeconomic status. The studies were quite heterogeneous in terms of methodology, study processes and design, including with regard to the duration of follow-up (postintervention to three years), although this was not associated with differences in effect. The studies also had considerable clinical heterogeneity in relation to staff delivering advocacy; setting (community, shelter, antenatal, healthcare); advocacy intensity (from 30 minutes to 80 hours); and abuse severity. Three trials evaluated advocacy within multi-component interventions. Eleven measured some form of abuse (eight scales), six assessed quality of life (three scales), and six measured depression (three scales). Countries and ethnic groups varied (one or more minority ethnic groups in the USA or UK, and local populations in Hong Kong and Peru). Setting was associated with intensity and duration of advocacy. Risk of bias was high in five studies, moderate in five, and low in three. The quality of evidence (considering multiple factors such as risk of bias, study size, missing data) was moderate to low for brief advocacy and very low for intensive advocacy. Incidence of abuse Physical abuseModerate quality pooled data from two healthcare studies (moderate risk of bias) and one community study (low risk of bias), all with 12-month follow-up data, showed no effect on physical abuse for brief (< 12 hours) advocacy interventions (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) - 0.17 to 0.16; n = 558). One antenatal study (low risk of bias) showed an association between brief advocacy and reduced minor physical abuse at one year (mean difference (MD) change - 1.00, 95% CI - 1.82 to - 0.18; n = 110). An antenatal, multi-component study showed a greater likelihood of physical abuse ending (odds ratio (OR) 0.42, 95% CI 0.23 to 0.75) immediately after advocacy (number needed to treat (NNT) = 8); we cannot exclude impact from other components. Low to very low quality evidence from two intensive advocacy trials (12 hours plus duration) showed reduced severe physical abuse in women leaving a shelter at 24 months (OR 0.39, 95% CI 0.20 to 0.77; NNT = 8), but not at 12 or 36 months. Sexual abuseMeta-analysis of two studies (n = 239) showed no effect of advocacy on sexual abuse (SMD - 0.12, 95% CI - 0.37 to 0.14), agreeing with the change score (MD - 0.07, 95% CI - 0.30 to 0.16) from a third study and the OR (0.96, 95% CI 0.44 to 2.12) from a fourth antenatal, multi-component study. Emotional abuseOne study in antenatal care, rated at low risk of bias, showed reduced emotional abuse at ≤ 12-month follow-up (MD (change score) - 4.24, 95% CI - 6.42 to - 2.06; n = 110). Psychosocial health Quality of lifeMeta-analysis of two studies (high risk of bias) showed intensive advocacy slightly improved overall quality of life of women recruited from shelters (MD 0.23, 95% CI 0.00 to 0.46; n = 343) at 12-month follow-up, with greater improvement in perceived physical quality of life from a primary care study (high risk of bias; MD 4.90, 95% CI 0.98 to 8.82) immediately postintervention. Depression Meta-analysis of two studies in healthcare settings, one at high risk of bias and one at moderate risk, showed that fewer women developed depression (OR 0.31, 95% CI 0.15 to 0.65; n = 149; NNT = 4) with brief advocacy. One study at high risk of bias reported a slight reduction in depression in pregnant women immediately after the intervention (OR 0.51, 95% CI 0.20 to 1.29; n = 103; NNT = 8).There was no evidence that intensive advocacy reduced depression at ≤ 12-month follow-up (MD - 0.14, 95% CI - 0.33 to 0.05; 3 studies; n = 446) or at two years (SMD - 0.12, 95% CI - 0.36 to 0.12; 1 study; n = 265). Adverse effectsTwo women died, one who was murdered by her partner and one who committed suicide. No evidence links either death to study participation. Authors' conclusions: Results suggest some benefits from advocacy. However, most studies were underpowered. Clinical and methodological heterogeneity largely precluded pooling of trials. Therefore, there is uncertainty about the magnitude of benefit, the impact of abuse severity, and the setting. Based on the evidence reviewed, intensive advocacy may improve short-term quality of life and reduce physical abuse one to two years after the intervention for women recruited from domestic violence shelters or refuges. Brief advocacy may provide small short-term mental health benefits and reduce abuse, particularly in pregnant women and for less severe abuse.

The Cochrane database of systematic reviews · meta-analysis · 114 citationsread the source →

Exercise training for bronchiectasis.

Background: Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established. Objectives: To determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis. Search methods: We identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references. Selection criteria: We included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care. Data collection and analysis: Two review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence. Main results: We included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events. For people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants). After an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22). Authors' conclusions: This review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.

The Cochrane database of systematic reviews · meta-analysis · 29 citationsread the source →

A Randomized Stepped Care Intervention Trial Targeting Posttraumatic Stress Disorder for Surgically Hospitalized Injury Survivors

In Brief Objective: To test the effectiveness of a stepped care intervention model targeting posttraumatic stress disorder (PTSD) symptoms after injury. Background: Few investigations have evaluated interventions for injured patients with PTSD and related impairments that can be feasibly implemented in trauma surgical settings. Methods: The investigation was a pragmatic effectiveness trial in which 207 acutely injured hospitalized trauma survivors were screened for high PTSD symptom levels and then randomized to a stepped combined care management, psychopharmacology, and cognitive behavioral psychotherapy intervention (n = 104) or usual care control (n = 103) conditions. The symptoms of PTSD and functional limitations were reassessed at 1, 3, 6, 9, and 12 months after the index injury admission. Results: Regression analyses demonstrated that over the course of the year after injury, intervention patients had significantly reduced PTSD symptoms when compared with controls [group by time effect, CAPS (Clinician-Administered PTSD Scale): F(2, 185) = 5.50, P < 0.01; PCL-C (PTSD Checklist Civilian Version): F(4, 185) = 5.45, P < 0.001]. Clinically and statistically significant PTSD treatment effects were observed at the 6-, 9-, and 12-month postinjury assessments. Over the course of the year after injury, intervention patients also demonstrated significant improvements in physical function [MOS SF-36 PCS (Medical Outcomes Study Short Form 36 Physical Component Summary) main effect: F(1, 172) = 9.87, P < 0.01]. Conclusions: Stepped care interventions can reduce PTSD symptoms and improve functioning over the course of the year after surgical injury hospitalization. Orchestrated investigative and policy efforts could systematically introduce and evaluate screening and intervention procedures for PTSD at US trauma centers. (Trial Registration: clinicaltrials.gov identifier: NCT00270959) Acutely injured surgically hospitalized trauma survivors were screened for high posttraumatic stress disorder (PTSD) symptom levels and then randomized to a stepped-care intervention (n = 104) or a usual-care intervention (n = 103). Intervention patients demonstrated clinically and statistically significant reductions in PTSD symptoms and improved physical function over the course of the year after injury. Orchestrated investigative and policy efforts could systematically introduce and evaluate screening and intervention procedures for PTSD at US trauma centers.

Annals of Surgery · randomised controlled trial · 229 citationsread the source →

Support for healthy breastfeeding mothers with healthy term babies.

Background: There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant's diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation. Objectives: 1. To describe types of breastfeeding support for healthy breastfeeding mothers with healthy term babies. 2. To examine the effectiveness of different types of breastfeeding support interventions in terms of whether they offered only breastfeeding support or breastfeeding support in combination with a wider maternal and child health intervention ('breastfeeding plus' support).  3. To examine the effectiveness of the following intervention characteristics on breastfeeding support:      a. type of support (e.g. face-to-face, telephone, digital technologies, group or individual support, proactive or reactive);      b. intensity of support (i.e. number of postnatal contacts);      c. person delivering the intervention (e.g. healthcare professional, lay person);     d. to examine whether the impact of support varied between high- and low-and middle-income countries. Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes results of searches of CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP)) (11 May 2021) and reference lists of retrieved studies. Selection criteria: Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Support could be provided face-to-face, over the phone or via digital technologies. All studies had to meet the trustworthiness criteria.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed risk of bias and study trustworthiness.  The certainty of the evidence was assessed using the GRADE approach. Main results: This updated review includes 116 trials of which 103 contribute data to the analyses. In total more than 98,816 mother-infant pairs were included.  Moderate-certainty evidence indicated that 'breastfeeding only' support probably reduced the number of women stopping breastfeeding for all primary outcomes: stopping any breastfeeding at six months (Risk Ratio (RR) 0.93, 95% Confidence Interval (CI) 0.89 to 0.97); stopping exclusive breastfeeding at six months (RR 0.90, 95% CI 0.88 to 0.93); stopping any breastfeeding at 4-6 weeks (RR 0.88, 95% CI 0.79 to 0.97); and stopping exclusive breastfeeding at 4-6 (RR 0.83 95% CI 0.76 to 0.90). Similar findings were reported for the secondary breastfeeding outcomes except for any breastfeeding at two months and 12 months when the evidence was uncertain if 'breastfeeding only' support helped reduce the number of women stopping breastfeeding.  The evidence for 'breastfeeding plus' was less consistent. For primary outcomes there was some evidence that 'breastfeeding plus' support probably reduced the number of women stopping any breastfeeding (RR 0.94, 95% CI 0.91 to 0.97, moderate-certainty evidence) or exclusive breastfeeding at six months (RR 0.79, 95% CI 0.70 to 0.90).  'Breastfeeding plus' interventions may have a beneficial effect on reducing the number of women stopping exclusive breastfeeding at 4-6 weeks, but the evidence is very uncertain (RR 0.73, 95% CI 0.57 to 0.95). The evidence suggests that 'breastfeeding plus' support probably results in little to no difference in the number of women stopping any breastfeeding at 4-6 weeks (RR 0.94, 95% CI 0.82 to 1.08, moderate-certainty evidence). For the secondary outcomes, it was uncertain if 'breastfeeding plus' support helped reduce the number of women stopping any or exclusive breastfeeding at any time points.  There were no consistent findings emerging from the narrative synthesis of the non-breastfeeding outcomes (maternal satisfaction with care, maternal satisfaction with feeding method, infant morbidity, and maternal mental health), except for a possible reduction of diarrhoea in intervention infants.  We considered the overall risk of bias of trials included in the review was mixed. Blinding of participants and personnel is not feasible in such interventions and as studies utilised self-report breastfeeding data, there is also a risk of bias in outcome assessment.   We conducted meta-regression to explore substantial heterogeneity for the primary outcomes using the following categories: person providing care; mode of delivery; intensity of support; and income status of country.  It is possible that moderate levels (defined as 4-8 visits) of 'breastfeeding only' support may be associated with a more beneficial effect on exclusive breastfeeding at 4-6 weeks and six months. 'Breastfeeding only' support may also be more effective in reducing women in low- and middle-income countries (LMICs) stopping exclusive breastfeeding at six months compared to women in high-income countries (HICs). However, no other differential effects were found and thus heterogeneity remains largely unexplained. The meta-regression suggested that there were no differential effects regarding person providing support or mode of delivery, however, power was limited.  AUTHORS' CONCLUSIONS: When 'breastfeeding only' support is offered to women, the duration and in particular, the exclusivity of breastfeeding is likely to be increased. Support may also be more effective in reducing the number of women stopping breastfeeding at three to four months compared to later time points.  For 'breastfeeding plus' interventions the evidence is less certain. Support may be offered either by professional or lay/peer supporters, or a combination of both. Support can also be offered face-to-face, via telephone or digital technologies, or a combination and may be more effective when delivered on a schedule of four to eight visits. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

The Cochrane database of systematic reviews · systematic review · 92 citationsread the source →

Effectiveness and sustainability of the ViSC Social Competence Program to prevent cyberbullying and cyber-victimization: Class and individual level moderators.

We investigated whether the general anti-bullying program ViSC sustainably prevents cyberbullying and cyber-victimization. A longitudinal randomized control group design was used to examine (i) program effectiveness immediately after a 1 year implementation phase and (ii) sustainable program effects 6 months later taking several moderators on the class level (class climate and ethnic diversity) and on the individual level (gender, age, internet usage, traditional bullying/victimization) into account. Effectiveness (e.g., the change between waves 2 and 1) was examined in 2,042 students (47.6% girls), aged 11.7 years (SD = 0.88) enrolled in 18 schools and 103 classes. Sustainability (e.g., the change between waves 3 and 2) was examined in a sub-sample of 6 schools and 35 classes comprising 659 students. The self-assessment multiple-item scales showed longitudinal and multiple group invariance. Factor scores were extracted to compute difference scores for effectiveness (Posttest minus Pretest) and sustainability (Follow-up test minus Posttest) for cyberbullying and cyber-victimization. Multilevel Modeling was applied to examine (i) the effectiveness and (ii) the sustainability of the ViSC intervention controlling for several individual and class level variables. Controlling for covariates, it was demonstrated that the ViSC program is effective in preventing cyberbullying and cyber-victimization and that the effects are sustainable after 6 months. The consequences for cyberbullying prevention are discussed.

Aggressive behavior · randomised controlled trial · 26 citationsread the source →

Family-focused therapy for individuals at clinical high risk for psychosis: treatment fidelity within a multisite randomized trial.

Aim: Family psychoeducation is an effective adjunct to pharmacotherapy in delaying relapse among patients with schizophrenia and bipolar disorder. This study tested the treatment adherence and competence of newly trained clinicians to an adaptation of family-focused therapy for individuals at clinical high risk for psychosis (FFT-CHR). Methods: The sample included 103 youth or young adults (ages 12-30 years) who had attenuated positive symptoms of psychosis. Families participated in a randomized trial comparing two psychosocial interventions: FFT-CHR (18 sessions over 6 months) and enhanced care (EC; 3 sessions over 1 month). Following a 1.5-day training seminar, 24 clinicians from eight study sites received teleconference supervision in both treatment protocols for the 2-year study period. Treatment fidelity was rated with the 13-item Therapy Competence and Adherence Scales, Revised. Results: Supervisors classified 90% of treatment sessions as above acceptable fidelity thresholds (ratings of 5 or better on a 1-7 scale of overall fidelity). As expected, fidelity ratings indicated that FFT-CHR included a greater emphasis on communication and problem-solving skills training than EC, but ratings of non-specific clinician skills, such as maintaining rapport and appropriately pacing sessions, did not differ between conditions. Treatment fidelity was not related to the severity of symptoms or family conflict at study entry. Conclusions: FFT-CHR can be administered with high levels of fidelity by clinicians who receive training and supervision. Future studies should examine whether there are more cost-effective methods for training, supervising and monitoring the fidelity of FFT-CHR.

Early intervention in psychiatry · randomised controlled trial · 28 citationsread the source →

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial.

Background: Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression. Methods: In this randomised, multicentre, non-inferiority clinical trial, we recruited patients who were referred to specialty neurostimulation centres based at three Canadian university hospitals (Centre for Addiction and Mental Health and Toronto Western Hospital, Toronto, ON, and University of British Columbia Hospital, Vancouver, BC). Participants were aged 18-65 years, were diagnosed with a current treatment-resistant major depressive episode or could not tolerate at least two antidepressants in the current episode, were receiving stable antidepressant medication doses for at least 4 weeks before baseline, and had an HRSD-17 score of at least 18. Participants were randomly allocated (1:1) to treatment groups (10 Hz rTMS or iTBS) by use of a random permuted block method, with stratification by site and number of adequate trials in which the antidepressants were unsuccessful. Treatment was delivered open-label but investigators and outcome assessors were masked to treatment groups. Participants were treated with 10 Hz rTMS or iTBS to the left dorsolateral prefrontal cortex, administered on 5 days a week for 4-6 weeks. The primary outcome measure was change in 17-item Hamilton Rating Scale for Depression (HRSD-17) score, with a non-inferiority margin of 2·25 points. For the primary outcome measure, we did a per-protocol analysis of all participants who were randomly allocated to groups and who attained the primary completion point of 4 weeks. This trial is registered with ClinicalTrials.gov, number NCT01887782. Findings: Between Sept 3, 2013, and Oct 3, 2016, we randomly allocated 205 participants to receive 10 Hz rTMS and 209 participants to receive iTBS. 192 (94%) participants in the 10 Hz rTMS group and 193 (92%) in the iTBS group were assessed for the primary outcome after 4-6 weeks of treatment. HRSD-17 scores improved from 23·5 (SD 4·4) to 13·4 (7·8) in the 10 Hz rTMS group and from 23·6 (4·3) to 13·4 (7·9) in the iTBS group (adjusted difference 0·103 [corrected], lower 95% CI -1·16; p=0·0011), which indicated non-inferiority of iTBS. Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011). Dropout rates did not differ between groups (10 Hz rTMS: 13 [6%] of 205 participants; iTBS: 16 [8%] of 209 participants); p=0·6004). The most common treatment-related adverse event was headache in both groups (10 Hz rTMS: 131 [64%] of 204; iTBS: 136 [65%] of 208). Interpretation: In patients with treatment-resistant depression, iTBS was non-inferior to 10 Hz rTMS for the treatment of depression. Both treatments had low numbers of dropouts and similar side-effects, safety, and tolerability profiles. By use of iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness. Funding: Canadian Institutes of Health Research.

Lancet (London, England) · randomised controlled trial · 938 citationsread the source →

Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial.

Aims and objectives: To explore the effects of a home care mobile app on the outcomes of stoma patients who discharged from hospital. Background: Patients with a newly formed stoma experience many difficulties after surgery. Mobile application (app) has the potential to help patients self-manage their diseases and adjust to the changes in their lives and is a convenient way to ensure the continuity of care. However, there is a lack of studies about the effects of a mobile app on the transitional care for improving discharged stoma-related health outcomes. Design: A randomised controlled trial. Methods: A total of 203 patients with a permanent stoma in tertiary hospitals in China were randomly assigned into two groups. Patients in the control group (n = 103) received routine discharge care. Patients in the intervention group (n = 100) received home care via a mobile app besides routine care. The psychosocial adjustment level, self-efficacy scale and stoma complications incidence were measured in the follow-up period and compared between the two groups. Data were collected at four time points: before intervention (baseline), at 1, 3 and 6 months after discharge. Results: The psychosocial adjustment level and stoma self-efficacy score of the intervention group were significantly higher than those of the control group, respectively, at 1-, 3- and 6-month follow-up (all p < 0.05). The incidence of stoma complications in the intervention group was tending to reduce at 1, 3 and 6 months after discharge. Conclusion: The findings indicated that follow-up care at home via a mobile app can effectively improve the psychosocial adjustment level, self-efficacy scale and other related outcomes of stoma patients. Relevance to clinical practice: The home care mobile app is an effective intervention to support the psychosocial adjustment and self-efficacy of stoma patients after discharge. It ensures the continuity of care and provides nursing guidance for the patients timely.

Journal of clinical nursing · randomised controlled trial · 54 citationsread the source →

Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial.

Background: Fatigue is one of the most disabling symptoms reported by people with multiple sclerosis. Although behavioural and pharmacological interventions might be partly beneficial, their combined effects have not been evaluated for multiple sclerosis fatigue, or examined with sufficient consideration of characteristics that might affect treatment response. In this comparative effectiveness research trial, we compared the effectiveness of cognitive behavioural therapy (CBT), modafinil, and their combination for treating multiple sclerosis fatigue. Methods: This randomised, analyst-blinded, parallel-arm, comparative effectiveness trial was done at two universities in the USA. Adults (aged ≥18 years) with multiple sclerosis and problematic fatigue (Fatigue Severity Scale [FSS] score ≥4) were randomly assigned (1:1:1), using a web-based treatment assignment system with minimisation, to receive CBT, modafinil, or both for 12 weeks. Statisticians were masked to group assignment, but participants, study neurologists, CBT interventionalists, and coordinators were not masked to treatment assignment. The primary outcome was the change in Modified Fatigue Impact Scale (MFIS) from baseline to 12 weeks, assessed using multiple linear regression, adjusted for age, sex, study site, anxiety, pain, baselines MFIS score, and physical activity. Analyses were done by intent to treat. The trial was registered with clinicaltrials.gov, NCT03621761, and is completed. Findings: Between Nov 15, 2018, and June 2, 2021, 336 participants were randomly assigned treatment (114 assigned to CBT, 114 assigned to modafinil, and 108 assigned to combination therapy). At 12 weeks, CBT (n=103), modafinil (n=107), and combination therapy (n=102) were associated with clinically meaningful within-group MFIS reductions of 15·20 (SD 11·90), 16·90 (15·90), and 17·30 (16·20) points, respectively. Change in MFIS scores from baseline to 12 weeks did not differ between groups: relative to combination therapy, the adjusted total mean difference in MFIS change score was 1·88 (95% CI -2·21 to 5·96) for CBT and 1·20 (-2·83 to 5·23) for modafinil. Most common adverse events for modafinil-containing treatment groups included insomnia (eight [7%] for modafinil and eight [7%] for combination therapy) and anxiety (three [3%] for modafinil and nine [8%] for combination therapy). Interpretation: Modafinil, CBT, and combination therapy were associated with similar reductions in the effects of multiple sclerosis fatigue at 12 weeks. Combination therapy was not associated with augmented improvement compared with the individual interventions. Further research is needed to determine whether effects of these interventions on multiple sclerosis-related fatigue is influenced by sleep hygiene and sleepiness. No serious adverse events related to the study drug were encountered. Funding: Patient-Centered Outcomes Research Institute and National Multiple Sclerosis Society.

The Lancet. Neurology · randomised controlled trial · 6 citationsread the source →

Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial.

Background: No large trials have been done to investigate the efficacy of an intervention combining a specific compound and several lifestyle interventions compared with placebo for the prevention of cognitive decline. We tested the effect of omega 3 polyunsaturated fatty acid supplementation and a multidomain intervention (physical activity, cognitive training, and nutritional advice), alone or in combination, compared with placebo, on cognitive decline. Methods: The Multidomain Alzheimer Preventive Trial was a 3-year, multicentre, randomised, placebo-controlled superiority trial with four parallel groups at 13 memory centres in France and Monaco. Participants were non-demented, aged 70 years or older, and community-dwelling, and had either relayed a spontaneous memory complaint to their physician, limitations in one instrumental activity of daily living, or slow gait speed. They were randomly assigned (1:1:1:1) to either the multidomain intervention (43 group sessions integrating cognitive training, physical activity, and nutrition, and three preventive consultations) plus omega 3 polyunsaturated fatty acids (ie, two capsules a day providing a total daily dose of 800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid), the multidomain intervention plus placebo, omega 3 polyunsaturated fatty acids alone, or placebo alone. A computer-generated randomisation procedure was used to stratify patients by centre. All participants and study staff were blinded to polyunsaturated fatty acid or placebo assignment, but were unblinded to the multidomain intervention component. Assessment of cognitive outcomes was done by independent neuropsychologists blinded to group assignment. The primary outcome was change from baseline to 36 months on a composite Z score combining four cognitive tests (free and total recall of the Free and Cued Selective Reminding test, ten Mini-Mental State Examination orientation items, Digit Symbol Substitution Test, and Category Naming Test) in the modified intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT00672685). Findings: 1680 participants were enrolled and randomly allocated between May 30, 2008, and Feb 24, 2011. In the modified intention-to-treat population (n=1525), there were no significant differences in 3-year cognitive decline between any of the three intervention groups and the placebo group. Between-group differences compared with placebo were 0·093 (95% CI 0·001 to 0·184; adjusted p=0·142) for the combined intervention group, 0·079 (-0·012 to 0·170; 0·179) for the multidomain intervention plus placebo group, and 0·011 (-0·081 to 0·103; 0·812) for the omega 3 polyunsaturated fatty acids group. 146 (36%) participants in the multidomain plus polyunsaturated fatty acids group, 142 (34%) in the multidomain plus placebo group, 134 (33%) in the polyunsaturated fatty acids group, and 133 (32%) in the placebo group had at least one serious emerging adverse event. Four treatment-related deaths were recorded (two in the multidomain plus placebo group and two in the placebo group). The interventions did not raise any safety concerns and there were no differences between groups in serious or other adverse events. Interpretation: The multidomain intervention and polyunsaturated fatty acids, either alone or in combination, had no significant effects on cognitive decline over 3 years in elderly people with memory complaints. An effective multidomain intervention strategy to prevent or delay cognitive impairment and the target population remain to be determined, particularly in real-world settings. Funding: French Ministry of Health, Pierre Fabre Research Institute, Gerontopole, Exhonit Therapeutics, Avid Radiopharmaceuticals.

The Lancet. Neurology · randomised controlled trial · 632 citationsread the source →

'Tell Your Story': a randomized controlled trial of an online intervention to reduce mental health stigma and increase help-seeking in refugee men with posttraumatic stress.

Background: Refugees report elevated rates of posttraumatic stress disorder (PTSD), but are relatively unlikely to seek help for their symptoms. Mental health stigma is a key barrier to help-seeking amongst refugees. We evaluated the efficacy of an online intervention in reducing self-stigma and increasing help-seeking in refugee men. Methods: Participants were 103 refugee men with PTSD symptoms from Arabic, Farsi or Tamil-speaking backgrounds who were randomly assigned to either receive an 11-module online stigma reduction intervention specifically designed for refugees ('Tell Your Story', TYS) or to a wait-list control (WLC) group. Participants completed online assessments of self-stigma for PTSD and help-seeking, and help-seeking intentions and behaviors at baseline, post-intervention, and at a 1 month follow-up. Results: Intent-to-treat analyses indicated that, compared to the WLC, TYS resulted in significantly smaller increases in self-stigma for seeking help from post-treatment to follow-up (d = 0.42, p = 0.008). Further, participants in the TYS conditions showed greater help-seeking behavior from new sources at follow-up (B = 0.69, 95% CI 0.19-1.18, p = 0.007) than those in the WLC. The WLC showed significantly greater increases in help-seeking intentions from post-intervention to follow-up (d = 0.27, p = 0.027), relative to the TYS group. Conclusions: This is the first investigation of a mental health stigma reduction program specifically designed for refugees. Findings suggest that evidence-based stigma reduction strategies are beneficial in targeting self-stigma related to help-seeking and increasing help-seeking amongst refugees. These results indicate that online interventions focusing on social contact may be a promising avenue for removing barriers to accessing help for mental health symptoms in traumatized refugees.

Psychological medicine · randomised controlled trial · 44 citationsread the source →

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial.

Objective: We compared mindfulness-based cognitive therapy (MBCT) with both cognitive psychological education (CPE) and treatment as usual (TAU) in preventing relapse to major depressive disorder (MDD) in people currently in remission following at least 3 previous episodes. Method: A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU, CPE plus TAU, and TAU alone, and data were analyzed for the 255 (93%; MBCT = 99, CPE = 103, TAU = 53) retained to follow-up. MBCT was delivered in accordance with its published manual, modified to address suicidal cognitions; CPE was modeled on MBCT, but without training in meditation. Both treatments were delivered through 8 weekly classes. Results: Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up, hazard ratio for MBCT vs. CPE = 0.88, 95% CI [0.58, 1.35]; for MBCT vs. TAU = 0.69, 95% CI [0.42, 1.12]. However, severity of childhood trauma affected relapse, hazard ratio for increase of 1 standard deviation = 1.26 (95% CI [1.05, 1.50]), and significantly interacted with allocated treatment. Among participants above median severity, the hazard ratio was 0.61, 95% CI [0.34, 1.09], for MBCT vs. CPE, and 0.43, 95% CI [0.22, 0.87], for MBCT vs. TAU. For those below median severity, there were no such differences between treatment groups. Conclusion: MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma, but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression.

Journal of consulting and clinical psychology · randomised controlled trial · 215 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 →

Integrated Exposure-Based Therapy for Co-occurring Posttraumatic Stress Disorder and Substance Dependence

CONTEXT: There is concern that exposure therapy, an evidence-based cognitive-behavioral treatment for posttraumatic stress disorder (PTSD), may be inappropriate because of risk of relapse for patients with co-occurring substance dependence. OBJECTIVE: To determine whether an integrated treatment for PTSD and substance dependence, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), can achieve greater reductions in PTSD and substance dependence symptom severity compared with usual treatment for substance dependence. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial enrolling 103 participants who met DSM-IV-TR criteria for both PTSD and substance dependence. Participants were recruited from 2007-2009 in Sydney, Australia; outcomes were assessed at 9 months postbaseline, with interim measures collected at 6 weeks and 3 months postbaseline. INTERVENTIONS: Participants were randomized to receive COPE plus usual treatment (n = 55) or usual treatment alone (control) (n = 48). COPE consists of 13 individual 90-minute sessions (ie, 19.5 hours) with a clinical psychologist. MAIN OUTCOME MEASURES: Change in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS; scale range, 0-240) and change in severity of substance dependence as measured by the number of dependence criteria met according to the Composite International Diagnostic Interview version 3.0 (CIDI; range, 0-7), from baseline to 9-month follow-up. A change of 15 points on the CAPS scale and 1 dependence criterion on the CIDI were considered clinically significant. RESULTS: From baseline to 9-month follow-up, significant reductions in PTSD symptom severity were found for both the treatment group (mean difference, -38.24 [95% CI, -47.93 to -28.54]) and the control group (mean difference, -22.14 [95% CI, -30.33 to -13.95]); however, the treatment group demonstrated a significantly greater reduction in PTSD symptom severity (mean difference, -16.09 [95% CI, -29.00 to -3.19]). No significant between-group difference was found in relation to improvement in severity of substance dependence (0.43 vs 0.52; incidence rate ratio, 0.85 [95% CI, 0.60 to 1.21), nor were there any significant between-group differences in relation to changes in substance use, depression, or anxiety. CONCLUSION: Among patients with PTSD and substance dependence, the combined use of COPE plus usual treatment, compared with usual treatment alone, resulted in improvement in PTSD symptom severity without an increase in severity of substance dependence. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN12908171.

JAMA · randomised controlled trial · 330 citationsread the source →

The contributions of social comparison to social network site addiction.

Excessive use of social network sites (SNSs) can often lead to negative consequences of frequent upward social comparisons despite having the social network platform to present users in a favorable light. However, the existing literature gives little evidence to social comparison related antecedents and consequents of uncontrollable use of SNSs. The present study aimed to investigate the contributions of social comparison to SNS addiction. In Study 1, using a convenient sample in Austria (n = 103), we showed that the tendency to engage in social comparisons of ability (but not of opinion) predicted self-reported SNS addiction over and above the feelings of relative deprivation on social support and status. SNS addiction mediated the relations between social comparison of ability and stress, but not self-esteem. In Study 2, using a broad sample of participants in Austria (n = 500), we replicated the findings observed in Study 1 and showed that contrastive upward social comparison emotions (i.e., envy, depression) mediated the relation between SNS addiction and lower self-esteem whereas the contrastive downward social comparison emotion (i.e., contentment) mediated the relation between SNS addiction and higher self-esteem. Our findings suggest that SNS addiction closely relates to psychological constructs relevant to social comparison, mediates the link between social comparison of ability and detrimental consequences (i.e., stress, well-being) and demonstrate how social comparison emotions relate to both positive and negative associations between SNS addiction and self-esteem.

PloS one · 14 citationsread the source →

Cognitive Behavior Therapy Versus Other Psychosocial Treatments for Schizophrenia

Cognitive behavioral therapy (CBT) is now a recommended treatment for people with schizophrenia. In CBT, links are made between the person’s feelings and patterns of thinking that underpin their distress. At present, a variety of interventions have been labeled as CBT and it is difficult to provide a single, unambiguous definition. In recognition, the review authors have constructed criteria that are felt to be both workable and to capture the elements of good practice in CBT. Cognitive behavioral therapy is becoming increasingly available for people with schizophrenia, with recent recommendations of treatment guidelines in, for example, the United Kingdom suggesting that CBT should be more widely available for people with schizophrenia. It should be noted that many of the trials of CBT for psychosis have incorporated additional active therapeutic elements (eg, psychoeducation and relapse prevention) that would be considered adjunctive to techniques that are specifically targeted at eliciting belief change (eg, guided discovery or behavioral experiments). The comparison arm of the trials reported other psychosocial therapies, such as supportive therapy, psychoeducation, family therapy, and other “talking therapies.” The full review distinguishes between trials that described “active” psychosocial interventions (eg, family therapy) aimed at a meaningful symptom reduction and those trials that have used “nonactive” psychosocial interventions (eg, supportive therapy), which act as merely a control for the nonspecific effects of therapy (eg, time spent with therapist). Outcomes are presented separately for active and nonactive psychosocial interventions and the pooled effect of these trials is also presented. We searched the Cochrane Schizophrenia Group Trials Register (March 2010) that is based on regular searches of CINAHL, EMBASE, MEDLINE, and PsycINFO. We inspected all references of the selected articles for further relevant trials, and, where appropriate, contacted authors. All relevant randomized controlled trials of CBT for people with schizophrenia-like illnesses. Studies were reliably selected and assessed for methodological quality. Two review authors, working independently, extracted data. We analyzed dichotomous data on an intention-to-treat basis and continuous data with 65% completion rate are presented. Where possible, for dichotomous outcomes, we estimated a risk ratio (RR) with the 95% confidence interval (CI) along with the number needed to treat/harm. Thirty articles described 20 trials. Trials were often small and of limited quality. In figure 1 the various risks of bias are presented as percentages across all included studies. Risk of bias chart. The main findings of this review are summarized in table 1. When CBT was compared with other psychosocial therapies, no difference was found for outcomes relevant to adverse effect/events (2 RCTs, n = 202, RR death 0.57 CI 0.12–2.60). Relapse was not either reduced over any time period (5 RCTs, n = 183, RR long term 0.91 CI 0.63–1.32) nor was rehospitalization (5 RCTs, n = 294, RR in longer term 0.86 CI 0.62–1.21). Various global mental state measures failed to show difference (4 RCTs, n = 244, RR no important change in mental state 0.84 CI 0.64–1.09). More specific measures of mental state failed to show differential effects on positive or negative symptoms of schizophrenia, but there may be some long-term effect for affective symptoms (2 RCTs, n = 105, mean difference (MD) Beck Depression Inventory (BDI) −6.21 CI −10.81 to −1.61). Few trials report on social functioning or quality of life. Findings do not convincingly favor either of the interventions (2 RCTs, n = 103, MD Social Functioning Scale (SFS) 1.32 CI −4.90 to 7.54; n = 37, MD EuroQOL −1.86 CI −19.20 to 15.48). For the outcome of leaving the study early, we found no significant advantage when CBT was compared with either nonactive control therapies (4 RCTs, n = 433, RR 0.88 CI 0.63–1.23) or active therapies (6 RCTs, n = 339, RR 0.75 CI 0.40–1.43). Summary of Findings a The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Medium risk: roughly equates with that of the trial control groups. 2Limitation in design—rated “serious”: studies short, randomization poorly described, blinding at outcome—single at best and untested. 3Imprecision—rated “serious”: one small study. 4Imprecision—rated “serious”: no other studies made any report of adverse effects. 5Publication bias: rated “likely”: all trials were small—searches may fail to identify other small less positive trials. 6Long term: defined as over 1 year. 7Indirectness—rated “serious”: various measures used with differing criteria. 8Indirectness—rated “serious”: scale derived data—not “employment” as stated in protocol. Summary of Findings a The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Medium risk: roughly equates with that of the trial control groups. 2Limitation in design—rated “serious”: studies short, randomization poorly described, blinding at outcome—single at best and untested. 3Imprecision—rated “serious”: one small study. 4Imprecision—rated “serious”: no other studies made any report of adverse effects. 5Publication bias: rated “likely”: all trials were small—searches may fail to identify other small less positive trials. 6Long term: defined as over 1 year. 7Indirectness—rated “serious”: various measures used with differing criteria. 8Indirectness—rated “serious”: scale derived data—not “employment” as stated in protocol. The use of CBT has been associated with some reduction in symptoms, particularly affective problems associated with having such a serious illness. However, there is considerable variability in the findings of the various studies and, at present, it is not possible to assert any substantial benefit for cognitive behavioral therapy over other psychological therapies. Full details are published in the Cochrane Review (Jones, 2012).

Schizophrenia Bulletin · cohort or longitudinal · 173 citationsread the source →

Exposure to parental and community violence and the relationship to bullying perpetration and victimization among early adolescents: A parallel process growth mixture latent transition analysis.

This study examined heterogeneity in parental and community violence exposure during middle school and its association with bullying perpetration and victimization in high school. Youth (N = 1,611) in four Midwestern middle schools participated. Parallel process growth mixture latent transition analysis was used to understand how trajectory profiles of middle school violence exposure was associated with high school bullying profiles. Impulsivity, depression, school belonging, and delinquency were assessed as moderators of the transition probabilities. A three class solution was found for violence exposure: decreasing parental violence/increasing community violence (n = 103; 6.4%), stable high parental violence and low community violence (n = 1,027; 63.7%), and increasing parental violence and stable high community violence (n = 481; 29.8%). Similarly, a three class solution was found for high school bullying: High Bullying Perpetration and High Victimization class (n = 259; 16%), Victimization only (n = 1145; 71%), and low all class (n = 207; 13%). The largest proportion of youth transitioning into the high bullying and high victimization class were from the decreasing parental violence/increasing community violence. Depression, impulsivity, school belonging, and delinquency all had various moderating effects on transition probabilities. Our findings make it apparent that early forms of parental and community violence are associated with aggressive behaviors and experiences with victimization during high school. Prevention and intervention efforts should target individuals who display early and chronic patterns of exposure to violence as these individuals have the greatest risk of later aggressive and victimization in high school.

Scandinavian journal of psychology · 34 citationsread the source →

Randomized controlled trial of once-per-week intermittent fasting for health improvement: the WONDERFUL trial.

Aims: Low-density lipoprotein cholesterol (LDL-C) predicts heart disease onset and may be reduced by intermittent fasting. Some studies, though, reported that fasting increased LDL-C; however, no study evaluated LDL-C as the primary endpoint. This randomized controlled trial evaluated the effect of low-frequency intermittent fasting on LDL-C and other biomarkers. Methods and results: Adults aged 21-70 years were enrolled who were not taking a statin, had modestly elevated LDL-C, had ≥1 metabolic syndrome feature or type 2 diabetes, and were not taking anti-diabetic medication (N = 103). Water-only 24-h fasting was performed twice weekly for 4 weeks and then once weekly for 22 weeks; controls ate ad libitum. The primary outcome was 26-week LDL-C change score. Secondary outcomes (requiring P ≤ 0.01) were 26-week changes in homeostatic model assessment of insulin resistance (HOMA-IR), Metabolic Syndrome Score (MSS), brain-derived neurotrophic factor (BDNF), and MicroCog general cognitive proficiency index (GCPi). Intermittent fasting (n = 50) and control (n = 53) subjects were, respectively, aged 49.3 ± 12.0 and 47.0 ± 9.8 years, predominantly female (66.0% and 67.9%), and overweight (103 ± 24 and 100 ± 21 kg) and had modest LDL-C elevation (124 ± 19 and 128 ± 20 mg/dL). Drop-outs (n = 12 fasting, n = 20 control) provided an evaluable sample of n = 71 (n = 38 fasting, n = 33 control). Intermittent fasting did not change LDL-C (0.2 ± 16.7 mg/dL) vs. control (2.5 ± 19.4 mg/dL; P = 0.59), but it improved HOMA-IR (-0.75 ± 0.79 vs. -0.10 ± 1.06; P = 0.004) and MSS (-0.34 ± 4.72 vs. 0.31 ± 1.98, P = 0.006). BDNF (P = 0.58), GCPi (P = 0.17), and weight (-1.7 ± 4.7 kg vs. 0.2 ± 3.5 kg, P = 0.06) were unchanged. Conclusions: A low-frequency intermittent fasting regimen did not reduce LDL-C or improve cognitive function but significantly reduced both HOMA-IR and MSS. Trial registration: clinicaltrials.gov, NCT02770313.

European heart journal open · 30 citationsread the source →

Association of neighbourhood migrant density and risk of non-affective psychosis: a national, longitudinal cohort study.

Background: Elevated risk of psychotic disorders in migrant groups is a public mental health priority. We investigated whether living in areas of high own-region migrant density was associated with reduced risk of psychotic disorders among migrants and their children, and whether generation status, probable visible minority status, or region-of-origin affected this relationship. Methods: We used the Swedish registers to identify migrants and their children born between Jan 1, 1982, and Dec 31, 1996, and living in Sweden on or after their 15th birthday. We tracked all included participants from age 15 years or date of migration until emigration, death, or study end (Dec 31, 2016). The outcome was an ICD-10 diagnosis of non-affective psychosis (F20-29). We calculated own-region and generation-specific own-region density within the 9208 small areas for market statistics neighbourhoods in Sweden, and estimated the relationship between density and diagnosis of non-affective psychotic disorders using multilevel Cox proportional hazards models, adjusting for individual confounders (generation status, age, sex, calendar year, lone dwelling, and time since migration [migrants only]), family confounders (family income, family unemployment, and social welfare), and neighbourhood confounders (deprivation index, population density, and proportion of lone dwellings), and using the Akaike information criterion (AIC) to compare model fit. Findings: Of 468 223 individuals included in the final cohort, 4582 (1·0%) had non-affective psychotic disorder. Lower own-region migrant density was associated with increased risk of psychotic disorders among migrants (hazard ratio [HR] 1·05, 95% CI 1·02-1·07 per 5% decrease) and children of migrants (1·03, 1·01-1·06), after adjustment. These effects were stronger for probable visible minority migrants (1·07, 1·04-1·11), including migrants from Asia (1·42, 1·15-1·76) and sub-Saharan Africa (1·28, 1·15-1·44), but not migrants from probable non-visible minority backgrounds (0·99, 0·94-1·04). Among migrants, adding generation status to the measure of own-region density provided a better fit to the data than overall own-region migrant density (AIC 36 103 vs 36 106, respectively), with a 5% decrease in generation-specific migrant density corresponding to a HR of 1·07 (1·04-1·11). Interpretation: Migrant density was associated with non-affective psychosis risk in migrants and their children. Stronger protective effects of migrant density were found for probable visible minority migrants and migrants from Asia and sub-Saharan Africa. For migrants, this risk intersected with generation status. Together, these results suggest that this health inequality is socially constructed. Funding: Wellcome Trust, Royal Society, Mental Health Research UK, University College London, National Institute for Health Research, Swedish Research Council, and FORTE.

The lancet. Psychiatry · 30 citationsread the source →

A Qualitative Study Exploring Barriers and Facilitators of Enrolling Underrepresented Populations in Clinical Trials and Biobanking.

Disparities exist in enrollment in clinical trials and biorepositories among adults with low socioeconomic status, racial and ethnic minority groups and individuals who live in rural areas. Diverse participation is necessary to identify the most effective treatments in different groups. The purpose of this study was to use qualitative methods to identify factors that may affect the likelihood that members of underrepresented groups choose to participate in clinical trials and/or biobanking. We conducted 14 focus groups and seven telephone interviews in urban and rural areas of Louisiana to: (1) identify barriers and facilitators to participation; and (2) elicit input in crafting clear, culturally appropriate language and recruitment strategies. Of 103 participants, 25 were safety-net healthcare providers, 18 were primary care or oncology clinic patients, and 60 were members of social and faith-based groups. Patients and community participants were English-speaking, 79% were African American, 81% were female and 24% lived in rural areas. Barriers to participation identified were lack of knowledge about clinical trials and biobanks; limited specific information and access to participation, trust and privacy concerns about clinical trials and biobanking Facilitators included: altruism, high interest in medical research particularly studies that might benefit them or their families; plain language, culturally appropriate information; convenient access to studies; and input of a trusted provider. In addition, all primary care providers were interested in having clinical trial options available for their patients but did not have time to search for available trials. Results of this study can inform the development of education materials and strategies to increase participation of underrepresented groups in clinical trial and biobanking.

Frontiers in cell and developmental biology · 106 citationsread the source →

Moral decision making in adolescents: The effects of peer attachment, interpersonal affect, and gender.

Introduction: Sacrificial moral dilemmas are a useful tool for understanding how individuals reconcile concerns for aggregate welfare with the emotional aversion to deliberately, personally harming others. Yet little is known about how adolescents respond to such dilemmas, even though adolescence is a crucial period for moral development. The present study sought to investigate how adolescents respond to such dilemmas, with a focus on gender differences, age differences, and the role of two individual differences factors: peer attachment and dampened interpersonal affect. Methods: For this cross-sectional study, 103 adolescents (mean age = 14.5, SD = 0.81, range = 12-16; 54% girls; 41% Black, 24% White, 15% multiracial, 9% Hispanic/Latin, 3% Other, 2% Asian/Pacific Islander, 1% Native American, 5% no response) were recruited from the local community (Brooklyn, NY, USA). Adolescents responded to a series of sacrificial moral dilemmas. Then, participants and their caregivers completed questionnaires to assess adolescents' callous-unemotional traits (e.g., lack of empathy) and the quality of their peer relationships. Results: On average, participants endorsed committing personal harm for the greater good in 53% of their responses. Girls endorsed personal utilitarian sacrifice more than boys. Peer attachment, but not dampened interpersonal affect, was associated with increased endorsement of personal utilitarian sacrifice. Age and responses to dilemmas were not associated. Conclusions: Our results suggest that peer relationships are an important part of adolescent moral decision-making, for girls in particular. Our results also indicate that adolescents' utilitarian responses to conventional sacrificial moral dilemmas do not reflect a decreased aversion to interpersonal harm.

Journal of adolescence · 2 citationsread the source →

Prospective associations of the infant gut microbiome and microbial function with social behaviors related to autism at age 3 years.

The hypothesized link between gut bacteria and autism spectrum disorder (ASD) has been explored through animal models and human studies with microbiome assessment after ASD presentation. We aimed to prospectively characterize the association between the infant/toddler gut microbiome and ASD-related social behaviors at age 3 years. As part of an ongoing birth cohort gut bacterial diversity, structure, taxa, and function at 6 weeks (n = 166), 1 year (n = 158), 2 years (n = 129), and 3 years (n = 140) were quantified with 16S rRNA gene and shotgun metagenomic sequencing (n = 101 six weeks, n = 103 one year). ASD-related social behavior was assessed at age 3 years using Social Responsiveness Scale (SRS-2) T-scores. Covariate-adjusted linear and permutation-based models were implemented. Microbiome structure at 1 year was associated with SRS-2 total T-scores (p = 0.01). Several taxa at 1, 2, and 3 years were associated with SRS-2 performance, including many in the Lachnospiraceae family. Higher relative abundance of Adlercreutzia equolifaciens and Ruminococcus torques at 1 year related to poorer SRS-2 performance. Two functional pathways, L-ornithine and vitamin B6 biosynthesis, were associated with better social skills at 3 years. Our results support potential associations between early-childhood gut microbiome and social behaviors. Future mechanistic studies are warranted to pinpoint sensitive targets for intervention.

Scientific reports · 43 citationsread the source →

Compassion for others, self-compassion, quality of life and mental well-being measures and their association with compassion fatigue and burnout in student midwives: A quantitative survey.

Background: compassion fatigue and burnout can impact on the performance of midwives, with this quantitative paper exploring the relationship between self-compassion, burnout, compassion fatigue, self-judgement, self-kindness, compassion for others, professional quality of life and well-being of student midwives. Method: a quantitative survey measured relationships using questionnaires: (1) Professional Quality of Life Scale; (2) Self-Compassion Scale; (3) Short Warwick and Edinburgh Mental Well-being Scale; (4) Compassion For Others Scale. Participants: a purposive and convenience sample of student midwives (n=103) studying at university participated in the study. Results: just over half of the sample reported above average scores for burnout. The results indicate that student midwives who report higher scores on the self-judgement sub-scale are less compassionate towards both themselves and others, have reduced well-being, and report greater burnout and compassion fatigue. Student midwives who report high on measures of self-compassion and well-being report less compassion fatigue and burnout. Conclusion: student midwives may find benefit from 'being kinder to self' in times of suffering, which could potentially help them to prepare for the emotional demands of practice and study. Implications: developing, creating and cultivating environments that foster compassionate care for self and others may play a significant role in helping midwives face the rigours of education and clinical practice during their degree programme.

Midwifery · 91 citationsread the source →

The prevalence and risk factors for postpartum depression symptoms of fathers at one and 6 months postpartum: an adjunct study of the Japan Environment & Children's Study.

Objective: To survey prevalence and risk factors for paternal postpartum depression symptoms at one and 6 months postpartum in Japan. Material and methods: The study participants enrolled in the prospective birth cohort study of an adjunct study of the Japan Environment and Children's Study. Postpartum depression symptoms were evaluated using the Japanese version of the Edinburgh Postnatal Depression Scale (EPDS-J). The cut-off scores on the paternal EPDS-J were eight and on maternal EPDS-J was nine, respectively. The multivariate logistic regression included an adjustment for paternal age, maternal age, the number of children in the family, family structure, paternal employment, paternal academic history, household income, paternal smoking status, paternal history of mental health disorders, the Kessler 6-item psychological distress scale (K6) score during pregnancy, infertility treatment, paternal mental intimate partner violence (IPV) during pregnancy, paternal physical IPV during pregnancy, the sex of the newborn, congenital anomalies of the newborn, infant disease under medical treatment, returning to the maternal parent's house to give birth or take care of infant, the father's history of disease or injury that required medical treatment, paternity leave, and the EPDS-J for mothers. Results: A total of 1023 and 1330 fathers and their spouse who had a single delivery were assessed at one and 6 months postpartum, respectively. The prevalence of paternal EPDS-J scores ≥8 was 11.2 and 12.0% at one and 6 months postpartum, respectively. In the multiple logistics analysis, paternal EPDS-J scores ≥8 at 1 month postpartum was significantly associated with history of mental health disorders (adjusted odds ratio (AOR) 2.825; 95% confidence interval (CI): 1.047-7.623), K6 score ≥13 during pregnancy (AOR 4.116; 95% CI: 1.598-10.599), household income <4000 × 103 yen (AOR 1.799; 95% CI: 1.072-3.021), and infant disease under medical treatment (AOR 1.720; 95% CI: 1.015-2.915). Paternal EPDS-J scores ≥8 at 6 months postpartum was significantly associated with K6 scores ≥13 during pregnancy (AOR 4.621; 95% CI: 2.113-10.107), unemployment (AOR 3.751; 95% CI: 1.739-8.091) and maternal EPDS-J scores ≥9 (AOR 2.460; 95% CI: 1.514-3.996).Conclusion: The prevalence of paternal postpartum depression symptoms were 11.2 and 12.0% at one and 6 months postpartum. Paternal postpartum depression symptoms at 1 month postpartum were associated with the history of mental health disorders, psychological distress during pregnancy, low income, and infant disease under medical treatment. Paternal postpartum depression symptoms at 6 months postpartum were associated with psychological distress during pregnancy, unemployment, and maternal postpartum depression. It is important to consider the paternal postpartum depression symptoms, and further enlightenment regarding these issues is recommended in Japan.

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 26 citationsread the source →

Socioeconomic and urban-rural differentials in exposure to air pollution and mortality burden in England.

Background: Socioeconomically disadvantaged populations often have higher exposures to particulate air pollution, which can be expected to contribute to differentials in life expectancy. We examined socioeconomic differentials in exposure and air pollution-related mortality relating to larger scale (5 km resolution) variations in background concentrations of selected pollutants across England. Methods: Ozone and particulate matter (sub-divided into PM10, PM2.5, PM2.5-10, primary, nitrate and sulphate PM2.5) were simulated at 5 km horizontal resolution using an atmospheric chemistry transport model (EMEP4UK). Annual mean concentrations of these pollutants were assigned to all 1,202,578 residential postcodes in England, which were classified by urban-rural status and socioeconomic deprivation based on the income and employment domains of the 2010 English Index of Multiple Deprivation for the Lower-level Super Output Area of residence. We used life table methods to estimate PM2.5-attributable life years (LYs) lost in both relative and absolute terms. Results: Concentrations of the most particulate fractions, but not of nitrate PM2.5 or ozone, were modestly higher in areas of greater socioeconomic deprivation. Relationships between pollution level and socioeconomic deprivation were non-linear and varied by urban-rural status. The pattern of PM2.5 concentrations made only a small contribution to the steep socioeconomic gradient in LYs lost due to PM2.5 per 103 population, which primarily was driven by the steep socioeconomic gradient in underlying mortality rates. In rural areas, the absolute burden of air pollution-related LYs lost was lowest in the most deprived deciles. Conclusions: Air pollution shows modest socioeconomic patterning at 5 km resolution in England, but absolute attributable mortality burdens are strongly related to area-level deprivation because of underlying mortality rates. Measures that cause a general reduction in background concentrations of air pollution may modestly help narrow socioeconomic differences in health.

Environmental health : a global access science source · 46 citationsread the source →

Hundred Days of Cognitive Training Enhance Broad Cognitive Abilities in Adulthood: Findings from the COGITO Study.

We examined whether positive transfer of cognitive training, which so far has been observed for individual tests only, also generalizes to cognitive abilities, thereby carrying greater promise for improving everyday intellectual competence in adulthood and old age. In the COGITO Study, 101 younger and 103 older adults practiced six tests of perceptual speed (PS), three tests of working memory (WM), and three tests of episodic memory (EM) for over 100 daily 1-h sessions. Transfer assessment included multiple tests of PS, WM, EM, and reasoning. In both age groups, reliable positive transfer was found not only for individual tests but also for cognitive abilities, represented as latent factors. Furthermore, the pattern of correlations between latent change factors of practiced and latent change factors of transfer tasks indicates systematic relations at the level of broad abilities, making the interpretation of effects as resulting from unspecific increases in motivation or self-concept less likely.

Frontiers in aging neuroscience · 201 citationsread the source →

Uncovering different masking factors on wrist skin temperature rhythm in free-living subjects.

Most circadian rhythms are controlled by a major pacemaker located in the hypothalamic suprachiasmatic nucleus. Some of these rhythms, called marker rhythms, serve to characterize the timing of the internal temporal order. However, these variables are susceptible to masking effects as the result of activity, body position, light exposure, environmental temperature and sleep. Recently, wrist skin temperature (WT) has been proposed as a new index for evaluating circadian system status. In light of previous evidence suggesting the important relationship between WT and core body temperature regulation, the aim of this work was to purify the WT pattern in order to obtain its endogenous rhythm with the application of multiple demasking procedures. To this end, 103 subjects (18-24 years old) were recruited and their WT, activity, body position, light exposure, environmental temperature and sleep were recorded under free-living conditions for 1 week. WT demasking by categories or intercepts was applied to simulate a "constant routine" protocol (awakening, dim light, recumbent position, low activity and warm environmental temperature). Although the overall circadian pattern of WT was similar regardless of the masking effects, its amplitude was the rhythmic parameter most affected by environmental conditions. The acrophase and mesor were determined to be the most robust parameters for characterizing this rhythm. In addition, a circadian modulation of the masking effect was found for each masking variable. WT rhythm exhibits a strong endogenous component, despite the existence of multiple external influences. This was evidenced by simultaneously eliminating the influence of activity, body position, light exposure, environmental temperature and sleep. We therefore propose that it could be considered a valuable and minimally-invasive means of recording circadian physiology in ambulatory conditions.

PloS one · 52 citationsread the source →

A longitudinal study of emotional intelligence training for otolaryngology residents and faculty.

Importance: Emotions underlie and influence physician communications and relationships with patients and colleagues. Training programs to enhance emotional attunement, or emotional intelligence (EI), for physicians and assess training effects are scarce. Objective: To assess whether an EI training program for otolaryngology residents and faculty affects patient satisfaction. Design, setting, and participants: Prospective longitudinal, cohort study of physician residents and faculty in an EI training program at the Department of Otolaryngology, University of Kansas Medical Center, with annual training from 2005 to 2011. Interventions: Three levels of interventions included 4 years of repeated EI assessment, 7 years of highly interactive EI training with high-risk/high-stress simulations, and ongoing modeling and mentoring of EI skills by faculty. Main outcomes and measures: Four levels of outcome of the EI training were assessed with the following questions: Did participants enjoy the program? Could they apply the training to their practice? Did it change their behavior? Did it affect patient satisfaction? The Emotional Quotient Inventory (EQ-i) was administered to faculty and residents, and the Press Ganey Patient Satisfaction Survey was completed by patients. Results: Ninety-seven percent of participants (103 of 106) reported that they enjoyed the programs, and 98% (104 of 106) reported that they have or could have applied what they learned. Participants demonstrated improvement in mean EQ-i scores from 102.19 (baseline/pretraining) to 107.29 (posttraining and assessment 1 year later; change, 6.71; 95% CI, 3.44-9.98). This increase was sustained in successive years, and these results were supported with linear growth curve analysis. The total department mean EQ-i score in pretraining year 2005 was 104.29 ("average" range), with posttraining scores in the "high average" range (112.46 in 2006, 111.67 in 2007, and 113.15 in 2008). An increase in EQ-i scores and EI training corresponded with an increase in patient satisfaction scores. Percentile rank patient satisfaction scores before EI training ranged from 85% to 90%; after training, scores ranged from 92% to 99%. Conclusions and relevance: Emotional intelligence training positively influences patient satisfaction and may enhance medical education and health care outcome.

JAMA otolaryngology-- head & neck surgery · 60 citationsread the source →

Supportive care needs of women with gynecologic cancer.

Gynecologic cancers often place a heavy emotional and physical burden on patients. However, there is a lack of information about the types of supportive care needs that these patients have, the services that are available, and whether patients want help with their needs. The aims of this cross-sectional, descriptive study were to (1) identify the supportive care needs (physical, emotional, social, spiritual, psychological, informational, and practical) of women with gynecologic cancer who attended a comprehensive, outpatient cancer center in Ontario, Canada, and (2) determine if patients wanted assistance in meeting those needs. A total of 103 patients participated in this study by completing a self-report questionnaire. Sixty-five of the women were no longer on treatment at the time of completing the survey. Eight of the top 10 most frequently reported needs were non physical, such as fears about the cancer returning or spreading. The data indicated that a range of needs remained unmet for this patient group. However, identifying the presence of a need did not necessarily mean that a patient wanted to have assistance with the need. Suggestions for practice and future research are offered to assist healthcare professionals in providing care to these patients.

Cancer nursing · 83 citationsread the source →

Risk of depression and other mental health disorders in women with polycystic ovary syndrome: a longitudinal study.

Objective: To determine the conversion risk and predictors for depression in women with polycystic ovary syndrome. Design: Prospective longitudinal study. Setting: University practice. Patient(s): Subjects with polycystic ovary syndrome who had participated in a previous study. Intervention(s): None. Main outcome measure(s): The Primary Care Evaluation of Mental Disorders Patient Health Questionnaire was used to diagnose major depressive disorder and other depressive syndromes, anxiety syndromes, and binge eating disorder. Subjects completed a questionnaire on knowledge about polycystic ovary syndrome and treatment satisfaction. Result(s): A total of 60 of 103 subjects responded to the second survey. Mean time between the two surveys was 22 months (range 12-26 months). The overall prevalence of depression was 40% (24/60). Of these, 10 women screened positive for major depressive disorder or other depressive syndromes and 14 were receiving antidepressant medications. There were 11 new cases identified in the second survey (19% conversion). Total subjects with mood disorders in this study were 34/60 (56.6%), including 11.6% with anxiety syndromes and 23.3% with binge eating disorder. Difficulties with menstrual function, fertility, and body image (weight, hirsutism, acne) were not significantly different in women with and without depression. Conclusion(s): There is a significant risk for mood disorders (defined by the Diagnostic and Statistical Manual of Mental Disorders-IV) in women with polycystic ovary syndrome. This finding together with a high conversion risk for depression over a 1- to 2-year period underscores the importance of routine screening and aggressive treatment of mental health disorders in this population.

Fertility and sterility · 132 citationsread the source →

Effective interactions: Communication and high levels of marital satisfaction

Of all the significant relationships in the lives of human-beings, the marital relationship remains one of the most central and important to their well-being. For this rapid review the authors accessed four online databases (PsycINFO, PsychARTICLES, JSTOR Journals, and ScienceDirect) to examine the evidence on aspects of communication which contribute to high levels of marital satisfaction and to synthesise these findings. The search yielded 103 unique articles, of which 15 were ultimately included. Principal results found the following activities to relate to high marital satisfaction: 1) communication activities such as engaging in small talk and providing verbal and non-verbal messages of affection; 2) “positive” exchanges which include any interactions perceived by both parties as constructive; 3) effective conflict management including the use of responses of recalibration and reaffirmation (R-R response), the use of we-pronouns, and the Listener-Speaker technique; 4) possessing and implementing effective communication skills such as using “I” instead of “you” messages; and 5) using “positive” communication skills such as clarification to elicit “positive” affect such as feeling understood. The evidence suggests that mental health professionals working with married couples should seek to promote quality dyadic communication as part of treatment interventions.

Journal of Psychology in Africa · 39 citationsread the source →