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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 →

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 →

Implementation and evaluation of a harm-reduction model for clinical care of substance using pregnant women.

Background: Methamphetamine (MA) use during pregnancy is associated with many pregnancy complications, including preterm birth, small for gestational age, preeclampsia, and abruption. Hawaii has lead the nation in MA use for many years, yet prior to 2007, did not have a comprehensive plan to care for pregnant substance-using women. In 2006, the Hawaii State Legislature funded a pilot perinatal addiction clinic. The Perinatal Addiction Treatment Clinic of Hawaii was built on a harm-reduction model, encompassing perinatal care, transportation, child-care, social services, family planning, motivational incentives, and addiction medicine. We present the implementation model and results from our first one hundred three infants (103) seen over 3 years of operation of the program. Methods: Referrals came from community health centers, hospitals, addiction treatment facilities, private physician offices, homeless outreach services and self-referral through word-of-mouth and bus ads. Data to describe sample characteristics and outcome was obtained prospectively and retrospectively from chart abstraction and delivery data. Drug use data was obtained from the women's self-report and random urine toxicology during the pregnancy, as well as urine toxicology at the time of birth on mothers, and urine and meconium toxicology on the infants. Post-partum depression was measured in mothers with the Edinburgh Post-Partum depression scale. Data from Path clinic patients were compared with a representative cohort of women delivering at Kapiolani Medical Center for Women and Children during the same time frame, who were enrolled in another study of pregnancy outcomes. Ethical approval for this study was obtained through the University of Hawaii Committee for Human Studies. Results: Between April 2007 and August 2010, 213 women with a past or present history of addiction were seen, 132 were pregnant and 97 delivered during that time. 103 live-born infants were delivered. There were 3 first-trimester Spontaneous Abortions, two 28-week intrauterine fetal deaths, and two sets of twins and 4 repeat pregnancies. Over 50% of the women had lost custody of previous children due to substance use. The majority of women who delivered used methamphetamine (86%), either in the year before pregnancy or during pregnancy. Other drugs include marijuana (59.8%), cocaine (33%), opiates (9.6%), and alcohol (15.2%). Of the women served, 85% smoked cigarettes upon enrollment. Of the 97 women delivered during this period, all but 4 (96%) had negative urine toxicology at the time of delivery. Of the 103 infants, 13 (12.6%) were born preterm, equal to the state and national average, despite having many risk factors for prematurity, including poverty, poor diet, smoking and polysubstance use. Overwhelmingly, the women are parenting their children, > 90% retained custody at 8 weeks. Long-term follow-up showed that women who maintained custody chose long-acting contraceptive methods; while those who lost custody had a very high (> 50%) repeat pregnancy rate at 9 months post delivery. Conclusion: Methamphetamine use during pregnancy doesn't exist is isolation. It is often combined with a multitude of other adverse circumstances, including poverty, interpersonal violence, psychiatric comorbidity, polysubstance use, nutritional deficiencies, inadequate health care and stressful life experiences. A comprehensive harm reduction model of perinatal care, which aims to ameliorate some of these difficulties for substance-using women without mandating abstinence, provides exceptional birth outcomes and can be implemented with limited resources.

Harm reduction journal · 42 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 →

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 →

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 →

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 →

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 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 →

Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents.

Background: Adolescent depression and anxiety symptoms are prevalent in sub-Saharan African countries, yet treatment options are scarce, and stigma limits help-seeking. Brief, computerized single-session interventions (SSIs) that contain empirically supported stigma-reducing elements may help expand access to treatment. We developed and evaluated such an intervention for Kenyan adolescents. Method: High school students (N = 103, age 13-18) were randomized to a digital SSI Shamiri-Digital (Shamiri means "thrive" in Kiswahili) or a study-skills control intervention. Shamiri-Digital consisted of reading and writing activities about 3 concepts: growth mindset, gratitude, and value affirmation. Both Shamiri-Digital and the study-skills control condition were delivered electronically in schools. Results: Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up. The effects exceed the mean effects reported in meta-analyses of full-length, face-to-face psychotherapy for youth depression. There were no significant effects on anxiety symptoms, well-being, or happiness. Conclusion: This is the first report that a brief, computerized SSI may reduce depressive symptoms in adolescents in sub-Saharan Africa. Replication trials with extended follow-ups will help gauge the strength and durability of these effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Journal of consulting and clinical psychology · randomised controlled trial · 87 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 →

Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.

Importance: Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation. Objective: To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity. Design: Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016. Setting: Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city. Participants: 103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years). Interventions: Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development. Main outcomes and measures: Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days. Results: ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038. Conclusions and relevance: ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes. Trial registration: clinicaltrials.gov Identifier: NCT02093052.

Psychoneuroendocrinology · randomised controlled trial · 29 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 →

Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial.

Purpose: The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and methods: Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results: Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion: Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 244 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 →

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 →

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 →

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 →

Investigating the Feasibility of Brief Compassion Focused Therapy in Individuals in Treatment for Opioid Use Disorder.

Opioid use disorder (OUD) is reaching epidemic proportions worldwide, and is notoriously difficult to treat. Compassion focused therapy (CFT) has emerged as therapeutic tool for treating individuals exhibiting high levels of self-criticism and low self-esteem, both of which are common in OUD. Until now, however, there had been no research investigating this therapy in patients with OUD. Before running a premature clinical trial, it is important to fully assess the feasibility and acceptability of this treatment in this group of individuals. We aimed to assess the feasibility of CFT treatment in individuals with OUD in a short group intervention, which was co-created by the research team, service users and a local drugs service. The intervention involved three 2-hour sessions held over 3 weeks, where participants engaged in compassion-orientated psychoeducation and self-compassionate exercises. Individuals were randomly assigned to either the CFT group (n = 15), the active control (relaxation) group (n = 12) or the waitlist control group (n = 11). Of 103 individuals approached, 45% attended a baseline visit suggesting the treatment was acceptable to this group. A relatively low attrition rate across the 3 groups was found for CFT (21.1%), with no difference in drop-out between the groups. Qualitative analysis of interviews with participants identified a desire for more sessions. Compassion focused therapy was thus feasible and well-tolerated in those with OUD, and a further trial to evaluate any clinical differences may be warranted.

Substance abuse : research and treatment · 7 citationsread the source →

Predicting Need for Follow-Up Due to Severe Anxiety and Depression Symptoms After Perinatal Loss.

Objective: To evaluate the ability of the Perinatal Grief Intensity Scale (PGIS) when used within 8 weeks of perinatal loss to predict intense anxiety and severe depression symptoms in women 3 months later (Time 2 [T2]). Design: Prospective survey. Setting: Participants were recruited from hospitals in Louisville, KY and via the Internet. Participants: Women (N = 103) who experienced perinatal loss. Methods: Data were collected using the PGIS, Beck Anxiety Inventory, and the Center for Epidemiologic Studies Depression Scale. We used logistic regression, odds ratios, and receiver operating characteristic curve analysis. Results: The PGIS had 97.9% sensitivity and 29.6% specificity to predict severe depression symptoms and 95.2% sensitivity and 56.2% specificity to predict intense anxiety at T2. A baseline PGIS score greater than or equal to 3.53 predicted severe depression symptoms (odds ratio = 1.82, 95% confidence interval [CI] [1.46, 2.18], p = .014) and intense anxiety (odds ratio = 1.43, 95% CI [1.07, 1.82], p = .029) at T2. The receiver operating characteristic curves of the PGIS suggest the PGIS performs well at predicting (screening positive) for severe depression symptoms (area under the curve = 0.86, 95% CI [0.79, 0.94], p < .001) and intense anxiety (area under the curve = 0.86, 95% CI [0.78, 0.93], p < .001) after perinatal loss. Conclusion: The PGIS accurately predicted intense anxiety and severe depression symptoms 3 to 5 months after perinatal loss. This instrument may help health care providers identify women who need further mental health evaluation after perinatal loss.

Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · 16 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 →

Mortality salience leads to greater consumption of an ostensibly alcoholic beverage on Friday versus other weekdays.

Objectives: We build on findings from terror management theory to examine how non-conscious mortality concerns may lead individuals to adhere to cultural meanings yoked to discrete time periods, in this case influencing consumption of an ostensibly alcoholic beverage. Design: The study took the form of a 2 (death vs. uncertainty reminder) × 3 (Monday vs. Wednesday vs. Friday) between-subjects laboratory-based quasi-experimental design. Methods: A total of 210 participants (age: M = 21.92 years, SD = 5.33; 103 males and 107 females) recruited from a UK university answered either an open-ended question to prime mortality or uncertainty cognition on either a Monday, Wednesday, or Friday. As part of an ostensible taste test, they then consumed as much or as little of a purportedly alcoholic drink as they desired. Results: Death reminders (vs. control topic) were found to result in more consumption of the beverage on a Friday, less consumption on a Monday, and no difference in consumption on a Wednesday. Conclusions: Findings point to the flexible, time-contingent nature of culture-oriented defences against mortality concerns with potential implications for the efficacy of alcohol health warnings featuring mortality-related stimuli. Statement of contribution What is already known on this subject? Death reminders can spur people to adhere to cultural scripts for behaviour in the service of maintaining existential security. Death reminders can lead people to consume alcohol (particularly for those who are low in self-esteem). What does this study add? Death reminders may lead people to adhere to temporally yoked scripts related to drinking behaviour. Specifically, death reminders led to more positive drinking attitudes and more alcohol consumed on Friday compared to Monday or Wednesday. Cultural script following may be specifically tied to non-conscious mortality awareness.

British journal of health psychology · 3 citationsread the source →

Early Intervention with a Parent-Delivered Massage Protocol Directed at Tactile Abnormalities Decreases Severity of Autism and Improves Child-to-Parent Interactions: A Replication Study.

Tactile abnormalities are severe and universal in preschool children with autism. They respond well to treatment with a daily massage protocol directed at tactile abnormalities (QST massage for autism). Treatment is based on a model for autism proposing that tactile impairment poses a barrier to development. Two previous randomized controlled trials evaluating five months of massage treatment reported improvement of behavior, social/communication skills, and tactile and other sensory symptoms. This is the first report from a two-year replication study evaluating the protocol in 103 preschool children with autism. Parents gave daily treatment; trained staff gave weekly treatment and parent support. Five-month outcomes replicated earlier studies and showed normalization of receptive language (18%, P = .03), autistic behavior (32%, P = .006), total sensory abnormalities (38%, P = .0000005), tactile abnormalities (49%, P = .0002), and decreased autism severity (medium to large effect size, P = .008). In addition, parents reported improved child-to-parent interactions, bonding, and decreased parenting stress (44%, P = .00008). Early childhood special education programs are tasked with addressing sensory abnormalities and engaging parents in effective home programs. Until now, they have lacked research-based methods to do so. This program fulfills the need. It is recommended to parents and ECSE programs (ages 3-5) at autism diagnosis.

Autism research and treatment · 21 citationsread the source →

Individual differences in delay discounting: relation to intelligence, working memory, and anterior prefrontal cortex.

Lower delay discounting (better self-control) is linked to higher intelligence, but the basis of this relation is uncertain. To investigate the potential role of working memory (WM) processes, we assessed delay discounting, intelligence (g), WM (span tasks, 3-back task), and WM-related neural activity (using functional magnetic resonance imaging) in 103 healthy adults. Delay discounting was negatively correlated with g and WM. WM explained no variance in delay discounting beyond that explained by g, which suggests that processes through which WM relates to delay discounting are shared by g. WM-related neural activity in left anterior prefrontal cortex (Brodmann's area 10) covaried with g, r= .26, and delay discounting, r=-.40, and partially mediated the relation between g and delay discounting. Overall, the results suggest that delay discounting is associated with intelligence in part because of processes instantiated in anterior prefrontal cortex, a region known to support the integration of diverse information.

Psychological science · 267 citationsread the source →

Twelve-year course and outcome predictors of anorexia nervosa.

Objective: The current study presents the long-term course of anorexia nervosa (AN) over 12 years in a large sample of 103 patients diagnosed according to criteria in the 4th ed. of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Method: Assessments were made at the beginning of therapy, at the end of therapy, at the 2-year follow-up, at the 6-year follow-up, and at the 12-year follow-up. Self-rating and an expert-rating interview data were obtained. Results: The participation rate at the 12-year follow-up was 88% of those alive. There was substantial improvement during therapy, a moderate (in many instances nonsignificant) decline during the first 2 years posttreatment, and further improvement from 3 to 12 years posttreatment. Based on a global 12-year outcome score, 27.5% had a good outcome, 25.3% an intermediate outcome, 39.6% had a poor outcome, and 7 (7.7%) were deceased. At the 12-year follow-up 19.0% had AN, 9.5% had bulimia nervosa-purging type (BN-P), 19.0% were classified as eating disorder not otherwise specified (EDNOS). A total of 52.4% showed no major DSM-IV eating disorder and 0% had binge eating disorder (BED). Systematic-strictly empirically based-model building resulted in a parsimonious model including four predictors of unfavorable 12-year outcome explaining 45% of the variance, that is, sexual problems, impulsivity, long duration of inpatient treatment, and long duration of an eating disorder. Conclusion: Mortality was high and symptomatic recovery protracted. Impulsivity, symptom severity, and chronicity were the important factors for predicting the 12-year outcome.

The International journal of eating disorders · 225 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 →