Study protocol for a controlled trial of a resilience program on psychological distress in correctional officers in Australia.

BACKGROUND: The mental health impacts of workers within correctional settings has been of increasing focus over the past number of years. This paper outlines the study protocol for a trial that tests the efficacy of a brief resilience program, relative to a no intervention control in reducing general psychological distress and absenteeism in a cohort of correctional personnel in NSW, Australia. METHODS: A, parallel, randomized controlled trial will be carried out in a small group format. Following informed consent, corrective personnel within prisons across NSW will volunteer to either attend a clinician delivered resilience program on stress management skills or not (N = 600). The primary outcome will be change in psychological distress including anxiety and depression at 2-months post intervention. Secondary outcomes include help-seeking behaviours and absenteeism. DISCUSSION: This prevention focused treatment trial will assess whether a brief clinician delivered resilience program will reduce absenteeism and mitigate psychological distress in a cohort of corrective personnel within NSW, Australia. This study will yield insights into the role of a brief psychological program in mitigating the psychological distress reported by personnel in correctional settings. TRIAL REGISTRATION: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622000029796). ETHICS AND DISSEMINATION: Ethics approval has been obtained from University of New South Wales Human Research Ethics Committee. Results of the trial will be submitted for publication in peer reviewed journals and findings presented at scientific conferences and to key service providers and policy makers.

Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial.

BACKGROUND: Millions of young adolescents in low- and middle-income countries (LMICs) affected by humanitarian crises experience elevated rates of poor mental health. There is a need for scalable programs that can improve the mental health of young adolescents. This study evaluated the effectiveness of a nonspecialist delivered group-based intervention (Early Adolescent Skills for Emotions (EASE)) to improve young adolescents' mental health. METHODS AND FINDINGS: In this single-blind, parallel, controlled trial, Syrian refugees aged 10 to 14 years in Jordan were identified through screening of psychological distress as defined by scores ≥15 on the Paediatric Symptom Scale. Participants were randomised to either EASE or enhanced usual care (EUC) involving referral to local psychosocial services (on a 1:1.6 ratio). Participants were aware of treatment allocation but assessors were blinded. Primary outcomes were scores on the Paediatric Symptom Checklist (PSC; internalising, externalising, and attentional difficulty scales) assessed at week 0, 9 weeks, and 3 months after treatment (primary outcome time point). It was hypothesised that EASE would result in greater reductions on internalising symptoms than EUC. Secondary outcomes were depression, posttraumatic stress, well-being, functioning, school belongingness, and caregivers' parenting and mental health. Between June 2019 and January 2020, 1,842 young adolescent refugees were screened for eligibility on the basis of psychological distress. There were 520 adolescents (28.2%) who screened positive, of whom 471 (90.6%) agreed to enter the trial. Overall, 185 were assigned to EASE and 286 to EUC, and 169 and 254 were retained at 3 months for EASE and EUC, respectively. Intent-to-treat analyses indicated that at 3 months, EASE resulted in greater reduction on the PSC-internalising scale than EUC (estimated mean difference 0.69, 95% CI 0.19 to 1.19; p = 0.007; effect size, 0.38) but there were no differences for PSC-externalising (estimated mean difference 0.24, 95% CI -0.43 to 0.91; p = 0.49; effect size, -0.10), PSC-attentional problem (estimated mean difference -0.01, 95% CI -0.51 to 0.54; p = 0.97; effect size, -0.01) scores, or on depression, posttraumatic stress, well-being, functioning, or school belongingness. Relative to EUC, caregivers in EASE had less psychological distress (estimated mean difference 1.95, 95% CI 0.71 to 3.19; p = 0.002) and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < 0.001). Secondary analyses that (a) focused on adolescents with probable internalising disorders; (b) completed the 3-month assessment; and (c) controlled for trauma exposure did not alter the primary results. Mediation analysis indicated that for caregivers in the EASE condition, reduction in inconsistent disciplinary parenting was associated with reduced attentional (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) and internalising (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) problems in their children. No adverse events were attributable to the intervention. A limitation was that EUC was not matched to EASE in terms of facilitator attention or group involvement. CONCLUSIONS: EASE led to reduced internalising problems in young refugee adolescents and was associated with reduced distress and less inconsistent disciplinary parenting in caregivers. This intervention has the potential as a scalable intervention to mitigate young adolescents' emotional difficulties in LMIC. TRIAL REGISTRATION: Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619000341123.

Effectiveness of a Videoconferencing-Delivered Psychological Intervention for Mental Health Problems during COVID-19: A Proof-of-Concept Randomized Clinical Trial.

INTRODUCTION: Anxiety and depression have increased markedly during the COVID-19 pandemic. There is a lack of evidence-based strategies to address these mental health needs during the pandemic. OBJECTIVE: We aim to conduct a proof-of-concept trial of the efficacy of a brief group-based psychological intervention delivered via videoconferencing for adults in Australia distressed by the pandemic. METHODS: In this single-blind, parallel, randomised controlled trial, adults who screened positive for COVID-related psychological distress across Australia were randomly allocated to either a 6-session group-based program based on behavioural principles (n = 120) or enhanced usual care (EUC, n = 120). Primary outcome was total score on the Hospital Anxiety and Depression (HADS) anxiety and depression subscales assessed at baseline, 1 week posttreatment, 2 months (primary outcome time point), and 6 months after treatment, as well as secondary outcome measures of worry, sleep impairment, anhedonia, mood, and COVID-19-related stress. RESULTS: Between May 20, 2020, and October 20, 2020, 240 patients were enrolled into the trial. Relative to EUC, at 2 months participants receiving intervention showed greater reduction on anxiety (mean difference, 1.4 [95% CI, 0.3 to 2.6], p = 0.01; effect size, 0.4 [95% CI, 0.1 to 0.7]) and depression (mean difference, 1.6 [95% CI, 0.4 to 2.8], p = 0.009; effect size, 0.4 [95% CI, 0.2 to 0.7]) scales. These effects were maintained at 6 months. There were also greater reductions of worry, anhedonia, COVID-19-related fears, and contamination fears. CONCLUSIONS: This trial provides initial evidence that brief group-based behavioural intervention delivered via videoconferencing results in moderate reductions in common psychological problems arising during the COVID-19 pandemic. This program may offer a viable and scalable means to mitigate the rising mental health problems during the pandemic.

Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial.

BACKGROUND: Globally, 235 million people are impacted by humanitarian emergencies worldwide, presenting increased risk of experiencing a mental disorder. Our objective was to test the effectiveness of a brief group psychological treatment delivered by trained facilitators without prior professional mental health training in a disaster-prone setting. METHODS AND FINDINGS: We conducted a cluster randomized controlled trial (cRCT) from November 25, 2018 through September 30, 2019. Participants in both arms were assessed at baseline, midline (7 weeks post-baseline, which was approximately 1 week after treatment in the experimental arm), and endline (20 weeks post-baseline, which was approximately 3 months posttreatment). The intervention was Group Problem Management Plus (PM+), a psychological treatment of 5 weekly sessions, which was compared with enhanced usual care (EUC) consisting of a family psychoeducation meeting with a referral option to primary care providers trained in mental healthcare. The setting was 72 wards (geographic unit of clustering) in eastern Nepal, with 1 PM+ group per ward in the treatment arm. Wards were eligible if they were in disaster-prone regions and residents spoke Nepali. Wards were assigned to study arms based on covariate constrained randomization. Eligible participants were adult women and men 18 years of age and older who met screening criteria for psychological distress and functional impairment. Outcomes were measured at the participant level, with assessors blinded to group assignment. The primary outcome was psychological distress assessed with the General Health Questionnaire (GHQ-12). Secondary outcomes included depression symptoms, posttraumatic stress disorder (PTSD) symptoms, "heart-mind" problems, social support, somatic symptoms, and functional impairment. The hypothesized mediator was skill use aligned with the treatment's mechanisms of action. A total of 324 participants were enrolled in the control arm (36 wards) and 319 in the Group PM+ arm (36 wards). The overall sample (N = 611) had a median age of 45 years (range 18-91 years), 82% of participants were female, 50% had recently experienced a natural disaster, and 31% had a chronic physical illness. Endline assessments were completed by 302 participants in the control arm (36 wards) and 303 participants in the Group PM+ arm (36 wards). At the midline assessment (immediately after Group PM+ in the experimental arm), mean GHQ-12 total score was 2.7 units lower in Group PM+ compared to control (95% CI: 1.7, 3.7, p < 0.001), with standardized mean difference (SMD) of -0.4 (95% CI: -0.5, -0.2). At 3 months posttreatment (primary endpoint), mean GHQ-12 total score was 1.4 units lower in Group PM+ compared to control (95% CI: 0.3, 2.5, p = 0.014), with SMD of -0.2 (95% CI: -0.4, 0.0). Among the secondary outcomes, Group PM+ was associated with endline with a larger proportion attaining more than 50% reduction in depression symptoms (29.9% of Group PM+ arm versus 17.3% of control arm, risk ratio = 1.7, 95% CI: 1.2, 2.4, p = 0.002). Fewer participants in the Group PM+ arm continued to have "heart-mind" problems at endline (58.8%) compared to the control arm (69.4%), risk ratio = 0.8 (95% CI, 0.7, 1.0, p = 0.042). Group PM+ was not associated with lower PTSD symptoms or functional impairment. Use of psychosocial skills at midline was estimated to explain 31% of the PM+ effect on endline GHQ-12 scores. Adverse events in the control arm included 1 suicide death and 1 reportable incidence of domestic violence; in the Group PM+ arm, there was 1 death due to physical illness. Study limitations include lack of power to evaluate gender-specific effects, lack of long-term outcomes (e.g., 12 months posttreatment), and lack of cost-effectiveness information. CONCLUSIONS: In this study, we found that a 5-session group psychological treatment delivered by nonspecialists modestly reduced psychological distress and depression symptoms in a setting prone to humanitarian emergencies. Benefits were partly explained by the degree of psychosocial skill use in daily life. To improve the treatment benefit, future implementation should focus on approaches to enhance skill use by PM+ participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03747055.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial.

BACKGROUND: Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.

BACKGROUND: Gender-based violence (GBV) represents a major cause of psychological morbidity worldwide, and particularly in low- and middle-income countries (LMICs). Although there are effective treatments for common mental disorders associated with GBV, they typically require lengthy treatment programs that may limit scaling up in LMICs. The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus (PM+) that lay community workers can be taught to deliver. METHODS AND FINDINGS: In this single-blind, parallel, randomised controlled trial, adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi, Kenya. Participants were randomly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care (EUC) provided by community nurses. Participants were aware of treatment allocation, but research assessors were blinded. The primary outcome was psychological distress as measured by the total score on the 12-item General Health Questionnaire (GHQ-12) assessed at 3 months after treatment. Secondary outcomes were impaired functioning (measured by the WHO Disability Adjustment Schedule [WHODAS]), symptoms of posttraumatic stress (measured by the Posttraumatic Stress Disorder Checklist [PCL]), personally identified problems (measured by Psychological Outcome Profiles [PSYCHLOPS]), stressful life events (measured by the Life Events Checklist [LEC]), and health service utilisation. Between 15 April 2015 and 20 August 2015, 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning. Of these, 518 women (37%) screened positive, of whom 421 (81%) were women who had experienced GBV. Of these 421 women, 209 were assigned to PM+ and 212 to EUC. Follow-up assessments were completed on 16 January 2016. The primary analysis was intention to treat and included 53 women in PM+ (25%) and 49 women in EUC (23%) lost to follow-up. The difference between PM+ and EUC in the change from baseline to 3 months on the GHQ-12 was 3.33 (95% CI 1.86-4.79, P = 0.001) in favour of PM+. In terms of secondary outcomes, for WHODAS the difference between PM+ and EUC in the change from baseline to 3-month follow-up was 1.96 (95% CI 0.21-3.71, P = 0.03), for PCL it was 3.95 (95% CI 0.06-7.83, P = 0.05), and for PSYCHLOPS it was 2.15 (95% CI 0.98-3.32, P = 0.001), all in favour of PM+. These estimated differences correspond to moderate effect sizes in favour of PM+ for GHQ-12 score (0.57, 95% CI 0.32-0.83) and PSYCHLOPS (0.67, 95% CI 0.31-1.03), and small effect sizes for WHODAS (0.26, 95% CI 0.02-0.50) and PCL (0.21, 95% CI 0.00-0.41). Twelve adverse events were reported, all of which were suicidal risks detected during screening. No adverse events were attributable to the interventions or the trial. Limitations of the study include no long-term follow-up, reliance on self-report rather than structured interview data, and lack of an attention control condition. CONCLUSIONS: Among a community sample of women in urban Kenya with a history of GBV, a brief, lay-administered behavioural intervention, compared with EUC, resulted in moderate reductions in psychological distress at 3-month follow-up. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001291673.

Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi.

BACKGROUND: Living in conditions of chronic adversity renders many women more vulnerable to experiencing gender-based violence (GBV). In addition to GBV's physical and social consequences, the psychological effects can be pervasive. Access to evidence-based psychological interventions that seek to support the mental health of women affected by such adversity is rare in low- and middle-income countries. METHODS: The current study evaluates a brief evidence-informed psychological intervention developed by the World Health Organization for adults impacted by adversity (Problem Management Plus; PM+). A feasibility randomised control trial (RCT) was conducted to inform a fully powered trial. Community health workers delivered the intervention to 70 women residing in three peri-urban settings in Nairobi, Kenya. Women, among whom 80% were survivors of GBV (N = 56), were randomised to receive five sessions of either PM+ (n = 35) by community health workers or enhanced treatment as usual (ETAU; n = 35). RESULTS: PM+ was not associated with any adverse events. Although the study was not powered to identify effects and accordingly did not identify effects on the primary outcome measure of general psychological distress, women survivors of adversity, including GBV, who received PM+ displayed greater reductions in posttraumatic stress disorder symptoms following treatment than those receiving ETAU. CONCLUSIONS: This feasibility study suggests that PM+ delivered by lay health workers is an acceptable and safe intervention to reach women experiencing common mental disorders and be inclusive for those affected by GBV and can be studied in a RCT in this setting. The study sets the stage for a fully powered, definitive controlled trial to assess this potentially effective intervention. TRIAL REGISTRATION: ACTRN12614001291673 , 10/12/2014, retrospectively registered during the recruitment phase.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

Importance: The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions: Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures: Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results: Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance: Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.

Cognitive Behavior Therapy vs Mindfulness in Treatment of Prolonged Grief Disorder: A Randomized Clinical Trial.

Importance: Although grief-focused cognitive behavior therapies are the most empirically supported treatment for prolonged grief disorder, many people find this treatment difficult. A viable alternative for treatment is mindfulness-based cognitive therapy. Objective: To examine the relative efficacies of grief-focused cognitive behavior therapy and mindfulness-based cognitive therapy to reduce prolonged grief disorder severity. Design, Setting, and Participants: A single-blind, parallel, randomized clinical trial was conducted among adults aged 18 to 70 years with prolonged grief disorder, as defined in the International Classification of Diseases, 11th Revision, and assessed by clinical interview based on the Prolonged Grief-13 (PG-13) scale. Those with severe suicidal risk, presence of psychosis, or substance dependence were excluded. Between November 2012 and November 2022, eligible participants were randomized 1:1 to eleven 90-minute sessions of grief-focused cognitive behavior therapy or mindfulness-based cognitive therapy at a traumatic stress clinic in Sydney, Australia, with follow-up through 6 months. Interventions: Both groups received once-weekly 90-minute individual sessions for 11 weeks. Grief-focused cognitive behavior therapy comprised 5 sessions of recalling memories of the deceased, plus cognitive restructuring and planning future social and positive activities. Mindfulness-based cognitive therapy comprised mindfulness exercises adapted to tolerate grief-related distress. Main Outcomes and Measures: The primary outcome was change in prolonged grief disorder severity measured by the PG-13 scale assessed at baseline, 1 week posttreatment, and 6 months after treatment (primary outcome time point), as well as secondary outcome measures of depression, anxiety, grief-related cognition, and quality of life. Results: The trial included 100 participants (mean [SD] age, 47.3 [13.4] years; 87 [87.0%] female), 50 in the grief-focused cognitive behavior therapy condition and 50 in the mindfulness-based cognitive therapy condition. Linear mixed models indicated that at the 6-month assessment, participants in the grief-focused cognitive behavior therapy group showed greater reduction in PG-13 scale score relative to those in the mindfulness-based cognitive therapy group (mean difference, 7.1; 95% CI, 1.6-12.5; P = .01), with a large between-group effect size (0.8; 95% CI, 0.2-1.3). Participants in the grief-focused cognitive behavior therapy group also demonstrated greater reductions in depression as measured on the Beck Depression Inventory than those in the mindfulness-based cognitive therapy group (mean difference, 6.6; 95% CI, 0.5-12.9; P = .04) and grief-related cognition (mean difference, 14.4; 95% CI, 2.8-25.9; P = .02). There were no other significant differences between treatment groups and no reported adverse events. Conclusions and Relevance: In this study, grief-focused cognitive behavior therapy conferred more benefit for core prolonged grief disorder symptoms and associated problems 6 months after treatment than mindfulness-based cognitive therapy. Although both treatments may be considered for prolonged grief disorder, grief-focused cognitive behavior therapy might be the more effective choice, taking all factors into consideration. Trial Registration: anzctr.org.au Identifier: ACTRN12612000307808.

A pilot study of the role of the BDNF Val66Met polymorphism in response to exercise-augmented exposure therapy for posttraumatic stress disorder.

Brain-Derived Neurotrophic Factor (BDNF) is implicated in extinction learning, which is a primary mechanism of exposure therapy for posttraumatic stress disorder (PTSD). Brief aerobic exercise has been shown to promote BDNF release and augment extinction learning. On the premise that the Val allele of the BDNF Val66Met polymorphism facilitates greater release of BDNF, this study examined the extent to which the Val allele of the BDNF polymorphism predicted treatment response in PTSD patients who underwent exposure therapy combined with aerobic exercise or passive stretching. PTSD patients (N = 85) provided saliva samples in order to extract genomic DNA to identify Val/Val and Met carriers of the BDNF Val66Met genotype, and were assessed for PTSD severity prior to and following a 9-week course of exposure therapy combined with aerobic exercise or stretching. The sample comprised 52 Val/Val carriers and 33 Met carriers. Patients with the BDNF high-expression Val allele display greater reduction of PTSD symptoms at posttreatment than Met carriers. Hierarchical regression analysis indicated that greater PTSD reduction was specifically observed in Val/Val carriers who received exposure therapy in combination with the aerobic exercise. This finding accords with animal and human evidence that the BDNF Val allele promotes greater extinction learning, and that these individuals may benefit more from exercise-augmented extinction. Although preliminary, this result represents a possible avenue for augmented exposure therapy in patients with the BDNF Val allele.

Efficacy of a brief psychological intervention to reduce distress in healthcare workers during the COVID-19 pandemic: A randomized controlled trial.

INTRODUCTION: The COVID-19 pandemic has led to a sharp increase in mental health problems among healthcare workers (HCWs). Accessible interventions for HCWs are needed to reduce distress during the pandemic. OBJECTIVE: This study evaluated the efficacy of a brief psychological intervention (RECHARGE) delivered by videoconferencing to reduce psychological distress in HCWs. METHOD: This single-blind, parallel, randomized controlled trial enrolled HCWs in Switzerland who screened positive for psychological distress. Participants were randomly allocated to RECHARGE, that taught behavioral strategies or active treatment as usual (ATAU). Primary outcome was the total score on the Kessler Psychological Distress Scale (K10) measured at baseline, post-intervention, 2-month (primary outcome time point), and 6-month follow-up. Secondary outcomes included worry, anxiety and depression, burnout, traumatic stress, moral injury distress, and work performance. RESULTS: Between August 2020 and May 2021, 160 HCWs were enrolled in the study (RECHARGE = 82, ATAU = 78). Relative to ATAU, at 2 months RECHARGE led to a greater reduction in psychological distress (mean difference = 1.86, 95% confidence interval [CI .28, .34], p = .02; effect size = .37), and greater reductions in worry, burnout, and moral injury distress. These effects were not maintained at 6 months. CONCLUSIONS: This trial provides initial evidence that a brief psychological intervention delivered via videoconferencing results in significant reductions in mental health problems arising during the COVID-19 pandemic. Booster sessions or digital tools may be needed to maintain the initial gains achieved by RECHARGE. This intervention may have utility in improving the mental health of HCWs both during pandemics and everyday stressors. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial.

BACKGROUND: Although exposure therapy is central in most front-line psychotherapies of post-traumatic stress disorder (PTSD), many patients do not respond to this treatment. We aimed to investigate the effects of brief aerobic exercise on the efficacy of exposure therapy in reducing the severity of PTSD. METHODS: We did a single-blind, parallel, randomised controlled trial in Sydney, NSW, Australia. We included adults (aged ≥18 years) with clinician-diagnosed PTSD. We excluded participants aged 70 years or older, with imminent suicidal risk (reporting suicidal plan), presence of psychosis or substance dependence, history of moderate-to-severe traumatic brain injury, or presence of a physical disorder or impairment that might be exacerbated by aerobic exercise (eg, back pain). We randomly assigned participants (1:1) to nine 90-min weekly sessions of exposure therapy for PTSD with 10 min aerobic exercise or to the control group of exposure therapy with 10 min passive stretching. The primary outcome was PTSD severity measured by the clinician-administered PTSD scale 2 (CAPS-2), independently assessed at baseline, 1 week after treatment, and 6 months after treatment (primary outcome timepoint). FINDINGS: Between Dec 12, 2012, and July 25, 2018, we enrolled 130 participants with PTSD, with 65 (50%) participants randomly assigned to exposure therapy with exercise and 65 (50%) to exposure therapy with passive stretching, including 79 (61%) women and 51 (39%) men, with a mean age of 39·1 years (SD 14·4; range 18-69). 99 (76%) participants were White, 14 (11%) were Asian, and 17 (13%) were listed as other. At the 6-month follow-up assessment, participants in the exposure therapy with exercise group showed greater reductions in CAPS-2 scores relative to those in the exposure therapy with stretching group (mean difference 12·1 [95% CI 2·4-21·8]; p=0·023), which resulted in a moderate effect size of 0·6 (0·1-1·1). No adverse events associated with the intervention were reported. The trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12612000185864. INTERPRETATION: Brief aerobic exercise has the potential to augment long-term gains of exposure therapy for PTSD, which accords with evidence from studies in animals and humans on the role of exercise in modulating the extinction learning processes. This strategy might offer a simple and affordable means to augment treatment gains for exposure therapy in people with PTSD. FUNDING: Australian National Health and Medical Research Council.

Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus.

BACKGROUND: The mental health burden among refugees in high-income countries (HICs) is high, whereas access to mental healthcare can be limited. OBJECTIVE: To examine the effectiveness of a peer-provided psychological intervention (Problem Management Plus; PM+) in reducing symptoms of common mental disorders (CMDs) among Syrian refugees in the Netherlands. METHODS: We conducted a single-blind, randomised controlled trial among adult Syrian refugees recruited in March 2019-December 2021 (No. NTR7552). Individuals with psychological distress (Kessler Psychological Distress Scale (K10) >15) and functional impairment (WHO Disability Assessment Schedule (WHODAS 2.0) >16) were allocated to PM+ in addition to care as usual (PM+/CAU) or CAU only. Participants were reassessed at 1-week and 3-month follow-up. Primary outcome was depression/anxiety combined (Hopkins Symptom Checklist; HSCL-25) at 3-month follow-up. Secondary outcomes included depression (HSCL-25), anxiety (HSCL-25), post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; PCL-5), impairment (WHODAS 2.0) and self-identified problems (PSYCHLOPS; Psychological Outcomes Profiles). Primary analysis was intention-to-treat. FINDINGS: Participants (n=206; mean age=37 years, 62% men) were randomised into PM+/CAU (n=103) or CAU (n=103). At 3-month follow-up, PM+/CAU had greater reductions on depression/anxiety relative to CAU (mean difference -0.25; 95% CI -0.385 to -0.122; p=0.0001, Cohen's d=0.41). PM+/CAU also showed greater reductions on depression (p=0.0002, Cohen's d=0.42), anxiety (p=0.001, Cohen's d=0.27), PTSD symptoms (p=0.0005, Cohen's d=0.39) and self-identified problems (p=0.03, Cohen's d=0.26), but not on impairment (p=0.084, Cohen's d=0.21). CONCLUSIONS: PM+ effectively reduces symptoms of CMDs among Syrian refugees. A strength was high retention at follow-up. Generalisability is limited by predominantly including refugees with a resident permit. CLINICAL IMPLICATIONS: Peer-provided psychological interventions should be considered for scale-up in HICs.

Feasibility trial of a brief scalable psychological intervention for Syrian refugee adolescents in Jordan.

Background: Most refugees are less than 18 years and at heightened risk of common mental disorders (CMDs) relative to other youth. Limited evidence exists for psychosocial programsfor youth in low-resource settings. Early Adolescent Skills for Emotions (EASE) was developed by the World Health Organization to address this gap. Objectives: This study tested the safety, feasibility, and trial procedures of the EASE intervention among Syrian refugee youth in preparation for a definitive randomized controlled trial (RCT). Methods: A feasibility RCT was conducted in Amman, Jordan with Syrian children aged 10-14 years who reported psychological distress. Following community screening, youth and their caregivers were randomized to receive either the EASE intervention or enhanced treatment as usual (ETAU). EASE comprised seven group sessions teaching children coping skills, and caregivers received three group sessions to augment the youth sessions. Assessments were conducted at baseline and 1 week following the last EASE session (8 weeks following baseline). Following the trial, a qualitative process evaluation with staff and beneficiaries took place. Primary outcomes were safety and feasibility indicators, and distress was measured by the Paediatric Symptom Checklist. Results: In November 2018, 179 children were screened; 61 (33%) met criteria for distress (34.1%), two were excluded for suicidal risk, and 59 were randomized (EASE = 33, ETAU = 26). Of those who received EASE, 26 children (79%) completed the intervention. Group attendance was high and no adverse events were reported in either arm. Psychological distress did not show signs of abating in either group over time. Conclusion: This feasibility trial demonstrated the safety and acceptability of the intervention. Important lessons were learnt regarding entry criteria into the study and engagement of caregivers in the intervention. A fully powered randomized controlled trial will be conducted to evaluate the efficacy of EASE.

Antecedentes: La mayoría de los refugiados tienen menos de 18 años y corren un mayor riesgo de padecer trastornos mentales comunes (TMC) en comparación con otros jóvenes. Existe limitada evidencia de programs psicosociales para jóvenes en entornos de bajos recursos. El program denominado Early Adolescent Skills for Emotions (EASE, por sus siglas en inglés) fue desarrollado por la Organización Mundial de la Salud con el objetivo de abordar esta brecha.Objetivos: Este estudio probó la seguridad, viabilidad y los procedimientos de la intervención EASE entre los jóvenes refugiados sirios en preparación para un ensayo controlado aleatorizado (RCT) definitivo.Métodos: Se realizó un RCT de viabilidad en Amman, Jordania, con niños sirios de 10 a 14 años que reportaron angustia psicológica. Después de la evaluación comunitaria, los jóvenes y sus cuidadores fueron asignados al azar para recibir la intervención EASE o el tratamiento como de costumbre mejorado (ETAU por sus siglas en ingles). EASE comprendió siete sesiones grupales para enseñar a los niños habilidades de afrontamiento, y los cuidadores recibieron tres sesiones grupales para potenciar las sesiones para jóvenes. Las evaluaciones se realizaron al inicio y una semana después de la última sesión de EASE (8 semanas después del inicio). Después del ensayo, se llevó a cabo una evaluación cualitativa del proceso con el personal y los beneficiarios. Los resultados principales fueron los indicadores de seguridad y viabilidad, y la angustia se midió mediante la lista de verificación de síntomas pediátricos.Resultados: En noviembre de 2018, se examinaron 179 niños; 61 (33%) cumplieron los criterios de angustia (34,1%), dos fueron excluidos por riesgo de suicidio y 59 fueron aleatorizados (EASE = 33, ETAU = 26). De los que recibieron EASE, 26 niños (79%) completaron la intervención. La asistencia al grupo fue alta y no se informaron eventos adversos en ninguno de los brazos. La angustia psicológica no mostró signos de disminuir a lo largo del tiempo en ninguno de los grupos.Conclusión: Este ensayo de viabilidad demostró seguridad y aceptabilidad de la intervención. Se aprendieron importantes lecciones con respecto a los criterios de ingreso al estudio y la participación de los cuidadores en la intervención. Se llevará a cabo un ensayo controlado aleatorizado totalmente potenciado para evaluar la eficacia de EASE.

Feasibility and acceptability of Problem Management Plus with Emotional Processing (PM+EP) for refugee youth living in the Netherlands: study protocol.

Background: Refugee youth experience hardships associated with exposure to trauma in their homelands and during and after displacement, which results in higher rates of common mental disorders. The World Health Organization (WHO) developed Problem Management Plus (PM+), a non-specialist-delivered brief psychological intervention, for individuals who have faced adversity. PM+ comprises problem-solving, stress management, behavioural activation and strengthening social support. However, it does not include an emotional processing component, which is indicated in trauma-exposed populations. Objective: This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and acceptability of PM+, adapted to Syrian, Eritrean and Iraqi refugee youth residing in the Netherlands, with and without a newly developed Emotional Processing (EP) Module. Methods: Refugee youth (N = 90) between 16 and 25 years of age will be randomized into PM+ with care-as-usual (CAU), (n = 30), PM+ with Emotional Processing (PM+EP) with CAU (n = 30) or CAU only (n = 30). Inclusion criteria are self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15) and impaired daily functioning (WHO Disability Assessment Schedule; WHODAS 2.0 > 16). Participants will be assessed at baseline, one-week post-intervention and three-month follow-up. The main outcome is the feasibility and acceptability of the adapted PM+ and PM+EP. The secondary outcomes are self-reported psychological distress, functional impairment, post-traumatic stress disorder (PTSD) symptom severity and diagnosis, social support, and self-identified problems. The pilot RCT will be succeeded by a process evaluation including trial participants, participants' significant others, helpers, and mental health professionals (n = 20) to evaluate their experiences with the PM+ and PM+EP programmes. Results and Conclusion: This is the first study that evaluates the feasibility of PM+ for this age range with an emotional processing module integrated. The results may inform larger RCTs and implementation of PM+ interventions among refugee youth. Trial Registration: Registered to Dutch Trial Registry, NL8750, on 3 July 2020. Medical Ethical Committee of the Amsterdam University Medical Centre, location Vrije Universiteit Medical Centre, Protocol ID: 2020.224, 1 July 2020.

Antecedentes: Los jóvenes refugiados experimentan dificultades relacionadas con la exposición al trauma en sus países de origen, tanto durante como después del desplazamiento. Esto resulta en tasas más elevadas de trastornos mentales comunes. La Organización Mundial de la Salud (OMS) desarrolló el programa Enfrentando Problemas Plus (EP+), una intervención psicológica breve brindada por personal no especializado para individuos que han sido expuestos a la adversidad. EP+ abarca la resolución de problemas, el manejo del estrés, la activación conductual y el fortalecimiento del soporte social. Sin embargo, no incluye un componente de procesamiento emocional, el cual es indicado en poblaciones expuestas al trauma.Objetivo: Este piloto de un ensayo clínico controlado y aleatorizado (ECA) tiene como objetivo evaluar la viabilidad y la aceptabilidad de EP+ adaptado para jóvenes refugiados sirios, eritreos e iraquíes que residen en los Países Bajos, con y sin un módulo de Procesamiento Emocional (PE) recientemente desarrollado.Métodos: Se aleatorizará a un grupo de refugiados jóvenes (N= 90) de entre 16 a 25 años a un grupo EP+ con atención habitual (AH), (n= 30), a un grupo EP+ con Procesamiento Emocional (EP+PE) con AH (n= 30), o un grupo de solamente AH (n= 30). Los criterios de inclusión son el completar los cuestionarios de autoreporte de malestar psicológico (Escala de Malestar Psicológico de Kessler; K10 >15) y de deterioro del funcionamiento diario (Cuestionario de Evaluación de la Discapacidad de la OMS; WHODAS 2.0 >16). Los participantes serán evaluados al inicio del estudio, una semana después de la intervención y a los 3 meses del seguimiento. El resultado principal es la viabilidad y aceptabilidad del programa EP+ adaptado y del EP+PE. Los resultados secundarios son el autoreporte de malestar psicológico, la discapacidad funcional, los síntomas de severidad y diagnóstico del trastorno de estrés postraumático (TEPT), el soporte social y los problemas autoidentificados. Luego de concluido el piloto del ECA, se procederá a una evaluación del proceso que incluirá a los participantes del ensayo, a las personas significativas de los participantes, a los colaboradores y a los profesionales de la salud mental (n=20) para evaluar sus experiencias con los programas EP+ y EP+PE.Resultados y conclusiones: Este es el primer estudio que evalúa la viabilidad de EP+ para este grupo de edad y con un módulo integrado de procesamiento emocional. Los resultados pueden brindar información al elaborar ECAs más grandes y a la implementación de intervenciones de EP+ entre jóvenes refugiados.

The Cultural and Contextual Adaptation Process of an Intervention to Reduce Psychological Distress in Young Adolescents Living in Lebanon.

Armed conflict leads to increased risk of emotional distress among children and adolescents, and increased exposure to significant daily stressors such as poverty and community and family violence. Unfortunately, these increased risks usually occur in the context of largely unavailable mental health services. There is growing empirical support that evidence-based treatment techniques can be adapted and delivered by non-specialists with high fidelity and effectiveness. However, in order to improve feasibility, applicability, and outcomes, appropriate cultural and contextual adaptation is essential when delivering in different settings and cultures. This paper reports the adaptation process conducted on a new World Health Organization psychological intervention-Early Adolescent Skills for Emotions (EASE)-for use in the north of Lebanon. Lebanon is a middle-income country that hosts the largest number of refugees per capita globally. We conducted: i) a scoping review of literature on mental health in Lebanon, with a focus on Syrian refugees; ii) a rapid qualitative assessment with adolescents, caregivers, community members, and health professionals; iii) cognitive interviews regarding the applicability of EASE materials; iv) a psychologist review to reach optimal and consistent Arabic translation of key terms; v) "mock sessions" of the intervention with field staff and clinical psychology experts; vi) gathering feedback from the Training of Trainers workshop, and subsequent implementation of practice sessions; and vii) gathering feedback from the Training of Facilitators workshop, and subsequent implementation of practice sessions. Several changes were implemented to the materials-some were Lebanon-specific cultural adaptations, while others were incorporated into original materials as they were considered relevant for all contexts of adversity. Overall, our experience with adaptation of the EASE program in Lebanon is promising and indicates the acceptability and feasibility of a brief, non-specialist delivered intervention for adolescents and caregivers. The study informs the wider field of global mental health in terms of opportunities and challenges of adapting and implementing low-intensity psychological interventions in settings of low resources and high adversity.

Correction to: Problem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya; study protocol for a randomized controlled trial.

[This corrects the article DOI: 10.1186/s13033-016-0075-5.].

A qualitative evaluation of a brief multicomponent intervention provided by lay health workers for women affected by adversity in urban Kenya.

BACKGROUND: Problem Management Plus (PM+) is a brief multicomponent intervention incorporating behavioral strategies delivered by lay health workers. The effectiveness of PM+ has been evaluated in randomized controlled trials in Kenya and Pakistan. When developing interventions for large-scale implementation it is considered essential to evaluate their feasibility and acceptability in addition to their efficacy. This paper discusses a qualitative evaluation of PM+ for women affected by adversity in Kenya. METHODS: Qualitative interviews were conducted with 27 key informants from peri-urban Nairobi, Kenya, where PM+ was tested. Interview participants included six women who completed PM+, six community health volunteers (CHVs) who delivered the intervention, seven people with local decision making power, and eight project staff involved in the PM+ trial. RESULTS: Key informants generally noted positive experiences with PM+. Participants and CHVs reported the positive impact PM+ had made on their lives. Nonetheless, potential structural and psychological barriers to scale up were identified. The sustainability of CHVs as unsalaried, volunteer providers was mentioned by most interviewees as the main barrier to scaling up the intervention. CONCLUSIONS: The findings across diverse stakeholders show that PM+ is largely acceptable in this Kenyan setting. The results indicated that when further implemented, PM+ could be of great value to people in communities exposed to adversities such as interpersonal violence and chronic poverty. Barriers to large-scale implementation were identified, of which the sustainability of the non-specialist health workforce was the most important one.

Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries.

The crisis in Syria has resulted in vast numbers of refugees seeking asylum in Syria's neighbouring countries as well as in Europe. Refugees are at considerable risk of developing common mental disorders, including depression, anxiety, and posttraumatic stress disorder (PTSD). Most refugees do not have access to mental health services for these problems because of multiple barriers in national and refugee specific health systems, including limited availability of mental health professionals. To counter some of challenges arising from limited mental health system capacity the World Health Organization (WHO) has developed a range of scalable psychological interventions aimed at reducing psychological distress and improving functioning in people living in communities affected by adversity. These interventions, including Problem Management Plus (PM+) and its variants, are intended to be delivered through individual or group face-to-face or smartphone formats by lay, non-professional people who have not received specialized mental health training, We provide an evidence-based rationale for the use of the scalable PM+ oriented programmes being adapted for Syrian refugees and provide information on the newly launched STRENGTHS programme for adapting, testing and scaling up of PM+ in various modalities in both neighbouring and European countries hosting Syrian refugees.

La crisis en Siria ha dado lugar a un gran número de refugiados que buscan asilo en países vecinos a Siria, así como en Europa. Los refugiados corren un riesgo considerable de desarrollar trastornos mentales comunes, como depresión, ansiedad y trastorno por estrés postraumático (TEPT). La mayoría de los refugiados no tienen acceso a servicios de salud mental para estos problemas debido a las múltiples barreras existentes en los sistemas de salud nacionales y específicos para refugiados, incluida una limitada disponibilidad de profesionales de salud mental. Para contrarrestar algunos de los retos derivados de la limitada capacidad del sistema de salud mental, la Organización Mundial de la Salud (OMS) ha desarrollado una gama de intervenciones psicológicas escalables dirigidas a reducir la angustia psicológica y mejorar el funcionamiento de las personas afectadas por la adversidad. Estas intervenciones, que incluyen Problem Management Plus (Gestión de problemas plus, PM+) y sus variantes, están pensadas para ser aplicadas en formatos cara a cara o mediante teléfonos inteligentes a individuos o grupos por personas no profesionales que no han recibido formación especializada en salud mental,Proporcionamos una justificación basada en la evidencia para el uso de programas escalables orientados a la PM+ que están siendo adaptados para refugiados sirios y proporcionamos información sobre el programa STRENGTHS recientemente lanzado para adaptar, probar y ampliar la PM+ en diversas modalidades, tanto en los países vecinos como en los europeos que reciben refugiados de Siria.

Children's Vantage Point of Recalling Traumatic Events.

This study investigated the recollections of child survivors of the 2004 Asian tsunami in terms of their vantage point and posttraumatic stress disorder (PTSD) responses. Five years after the tsunami, 110 children (aged 7-13 years) living in Aceh, Indonesia were assessed for source of memories of the tsunami (personal memory or second-hand source), vantage point of the memory, and were administered the Children's Revised Impact of Event Scale-13. Fifty-three children (48%) met criteria for PTSD. Two-thirds of children reported direct memories of the tsunami and one-third reported having memories based on reports from other people. More children (97%) who reported an indirect memory of the tsunami recalled the event from an onlooker's perspective to some extent than those who recalled the event directly (63%). Boys were more likely to rely on stories from others to reconstruct their memory of the tsunami, and to adopt an observer perspective. Boys who adopted an observer's perspective had less severe PTSD than those who adopted a field perspective. These findings suggest that, at least in the case of boys, an observer perspectives of trauma can be associated with levels of PTSD.