Tipping the scales for global mental health: A summary of the Presidential Panel at the 39th Annual Meeting of the International Society for Traumatic Stress Studies.

In the past decade, there has been an increasing focus within scientific research on how to assist people affected by the negative consequences of trauma and crises around the globe. As many countries struggle with a lack of resources to deliver mental health interventions, scalable strategies have been developed to help more people in need. These scalable strategies were the theme of the 39th annual meeting of the International Society for Traumatic Stress Studies (ISTSS). The presidential panel, chaired by Marit Sijbrandij during her ISTSS presidency, brought together a group of experts in the field of scalable interventions: Kenneth Carswell, Syed Usman Hamdani, Judy Bass, and Eirini Karyotaki. The panel highlighted the current state of the evidence on scalable interventions for adults and children and outlined important next steps for research and implementation. These recommendations include further improving the availability of, and evidence for, scalable interventions through increased training and sustained funding; conducting more studies in underrepresented samples, such as children and adolescents; and promoting open access availability of research findings worldwide. In this paper, we provide an overview of the topics discussed in the panel as well as the key takeaways.

Effectiveness of a group psychological intervention to reduce psychosocial distress in adolescents in Pakistan: a single-blind, cluster randomised controlled trial.

BACKGROUND: Emotional problems in adolescents living in low-income and middle-income countries (LMICs) remain largely unaddressed; key reasons include a scarcity of trained mental health professionals and unavailability of evidence-based, scalable psychological interventions. We aimed to evaluate the effectiveness of a non-specialist-delivered, group psychological intervention to reduce psychosocial distress in school-going adolescents in Pakistan. METHODS: In a two-arm, single-blind, cluster randomised controlled trial, eligible public school clusters from a rural subdistrict of Gujar Khan, Rawalpindi, Pakistan, were randomised (1:1, stratified by sex) using permuted block randomisation into intervention (n=20) and wait-list control (n=20) groups. Adolescents aged 13-15 years who provided informed assent and caregivers' consent were screened for psychosocial distress using the youth-reported Pediatric Symptoms Checklist (PSC; total psychosocial distress scores from 0 to 70), and those scoring 28 or more and their caregivers were enrolled into the trial. Adolescents in the intervention group received seven weekly group sessions and their caregivers received three biweekly group sessions in school settings from trained non-specialists. The primary outcome was change from baseline in the total PSC scores at 3 months post-intervention. The trial was registered prospectively with the International Standard Randomised Controlled Trial Number registry, ISRCTN17755448. FINDINGS: From the 40 school clusters that were included, 282 adolescents in the intervention group and 284 adolescents in the wait-list control group were enrolled between Nov 2 and Nov 30, 2021. At 3 months, adolescents in the intervention group had significantly lower mean total score on the PSC compared with adolescents in the control group (mean difference in change from baseline 3·48 [95% CI 1·66-5·29], p=0·0002, effect size 0·38 [95% CI 0·18-0·57]; adjusted mean difference 3·26 (95% CI 1·46-5·06], p=0·0004, effect size 0·35 (0·16-0·55). No adverse events were reported in either group. INTERPRETATION: The group psychological intervention most likely represents a feasible and effective option for adolescents with psychosocial distress in school settings. FUNDING: UK Medical Research Council, Foreign Commonwealth and Development Office, Department of Health and Social Care. TRANSLATION: For the Urdu translation of the abstract see Supplementary Materials section.

Technology-assisted task-sharing to bridge the treatment gap for childhood developmental disorders in rural Pakistan: an implementation science case study.

BACKGROUND: As in many low-income countries, the treatment gap for developmental disorders in Pakistan is nearly 100%. The World Health Organization (WHO) has developed the mental Health Gap Intervention guide (mhGAP-IG) to train non-specialists in the delivery of evidence-based mental health interventions in low-resource settings. However, a key challenge to scale-up of non-specialist-delivered interventions is designing training programs that promote fidelity at scale in low-resource settings. In this case study, we report the experience of using a tablet device-based application to train non-specialist, female family volunteers in leading a group parent skills training program, culturally adapted from the mhGAP-IG, with fidelity at scale in rural community settings of Pakistan. METHODS: The implementation evaluation was conducted as a part of the mhGAP-IG implementation in the pilot sub-district of Gujar Khan. Family volunteers used a technology-assisted approach to deliver the parent skills training in 15 rural Union Councils (UCs). We used the Proctor and RE-AIM frameworks in a mixed-methods design to evaluate the volunteers' competency and fidelity to the intervention. The outcome was measured with the ENhancing Assessment of Common Therapeutic factors (ENACT), during training and program implementation. Data on other implementation outcomes including intervention dosage, acceptability, feasibility, appropriateness, and reach was collected from program trainers, family volunteers, and caregivers of children 6 months post-program implementation. Qualitative and quantitative data were analyzed using the framework and descriptive analysis, respectively. RESULTS: We trained 36 volunteers in delivering the program using technology. All volunteers were female with a mean age of 39 (± 4.38) years. The volunteers delivered the program to 270 caregivers in group sessions with good fidelity (scored 2.5 out of 4 on each domain of the fidelity measure). More than 85% of the caregivers attended 6 or more of 9 sessions. Quantitative analysis showed high levels of acceptability, feasibility, appropriateness, and reach of the program. Qualitative results indicated that the use of tablet device-based applications, and the cultural appropriateness of the adapted intervention content, contributed to the successful implementation of the program. However, barriers faced by family volunteers like community norms and family commitments potentially limited their mobility to deliver the program and impacted the program' reach. CONCLUSIONS: Technology can be used to train non-specialist family volunteers in delivering evidence-based intervention at scale with fidelity in low-resource settings of Pakistan. However, cultural and gender norms should be considered while involving females as volunteer lay health workers for the implementation of mental health programs in low-resource settings.

Improving psychosocial distress for young adolescents in rural schools of Pakistan: study protocol of a cluster randomised controlled trial.

INTRODUCTION: Emotional problems are leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people. This study aims to evaluate the effectiveness of a school-based, group psychological intervention, Early Adolescent Skills for Emotions (EASE) developed by the WHO to improve psychosocial distress in Pakistani adolescents. METHOD AND ANALYSIS: A two-arm, single-blinded, cluster randomised controlled trial, with a wait-list control arm is being conducted in school settings of rural Pakistan. Forty eligible public-school clusters have been randomised (stratified by gender) on a 1:1 allocation ratio into intervention (n=20) and control arm (n=20). Following informed consent, 564 adolescents with psychosocial distress (Youth-reported Paediatric Symptoms Checklist, cut-off ≥28) from 40 schools have been enrolled into the trial (14±3 average cluster size) between 2 November 2021 and 30th November 2021. Participants in the intervention arm will receive EASE in 7-weekly adolescents and 3-biweekly caregivers group sessions in schools. The adolescent sessions involve the components of psychoeducation, stress management, behavioural activation, problem-solving and relapse prevention. Caregivers will receive training to learn and implement active listening; spending quality time and using praise as a strategy to help their children. The primary outcome is reduction in psychosocial distress at 3 months postintervention. Secondary outcomes include symptoms of depression and anxiety, caregiver-adolescent relationship and caregivers' well-being. Outcomes will be assessed at baseline, immediate 1 week and 3-months postintervention. Qualitative process evaluation will explore barriers and facilitators to programme implementation in low-resource school settings. ETHICS: Ethics approval has been obtained from Central Ethics Committee of University of Liverpool, UK, Ethics Review Committee of WHO Geneva and from the Institutional Review Board of Human Development Research Foundation (HDRF), Pakistan. DISSEMINATION: The findings of the study will be disseminated by WHO and through peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN17755448.

Feasibility and acceptability of a multicomponent, group psychological intervention for adolescents with psychosocial distress in public schools of Pakistan: a feasibility cluster randomized controlled trial (cRCT).

BACKGROUND: Child and adolescent mental health problems are a global public mental health priority. However, there is a lack of evidence-based scalable psychological interventions for adolescents living in low resource settings. This trial was designed to evaluate the feasibility and acceptability of delivering the World Health Organization's Early Adolescent Skills for Emotions (EASE) intervention at public schools in a rural sub-district in Rawalpindi, Pakistan. METHODS: A two arm, single blinded, feasibility cluster randomized controlled trial with mixed-methods evaluation was conducted with 59 adolescents and their caregivers from 8 public schools. In the 4 intervention arm schools, 6 non-specialist facilitators delivered the culturally-adapted EASE group sessions to the adolescents (n = 29) and their caregivers with desired fidelity under the supervision of in-country supervisors. RESULTS: The participation rate of adolescents in the intervention sessions was 83%. The intervention strategies were implemented by the adolescents. However, attending biweekly sessions at schools was challenging for caregivers with only 50% caregivers attending the sessions. CONCLUSIONS: The results of this study support the feasibility and acceptability of delivering this culturally adapted intervention through non-specialist facilitators in school settings in Pakistan and pave the way to conduct a fully powered cluster randomized controlled trial to test the effectiveness of intervention to improve psychological outcomes in adolescents. Trial registration Trial registered with Clinicaltrials.gov prospectively; NCT04254393.

Effectiveness of relaxation techniques 'as an active ingredient of psychological interventions' to reduce distress, anxiety and depression in adolescents: a systematic review and meta-analysis.

BACKGROUND: Adolescent depression and anxiety are among the leading contributors to health burden worldwide. 'Relaxation Techniques (RTs)' are a "set of strategies to improve physiological response to stress" and are frequently cited as an active ingredient of trans-diagnostic, psychosocial interventions for scaling-up care for preventing and treating these conditions in adolescents. However, there is a little evidence on the effectiveness of 'relaxation techniques' for this age group. AIM: As a part of the Wellcome Trust's Active Ingredients commission, we did a systematic review and meta-analysis to evaluate the effectiveness of RTs to reduce the symptoms of distress, anxiety and depression in young people, aged 14 to 24 years old, globally. METHODS: We searched 10 academic databases to include 65 Randomized Controlled Trials (RCTs) of relaxation-based interventions for young people with the symptoms of anxiety and depression. Primary outcomes were reduction in symptoms of distress, anxiety and/or depression. We employed the Cochrane risk of bias tool and GRADE (Grading of Recommendations, Assessment, Development and Evaluations) guidelines to assess certainty of outcomes pertaining to anxiety, depression and distress. Standardized mean difference was estimated using effect size. RESULTS: The analysis of 65 RCTs with 8009 young people showed that RTs were highly effective in treating anxiety (pooled effect size of (Standardized Mean Difference-SMD) - 0.54 (95% CI - 0.69 to - 0.40); moderately effective in reducing distress (SMD = - 0.48, 95% CI - 0.71 to - 0.24) and had only a weak effect on improving depression in young people (SMD = - 0.28 (95% CI - 0.40% to - 0.15). Face-to-face delivered relaxation techniques yielded higher effect size (SMD = - 0.47, 95% CI - 0.64 to - 0.30) compared to online delivery (SMD = - 0.22, 95% CI - 0.48 to 0.04) for anxiety. CONCLUSION: Most of the included studies were from High Income Countries (HICs) and had a high risk of bias. Further high-quality studies with low risk of bias, especially from low resource settings are needed to evaluate the evidence for effectiveness of RTs as an active ingredient of psychological interventions to reduce the symptoms of distress, anxiety and depression in young people.

A comparison of real-world effectiveness of vortioxetine along the treatment algorithm for major depressive disorder.

OBJECTIVE: To evaluate the effectiveness of vortioxetine in major depressive disorder (MDD) when used as a first-line versus second-line treatment or later. METHODS: This was a post-hoc analysis of three 3-month non-interventional, prospective studies of vortioxetine in MDD - REVIDA (Malaysia, Philippines, Singapore, Thailand), PREVIDA (Pakistan) and TREVIDA (Taiwan). Improvements in depressive symptoms (PHQ-9, CGI-S), cognitive function (PDQ-D) and work productivity (WPAI) were compared between studies, and in a pooled analysis of patients using vortioxetine as the first line versus second-line treatment or later. Safety was compared between studies. RESULTS: Overall, 798 patients were analyzed (PREVIDA = 425, REVIDA = 130, TREVIDA = 243). Most patients in PREVIDA (60.5%)/REVIDA (57.4%) used vortioxetine as first-line treatment versus TREVIDA (21.8%). Generally, greater improvements from baseline were observed across outcome measures in PREVIDA/REVIDA versus TREVIDA (Month 3, p < .0001). Vortioxetine as first-line treatment was associated with greater improvements in depression severity, cognition, functioning outcomes compared to second-line or later users (PHQ-9: -16.1 [6.4] vs -10.8 [8.9]; CGI-S: -2.7 [1.1] vs -2.0 [1.4]; PDQ-D: -29.5 [17.7] vs -18.5 [21.4]; p < .0001 at Month 3) as well as greater response (PHQ-9: 88.6% vs 61.5%; p < .0001) and remission rates (PHQ-9: 75.4% vs 47.7%; p < .0001). No new adverse events were reported outside of the product label. CONCLUSIONS: In the Asian real-world setting, vortioxetine showed greater improvements in depressive and cognitive symptoms, work functioning, and response and remission rates when used as first-line versus second-line treatment or later. Vortioxetine was well-tolerated irrespective of the study population across Asia.

Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis.

BACKGROUND: To address shortages of mental health specialists in low- and middle-income countries, task-shifting approaches have been employed to train nonspecialists to deliver evidence-based scalable psychosocial interventions. Problem Management Plus (PM+) is a brief transdiagnostic nontrauma focused intervention for people affected by adversity. This study reports on the capacity of PM+ to address specific symptoms of posttraumatic stress disorder (PTSD). METHODS: Individual patient data from three randomised controlled trials were combined and analysed to observe the impacts of PM+ (n = 738) or enhanced treatment as usual (ETAU) (n = 742) interventions on specific PTSD symptoms at posttreatment and 3-month follow-up. The PTSD-Checklist for DSM-5 (PCL-5) was used to index PTSD symptoms, and presence of each symptom was defined as moderate severity (score ≥ 2 on individual items). RESULTS: The average PCL-5 score at baseline was 26.1 (SD: 16.8) with 463 (31.3%) scoring above 33, indicative of a diagnosis of PTSD. Following intervention, 12.5% and 5.8% of participants retained a score greater than 33 at postassessment and follow-up, respectively. There was greater symptom reduction for PM+ than for ETAU for most symptoms. Hyperarousal symptoms were the most common residual symptoms after PM+, with more than 30% of participants reporting persistent sleep disturbance, concentration difficulties, and anger. CONCLUSION: PM+ led to greater reduction in symptoms relating to re-experiencing and avoidance. The evidence indicates that strategies focusing on hyperarousal symptoms including sleep, concentration, and anger difficulties, could be strengthened in this brief intervention.

Preparing for parenthood: developing a life-skills and socioemotional health program for young married couples in rural Pakistan.

BACKGROUND: Socioemotional life-skills to negotiate important life-transitions such as marriage and parenthood are critical for the wellbeing of young couples and their offspring, but programs addressing this issue are lacking in Low and Middle-Income Countries (LMICs). OBJECTIVE: This study describes the development of a 'life-skills' program for young married women, their husbands and families, living in rural settings in Pakistan. METHODS: Our methods included: a) a targeted review of relevant literature on life-skills and mental health in young people, b) a qualitative study and, c) intervention development workshops with experts and stakeholders. The review showed that common life-skills employed as part of psychosocial interventions in LMICs were communication skills, problem-solving, assessing relations, stress management, emotional regulation, identifying/eliciting affect, and self-awareness. RESULTS: The qualitative study indicated that areas of particular need included interpersonal communication skills with significant others, coping with the pressures of parenthood, and mental well-being. Existing helpful practices included social support by family members and elders. Lack of empowerment in young married women and poor engagement of husbands were identified as a barrier to accessing a potential intervention. Our proposed intervention called 'Preparing for Parenthood' consisted of 10 core sessions and 10 follow-up sessions designed to be delivered by lay health workers. It synergistically combined evidence-based socioemotional life-skills (awareness, communication skills, assertiveness, decision-making skills, goal-setting, critical thinking, problem-solving, and coping with stress), with cognitive behavioural strategies (gently challenging existing thoughts and attitudes, behaviour activation and problem solving). The intervention focuses on engagement of the entire family, including husbands. CONCLUSIONS: The intervention can supplement existing sexual and reproductive health programs by providing skills to prospective parents to effectively negotiate stressful life-transitions and life-events. We envisage the intervention would improve mental as well as sexual and reproductive health of young couples and plan to test this in future randomised trials.

Evaluating the impact of a common elements-based intervention to improve maternal psychological well-being and mother-infant interaction in rural Pakistan: study protocol for a randomised controlled trial.

INTRODUCTION: Millions of children in low resource settings are at high risk of poor development due to factors such as under nutrition, inadequate stimulation and maternal depression. Evidence-based interventions to address these risk factors exist, but often as a separate and overlapping package. The current study aims to evaluate the effectiveness of a common elements-based intervention to improve mother-infant interaction at 12 months post-partum. METHOD AND ANALYSIS: A two-arm, single-blinded, individual randomised controlled trial is being carried out in the community settings of the rural subdistrict of Gujar Khan in Rawalpindi, Pakistan. 250 pregnant women in third trimester with distress (Self-Reporting Questionnaire, cut-off score >9) have been randomised on 1:1 allocation ratio into intervention (n=125) and treatment-as-usual arms (n=125). The participants in the intervention arm will receive 15 individual sessions of intervention on a monthly basis by non-specialist facilitators. The intervention involves components of early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem solving. The primary outcome is caregiver-infant interaction at 12 months postpartum. The secondary outcomes include maternal psychological well-being, quality of life, social support and empowerment. Infant secondary outcomes include growth, nutrition and development. The data will be collected at baseline, 6 and 12 months postpartum. A qualitative process evaluation will be conducted to inform the feasibility of intervention delivery. ETHICS: Ethics approval for the present study was obtained from the Human Development Research Foundation Institutional Review Board, Islamabad Pakistan. DISSEMINATION: If proven effective, the study will contribute to scale-up care for maternal and child mental health in low resource settings, globally. The findings of the present study will be published in peer-reviewed journals and presented at conferences and community forums. TRIAL REGISTRATION NUMBER: NCT04252807.

Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial.

BACKGROUND: Globally, there is a large documented gap between needs of families and children with developmental disorders and available services. We adapted the World Health Organization's mental health Gap-Intervention Guidelines (mhGAP-IG) developmental disorders module into a tablet-based android application to train caregivers of children with developmental disorders. We aimed to evaluate the effectiveness of this technology-assisted, family volunteers delivered, parents' skills training intervention to improve functioning in children with developmental disorders in a rural community of Rawalpindi, Pakistan. METHODS: In a single-blinded, cluster randomized controlled trial, 30 clusters were randomised (1:1 ratio) to intervention (n = 15) or enhanced treatment as usual (ETAU) arm (n = 15). After screening, 540 children (18 participants per cluster) aged 2-12 years, with developmental disorders and their primary caregivers were recruited into the trial. Primary outcome was child's functioning, measured by Childhood Disability Assessment Schedule for Developmental Disorders (DD-CDAS) at 6-months post-intervention. Secondary outcomes were parents' health related quality of life, caregiver-child joint engagement, socio-emotional well-being of children, family empowerment and stigmatizing experiences. Intention-to-treat analyses were done using mixed-models adjusted for covariates and clusters. RESULTS: At 6-months post-intervention, no statistically significant mean difference was observed on DD-CDAS between intervention and ETAU (mean [SD], 47.65 [26.94] vs. 48.72 [28.37], Adjusted Mean Difference (AMD), - 2.63; 95% CI - 6.50 to 1.24). However, parents in the intervention arm, compared to ETAU reported improved health related quality of life (mean [SD] 65.56 [23.25] vs. 62.17 [22.63], AMD 5.28; 95% CI 0.44 to 10.11). The results were non-significant for other secondary outcomes. CONCLUSIONS: In the relatively short intervention period of 6 months, no improvement in child functioning was observed; but, there were significant improvements in caregivers' health related quality of life. Further trials with a longer follow-up are recommended to evaluate the impact of intervention. Trial registration Clinicaltrials.gov, NCT02792894. Registered April 4, 2016, https://clinicaltrials.gov/ct2/show/NCT02792894.

Annual Research Review: Achieving universal health coverage for young children with autism spectrum disorder in low- and middle-income countries: a review of reviews.

BACKGROUND: Autism presents with similar prevalence and core impairments in diverse populations. We conducted a scoping review of reviews to determine key barriers and innovative strategies which can contribute to attaining universal health coverage (UHC), from early detection to effective interventions for autism in low- and middle-income countries (LAMIC). METHODS: A systematic literature search of review articles was conducted. Reviews relevant to the study research question were included if they incorporated papers from LAMIC and focused on children (

Debate: Child and adolescent mental health services in Pakistan; Do we need in-patient mental health facilities for children and young people?

Depression and anxiety are leading causes of morbidity in children and adolescents worldwide. In Pakistan, young people are exposed to many chronic adversities including violence, social and economic inequalities, and are at greater risk of developing mental health problems. Yet there is a lack of trained human resources, in-patient child and adolescent mental healthcare facilities, and training opportunities in child and adolescent psychiatry and mental health in Pakistan. Given the poor economic condition of the country, which has been made even worse by the COVID-19 pandemic, it is very unlikely that dedicated resources will be made available in near future to develop specialist child and adolescent mental health services in Pakistan. To bridge this treatment gap, we propose a multitiered, transdiagnostic, task-shifting strategy-based model for child and adolescent mental health services in Pakistan.

Scaling-up school mental health services in low resource public schools of rural Pakistan: the Theory of Change (ToC) approach.

BACKGROUND: Ninety percent of children with mental health problems live in low or middle-income countries (LMICs). School-based programs offer opportunities for early identification and intervention, however implementation requires cross-sector collaboration to assure sustainable delivery of quality training, ongoing supervision, and outcomes monitoring at scale. In Pakistan, 35% of school-aged children are reported to have emotional and behavioral problems. As in many other LMICs, the government agencies who must work together to mount school-based programs have limited resources and a limited history of collaboration. The "Theory of Change" (ToC) process offers a way for new partners to efficiently develop mutual goals and long-term prospects for sustainable collaboration. OBJECTIVE: Develop a model for scale-up of school based mental health services in public schools of Pakistan. METHODS: We used ToC workshops to develop an empirically supported, 'hypothesized pathway' for the implementation of WHO's School Mental Health Program in the public schools of rural Pakistan. Three workshops included 90 stakeholders such as policy makers from education and health departments, mental health specialists, researchers, head teachers, teachers and other community stakeholders including non-governmental organizations. RESULTS: The ToC process linked implementers, organizations, providers and consumers of school mental health services to develop common goals and relate them (improved child socioemotional wellbeing, grades and participation in activities) to interventions (training, monitoring and supervision of teachers; collaboration with parents, teachers and primary health care facilities and schools). Key testable assumptions developed in the process included buy-in from health care providers, education officials and professionals, community-based organizations and families. For example, teachers needed skills for managing children's problems, but their motivation might come from seeking improved school performance and working conditions. Poverty, stigma and lack of child mental health literacy among teachers, administration, and parents were identified as key hypothesized barriers. Children and their families were identified as key stakeholders to make such a program successful. DISCUSSION: ToC workshops assisted in team building and served as a stakeholders' engagement tool. They helped to develop and support testable hypotheses about the structures, collaborations, and knowledge most important to scaling-up school based mental health services in Pakistan.

Effect of adding a psychological intervention to routine care of common mental disorders in a specialized mental healthcare facility in Pakistan: a randomized controlled trial.

BACKGROUND: In many low resource settings, the provision of government mental health care services is limited to specialized psychiatry units in urban hospital care facilities, where the most common treatment for common mental disorders (CMDs) is pharmacotherapy, occasionally with adjunct nonspecific psychological support. We aimed to evaluate the effectiveness of adding a low intensity, psychological intervention, Problem Management Plus (PM+) for CMDs into routine care in a specialized mental health care facility in Pakistan. METHODS: A two arm, single-blind individual randomized controlled trial (RCT) was carried out with adults (N = 192), referred for psychological support by psychiatrists. The study participants were randomized (1:1) to PM + plus Treatment as Usual (TAU) (n = 96) or TAU only (n = 96). The primary outcomes were symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) and functional impairment as measured by WHO Disability Assessment Schedule (WHODAS 2.0) at 20 weeks after baseline. RESULTS: The analysis was done on intention-to-treat principle. The linear mixed model analysis showed that at 20 weeks after baseline, there was a significant reduction in symptoms of anxiety and depression (mean [SD], 16.23 [8.81] vs 19.79 [7.77]; AMD, - 3.10; 95% CI, - 0.26 to - 5.76); p = 0.03 and improvement in functioning (mean [SD], 22.94 [9.37] vs 27.37 [8.36]; AMD, - 4.35; 95% CI, - 1.45 to - 7.24); p = 0.004 in PM + plus TAU versus TAU arm. The follow-up rate was 67% at primary end-point. CONCLUSIONS: Specialized care facilities in LMICs may consider adding brief, evidence-based psychological treatments for CMDs to their routine care. Trial Registration Australian New Zealand Clinical Trials Registry, ACTRN12616000381482. Registered March 23, 2016. Retrospectively registered, https://www.anzctr.org.au/Default.aspx/ ACTRN12616000381482.

Addressing the Consequences of the COVID-19 Lockdown for Children's Mental Health: Investing in School Mental Health Programs.

Children are likely to struggle with mental health consequences relating to the COVID-19 pandemic. School closures and home confinement increase the risk for emotional distress, domestic violence and abuse, and social isolation, as well as for disruption of sleep-wake and meal cycles, physical exercise routines, and health care access. As schools reopen, school mental health programs (SMHPs) incorporating universal approaches will be important for all children, and targeted approaches will be necessary for those more severely affected. Using their experience in Pakistan, the authors provide a roadmap for extending the World Health Organization's eastern Mediterranean region's SMHP to address the mental health consequences of COVID-19 among children globally.

Debate: Implementation Science can help bridge the gap between evidence and policy - a case study from the Eastern Mediterranean Region.

The burden from mental disorder in the Eastern Mediterranean Region (EMR) has risen steadily over the last three decades. The unmet need for interventions puts pressure on policymakers for urgent action, often leading to the introduction of programmes developed in high-income countries, with very little attention to how well these meet local needs. Till well-designed local research including randomised controlled trials become common practice in low- and middle-income countries, implementation science could provide relatively cheaper and quicker ways of ensuring that these interventions do indeed lead to patient benefit. We present a case study of a teacher-delivered school mental health intervention developed by international experts, and implemented in the EMR under the auspices of the World Health Organization. We used an implementation research framework to adapt the programme to local needs, obtain stakeholder buy-in, and design an online-training programme for rapid dissemination in local schools in Egypt, Iran, Jordan and Pakistan. Within the official roll-out of the programme in one EMR country (Pakistan), we embedded a hybrid effectiveness-implementation cluster randomised control trial to evaluate both clinical and implementation outcomes of the adapted intervention. The approach allows for rapid adaptation and evidence building within real-world implementation settings. Capacity in low- and middle-income countries for such research needs to be developed.

Technology-Assisted Teachers' Training to Promote Socioemotional Well-Being of Children in Public Schools in Rural Pakistan.

BACKGROUND: The World Health Organization's (WHO) Eastern Mediterranean Regional Office (EMRO) developed a school mental health program (SMHP) to help reduce the burden of youth mental health problems. Designed in collaboration with international consultants, the SMHP draws on evidence-based interventions to train personnel to identify students in need, respond therapeutically, and engage families in seeking care. METHODS: Teams from Pakistan, Egypt, Iran, and Jordan collaborated with the WHO EMRO and British and U.S. universities to form the School Health Implementation Network: Eastern Mediterranean Region (SHINE), a National Institute of Mental Health-funded global mental health hub. SHINE partners used a "theory of change" process to adapt the SMHP to be more readily adopted by school personnel and replicated with fidelity. The adapted SMHP more directly addresses teachers' priorities and uses technology to facilitate training. RESULTS: A cluster-randomized implementation effectiveness trial enrolling 960 children ages 8-13 in 80 Pakistani schools will test the adapted SMHP against the original. Children who screen positive on first the teacher and subsequently the parent Strengths and Difficulties Questionnaires (SDQs) will be enrolled and tracked for 9 months. The primary trial outcome is reduction in parent-rated SDQ total difficulties scores. Secondary outcomes include children's well-being, academic performance, absenteeism, and perceived stigma; parent-teacher interaction; teachers' self-efficacy and subjective well-being; and school environment. Implementation outcomes include change in teachers' behavior and sense of program acceptability, cultural appropriateness, feasibility, penetration, and sustainability. NEXT STEPS: The trial began in October 2019, and the expected completion date is March 2021. Outcomes will inform dissemination of the SMHP in Pakistan and elsewhere.

Improving mental health and psychosocial wellbeing in humanitarian settings: reflections on research funded through R2HC.

Major knowledge gaps remain concerning the most effective ways to address mental health and psychosocial needs of populations affected by humanitarian crises. The Research for Health in Humanitarian Crisis (R2HC) program aims to strengthen humanitarian health practice and policy through research. As a significant portion of R2HC's research has focused on mental health and psychosocial support interventions, the program has been interested in strengthening a community of practice in this field. Following a meeting between grantees, we set out to provide an overview of the R2HC portfolio, and draw lessons learned. In this paper, we discuss the mental health and psychosocial support-focused research projects funded by R2HC; review the implications of initial findings from this research portfolio; and highlight four remaining knowledge gaps in this field. Between 2014 and 2019, R2HC funded 18 academic-practitioner partnerships focused on mental health and psychosocial support, comprising 38% of the overall portfolio (18 of 48 projects) at a value of approximately 7.2 million GBP. All projects have focused on evaluating the impact of interventions. In line with consensus-based recommendations to consider a wide range of mental health and psychosocial needs in humanitarian settings, research projects have evaluated diverse interventions. Findings so far have both challenged and confirmed widely-held assumptions about the effectiveness of mental health and psychosocial interventions in humanitarian settings. They point to the importance of building effective, sustained, and diverse partnerships between scholars, humanitarian practitioners, and funders, to ensure long-term program improvements and appropriate evidence-informed decision making. Further research needs to fill knowledge gaps regarding how to: scale-up interventions that have been found to be effective (e.g., questions related to integration across sectors, adaptation of interventions across different contexts, and optimal care systems); address neglected mental health conditions and populations (e.g., elderly, people with disabilities, sexual minorities, people with severe, pre-existing mental disorders); build on available local resources and supports (e.g., how to build on traditional, religious healing and community-wide social support practices); and ensure equity, quality, fidelity, and sustainability for interventions in real-world contexts (e.g., answering questions about how interventions from controlled studies can be transferred to more representative humanitarian contexts).