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Abstract Background Depression is a prevalent mental health condition worldwide but there is limited data on its presentation and associated symptoms in primary care settings in low- and middle-income countries like Nepal. This study aims to assess the prevalence of depression, its hallmark and other associated symptoms that meet the Diagnostic and Statistical Manual (DSM-5) criteria in primary healthcare facilities in Nepal. The collected information will be used to determine the content of a mobile app-based clinical guidelines for better detection and management of depression in primary care. Methods A total of 1,897 adult patients aged 18–91 (63.1% women) attending ten primary healthcare facilities in Jhapa, a district in eastern Nepal, were recruited for the study between August 2, 2021, and March 25, 2022. Trained research assistants conducted face-to-face interviews in private spaces before the consultation with healthcare providers. Depression symptoms, including hallmark symptoms, was assessed using the validated Nepali version of the Patient Health Questionnaire (PHQ-9). Results One in seven (14.5%) individuals attending primary health care facilities in Jhapa met the threshold for depression based on a validated cut-off score ( > = 10) on the PHQ-9. The most commonly reported depressive symptoms were loss of energy and sleep difficulties. Approximately 25.4% of women and 18.9% of men endorsed at least one of the two hallmark symptoms on the PHQ-9. Using a DSM-5 algorithm (at least one hallmark symptom and five or more total symptoms) to score the PHQ-9, 6.3% of women and 4.3% of men met the criteria for depression. The intra-class correlation coefficient for PHQ-9 total scores by health facility as the unit of clustering was 0.01 (95% confidence interval, 0.00-0.04). Conclusion Depression symptoms are common among people attending primary healthcare facilities in Nepal. However, the most common symptoms are not the two hallmark criteria. Use of total scores on a screening tool such as the PHQ-9 risks overestimating the prevalence and generating false positive diagnoses. Compared to using cut off scores on screening tools, training health workers to first screen for hallmark criteria may increase the accuracy of identification and lead to better allocation of treatment resources.

Abstract Background Despite the high burden of perinatal depression in Nepal, the detection rate is low. Community-based strategies such as sensitization programmes and the Community Informant Detection Tool (CIDT) have been found to be effective in raising awareness and thus promoting the identification of mental health problems. This study aims to adapt these community strategies for perinatal depression in the Nepalese context. Methods We followed a four-step process to adapt the existing community sensitization program manual and CIDT. Step 1 included in-depth interviews with women identified with perinatal depression (n=36), and focus group discussions were conducted with health workers trained in community mental health (n=13), female community health volunteers (FCHVs), cadre of Nepal government for the prevention and promotion of community maternal and child health (n=16), and psychosocial counsellors (n=5). We explored idioms and understanding of depression, perceived causes, and possible intervention. Step 2 included draft preparation based on the qualitative study. Step 3 included a one-day workshop with the psychosocial counsellors (n=2) and health workers (n=12) to assess the understandability and comprehensiveness of the draft and to refine the content. A review of the CIDT and community sensitization program manual by a psychiatrist was performed in Step 4. Results The first step led to the content development for the CIDT and community sensitization manual. Multiple stakeholders and experts reviewed and refined the content from the second to fourth steps. Idioms of depression and commonly cited risk factors were incorporated in the CIDT. Additionally, myths of perinatal depression and the importance of the role of family were added to the community sensitization manual. Conclusion Both the CIDT and community sensitization manual are grounded in the local context and are simple, clear, and easy to understand.

Abstract Background Globally, there is a vast mental health treatment gap, whereby the majority of adolescents living in low- and middle-income countries requiring mental health services, do not have access to adequate care. To improve access, the World Health Organization (WHO) developed a range of interventions, designed to be low-cost and delivered by non-specialists. We conducted a two-arm, individually randomised group treatment feasibility trial of a new WHO group intervention for young adolescents with emotional distress (‘Early Adolescent Skills for Emotions’; EASE) in Lebanon. Method The aim of this study was to determine the feasibility of the intervention and study procedures. Adolescents aged 10 to 14 years were eligible to take part if they scored above a validated cut-off on the Child Psychosocial Distress Screener. Participants were randomized to EASE or enhanced treatment as usual (ETAU) control using a 1:1 ratio. EASE consisted of seven group sessions with adolescents and three sessions with caregivers. ETAU consisted of a single brief psychoeducation home visit. Child and caregiver outcomes were measured by blind assessors at baseline, endline (8 weeks post-randomisation), and three month follow-up (20 weeks post-randomisation), with the primary outcome measure being child psychological symptoms on the Pediatric Symptom Checklist. Qualitative interviews were conducted with adolescents (n = 13), caregivers (n = 17), facilitators (n = 6), trainers (n = 3), and outreach staff (n = 1) at endline to assess barriers and facilitators related to the feasibility and delivery of EASE and study procedures. Results Of 154 adolescents screened, 67 (43%) were eligible, completed baseline, and were randomized. Sixty adolescents (90%) completed endline assessments (31 EASE, 29 ETAU), and fifty-nine (88%) completed three-month assessments (29 EASE, 30 ETAU). Qualitatively, participants provided overall positive feedback about the intervention. Several challenges and suggestions for improvement were raised around logistics, intervention content, and acceptability of assessment measures. Implementation data highlighted challenges with intervention uptake and attendance. Outcome measures generally had strong psychometric properties (range: α = 0.77 to α = 87), however did not demonstrate change over time in either group. Conclusions The EASE intervention and study procedures are acceptable and feasible for implementation with vulnerable adolescents in Lebanon, however several improvements are necessary prior to full-scale evaluation. Trial registration #ISRCTN60799626, retrospectively registered on 04/10/2022.

Abstract Background Integrating mental health services into primary care is a key strategy for reducing the mental healthcare treatment gap in low- and middle-income countries. We examined healthcare use and costs over time among individuals with depression and subclinical depressive symptoms in Chitwan, Nepal to understand the impact of integrated care on individual and health system resources. Methods Individuals diagnosed with depression at ten primary care facilities were randomized to receive a package of integrated care based on the Mental Health Gap Action Programme (treatment group; TG) or this package plus individual psychotherapy (TG + P); individuals with subclinical depressive symptoms received primary care as usual (UC). Primary outcomes were changes in use and health system costs of outpatient healthcare at 3- and 12-month follow up. Secondary outcomes examined use and costs by type. We used Poisson and log-linear models for use and costs, respectively, with an interaction term between time point and study group, and with TG as reference. Results The study included 192 primary care service users (TG = 60, TG + P = 60, UC = 72; 86% female, 24% formally employed, mean age 41.1). At baseline, outpatient visits were similar (− 11%, p = 0.51) among TG + P and lower (− 35%, p = 0.01) among UC compared to TG. Visits increased 2.30 times (p

Abstract Background There are increasing initiatives to reduce mental illness stigma among primary care providers (PCPs) being trained in mental health services. However, there is a gap in understanding how stigma reduction initiatives for PCPs produce changes in attitudes and clinical practices. We conducted a pilot randomized controlled trial of a stigma reduction intervention in Nepal: REducing Stigma among HealthcAre Providers (RESHAPE). In a previous analysis of this pilot, we described differences in stigmatizing attitudes and clinical behaviors between PCPs receiving a standard mental health training (mental health Gap Action Program, mhGAP) vs. those receiving an mhGAP plus RESHAPE training. The goal of this analysis is to use qualitative interview data to explain the quantitative differences in stigma outcomes identified between the trial arms. Methods PCPs were randomized to either standard mental health training using mhGAP led by mental health specialists or the experimental condition (RESHAPE) in which service users living with mental illness shared photographic recovery narratives and participated in facilitated social contact. Qualitative interviews were conducted with PCPs five months post-training (n = 8, standard mhGAP training; n = 20, RESHAPE). Stigmatizing attitudes and clinical practices before and after training were qualitatively explored to identify mechanisms of change. Results PCPs in both training arms described changes in knowledge, skills, and confidence in providing mental healthcare. PCPs in both arms described a positive feedback loop, in which discussing mental health with patients encouraged more patients to seek treatment and open up about their illness, which demonstrated for PCPs that mental illness can be treated and boosted their clinical confidence. Importantly, PCPs in the RESHAPE arm were more likely to describe a willingness to treat mental health patients and attributed this in part to social contact with service users during the training. Conclusions Our qualitative research identified testable mechanisms of action for stigma reduction and improving clinical behavior: specifically, recovery stories from service users and social engagement led to greater willingness to engage with patients about mental illness, triggering a feedback loop of more positive experiences with patients who benefit from mental healthcare, which further reinforces willingness to deliver mental healthcare. Trial registration ClinicalTrials.gov identifier, NCT02793271

Abstract Background There are increasing efforts for the integration of mental health services into primary care settings in low- and middle-income countries. However, commonly used approaches to train primary care providers (PCPs) may not achieve the expected outcomes for improved service delivery, as evidenced by low detection rates of mental illnesses after training. One contributor to this shortcoming is the stigma among PCPs. Implementation strategies for training PCPs that reduce stigma have the potential to improve the quality of services. Design In Nepal, a type 3 hybrid implementation-effectiveness cluster randomized controlled trial will evaluate the implementation-as-usual training for PCPs compared to an alternative implementation strategy to train PCPs, entitled Reducing Stigma among Healthcare Providers (RESHAPE). In implementation-as-usual, PCPs are trained on the World Health Organization Mental Health Gap Action Program Intervention Guide (mhGAP-IG) with trainings conducted by mental health specialists. In RESHAPE, mhGAP-IG training includes the added component of facilitation by people with lived experience of mental illness (PWLE) and their caregivers using PhotoVoice, as well as aspirational figures. The duration of PCP training is the same in both arms. Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework. Reach is operationalized as the accuracy of detection of mental illness in primary care facilities and will be determined by psychiatrists at 3 months after PCPs diagnose the patients. Stigma will be evaluated as a mediator of reach. Cost-effectiveness and other RE-AIM outcomes will be assessed. Twenty-four municipalities, the unit of clustering, will be randomized to either mhGAP-IG implementation-as-usual or RESHAPE arms, with approximately 76 health facilities and 216 PCPs divided equally between arms. An estimated 1100 patients will be enrolled for the evaluation of accurate diagnosis of depression, generalized anxiety disorder, psychosis, or alcohol use disorder. Masking will include PCPs, patients, and psychiatrists. Discussion This study will advance the knowledge of stigma reduction for training PCPs in partnership with PWLE. This collaborative approach to training has the potential to improve diagnostic competencies. If successful, this implementation strategy could be scaled up throughout low-resource settings to reduce the global treatment gap for mental illness. Trial registration ClinicalTrials.gov, NCT04282915 . Date of registration: February 25, 2020.

Abstract Background Adolescents growing up in communities characterised by adversity face multiple risk factors for poor mental health and wellbeing. There is currently a scarcity of research on effective approaches for preventing and treating psychological distress in this population, particularly in humanitarian settings. The powerful impact of the home environment and family support is well known; however, approaches targeting the family are seldom developed or evaluated in such settings. We developed a brief family systemic psychosocial support intervention to be delivered through existing child protection systems with non-specialist facilitators. This paper outlines the study protocol for a randomised controlled trial of the intervention in Lebanon. Methods We will conduct a single-blind hybrid effectiveness-implementation multi-site RCT comparing the locally developed systemic family intervention to a waitlist control group for families residing in vulnerable regions in North Lebanon and Beqaa governorates (including families of Syrian, Palestinian, and Lebanese backgrounds). Outcomes on a range of family, adolescent, and caregiver measures will be assessed at baseline (T0) and post-intervention (T1), and at a 3-month follow-up for the treatment arm (T2). Families will be eligible for the trial if they are identified by implementing organisations as being medium-to-high risk for child protection concerns and have one or more adolescent aged 12–17 who demonstrates significant psychological distress on a self-report brief screening tool. Families will be randomly assigned to a treatment or a waitlist control condition. Families in the waitlist condition will receive a group version of the programme after completion of the study, to allow us to assess feasibility, acceptability, and preliminary indications of intervention effects of this modality. The primary outcome is reduction in overall adolescent-reported psychological distress over time, with post-intervention (T1) as the primary endpoint. Secondary adolescent-reported outcomes include family functioning, psychosocial wellbeing, and emotional regulation difficulties. Secondary caregiver-reported outcomes include parenting style, family functioning, psychological distress, and emotional regulation difficulties. Discussion This trial will provide the first assessment of the effectiveness of the family systemic psychosocial support intervention for use in Lebanon, with important implications for the use of systemic, low-cost, non-specialist interventions for this age range. Trial registration Local registry: National Mental Health Program, Ministry of Public Health, Lebanese Republic. Registered on 19 October 2021 Lebanese Clinical Trial Registry LBCTR2021104870 . Registered on 13 October 2021 Global registry: ISRCTN ISRCTN13751677 . Registered on 1 November 2021

Abstract Aims Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability. Yet there is limited evidence for interventions that prevent adolescent depression and anxiety in low- and middle-income countries (LMICs), where 90% of adolescents live. This article introduces the ‘Improving Adolescent mentaL health by reducing the Impact of poVErty (ALIVE)’ study, its conceptual framework, objectives, methods and expected outcomes. The aim of the ALIVE study is to develop and pilot-test an intervention that combines poverty reduction with strengthening self-regulation to prevent depression and anxiety among adolescents living in urban poverty in Colombia, Nepal and South Africa. Methods This aim will be achieved by addressing four objectives: (1) develop a conceptual framework that identifies the causal mechanisms linking poverty, self-regulation and depression and anxiety; (2) develop a multi-component selective prevention intervention targeting self-regulation and poverty among adolescents at high risk of developing depression or anxiety; (3) adapt and validate instruments to measure incidence of depression and anxiety, mediators and implementation parameters of the prevention intervention; and (4) undertake a four-arm pilot cluster randomised controlled trial to assess the feasibility, acceptability and cost of the selective prevention intervention in the three study sites. Results The contributions of this study include the active engagement and participation of adolescents in the research process; a focus on the causal mechanisms of the intervention; building an evidence base for prevention interventions in LMICs; and the use of an interdisciplinary approach. Conclusions By developing and evaluating an intervention that addresses multidimensional poverty and self-regulation, ALIVE can make contributions to evidence on the integration of mental health into broader development policy and practice.

Abstract Background Most children and adolescents in need of mental healthcare remain untreated even when services are available. This study evaluates the accuracy of a new tool, the Community Case Detection Tool (CCDT). The CCDT uses illustrated vignettes, two questions and a simple decision algorithm to support proactive community-level detection of children, adolescents and families in need of mental healthcare to improve help-seeking. Methods Trusted and respected community members in the Eastern Province of Sri Lanka used the CCDT in their daily routine. Children and families detected as potentially in need of mental healthcare based on utilizing the CCDT (N = 157, aged 6–18 years) were invited for a clinical interview by a mental health counsellor using the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). The CCDT results were compared against the results of the clinical interview. The concurrent validity and performance of the CCDT were also evaluated by comparing the CCDT outcomes against the Strengths and Difficulties Questionnaire (SDQ). Results 7 out of 10 children and families detected by community members using the CCDT were confirmed to be in need for treatment (positive predictive value [PPV] = 0.69; 0.75 when compared to the SDQ). Detections based on the family problem vignette were most accurate (PPV = 0.76), followed by the internalising problem vignette (PPV = 0.71) and the externalising problem vignette (PPV = 0.62). Conclusions The CCDT is a promising low-cost solution to overcome under-detection of children and families in need of mental healthcare. Future research should focus on evaluating the effectiveness, as well as additional strategies to improve help-seeking.

Abstract Background Nearly 60,000 people applied for asylum in the Netherland in 2015, confronting the governmental structures and services with great administrative, logistical and service provision challenges. Refugee children’s psychosocial needs and wellbeing are often overlooked, and post-migration support is of pivotal importance. Methods An easy accessible movement–based psychosocial intervention, called TeamUp, was developed for children aged 6–17 living in refugee reception centres. A mixed-method process evaluation was conducted of (1) implementation process, assessing attendance (n = 2183 children, and n = 209 children); (2) implementation quality, using structured observations at two time points to evaluate facilitator’s (2a) individual-level fidelity (n = 81 facilitators); (2b) team-level fidelity (n = 22 teams); (2c) facilitators’ competencies (n = 81); (2d) trainee perceived self-efficacy pre-post training (n = 73); and (3) perceptions on implementation and outcomes, employing a survey (n = 99), focus group discussions and key informant interviews with children (n = 94), facilitators (n = 24) and reception centre staff (n = 10). Results Attendance lists showed a mean of 8.5 children per session, and children attending 31.3% of sessions. Structured observations demonstrated 49.2% and 58.2% individual-level fidelity, 72.5% and 73.0% team-level fidelity, and 82.9% and 88.4% adequacy in competencies, each at T1 and T2 respectively. The main reported challenges included managing children’s energy regulation (e.g. offering settling moments) and challenging behaviour. Training participation significantly improved perceived self-efficacy for trainees. The facilitator survey demonstrated on average, high satisfaction and self-efficacy, low experienced burden, and high perceived capacity-building support. Qualitatively, TeamUp was positively perceived by all stakeholders and was regarded as contributing to children’s psychosocial outcomes. Conclusion (1) Attendance and group size were lower than expected. (2) The intervention’s facilitator fidelity ranged from moderate to adequate—exhibiting a need for specific fidelity and capacity strengthening—while facilitator competencies were high. Trainee’s perceived self-efficacy improved significantly following a 2-day training. (3) Facilitators expressed high levels of satisfaction, self-efficacy and support, and low burden. The intervention was positively perceived by all stakeholders and to have a positive impact on children’s psychosocial learning and wellbeing.

Abstract Background Evidence-based interventions are needed to reduce depression among adolescents in low- and middle-income countries (LMICs). One approach could be cultural adaptation of psychological therapies developed in high-income countries. We aimed to adapt the World Health Organization’s Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal. Methods We used a participatory, multi-stage adaptation process involving: translation and clinical review of the WHO Manual; desk reviews of adaptations of IPT in LMICs, and literature on child and adolescent mental health interventions and interpersonal problems in Nepal; a qualitative study to understand experiences of adolescent depression and preferences for a community-based psychological intervention including 25 interviews with adolescent boys and girls aged 13–18 with depression, four focus group discussions with adolescents, four with parents/caregivers and two with teachers, six interviews with community health workers and one with a representative from a local non-governmental organisation (total of 126 participants); training of IPT trainers and facilitators and practice IPT groups; and consultation with a youth mental health advisory board. We used the Ecological Validity Framework to guide the adaptation process. Results We made adaptations to optimise treatment delivery and emphasise developmental and cultural aspects of depression. Key adaptations were: integrating therapy into secondary schools for delivery by school nurses and lay community members; adding components to promote parental engagement including a pre-group session with the adolescent and parent to mobilise parental support; using locally acceptable terms for mental illness such as udas-chinta (sadness and worry) and man ko samasya (heart-mind problem); framing the intervention as a training programme to de-stigmatise treatment; and including activities to strengthen relationships between group members. We did not adapt the therapeutic goals of IPT and conserved IPT-specific strategies and techniques, making edits only to the way these were described in the Manual. Conclusions Group IPT can be adapted for adolescents in Nepal and delivered through the education system. A randomised controlled trial is needed to assess the impact and costs of the intervention in this setting. Future research in LMICs to adapt IPT for adolescents could use this adapted intervention as a starting point.

Abstract Background A large mental health treatment gap exists among conflict-affected populations, and Syrian refugees specifically. Promising brief psychological interventions for conflict-affected populations exist such as the World Health Organization’s Problem Management Plus (PM+) and the Early Adolescent Skills for Emotions (EASE) intervention, however, there is limited practical guidance for countries of how these interventions can be taken to scale. The aim of this study was to unpack pathways for scaling up PM+ and EASE for Syrian refugees. Methods We conducted three separate Theory of Change (ToC) workshops in Turkey, the Netherlands, and Lebanon in which PM+ and EASE are implemented for Syrian refugees. ToC is a participatory planning process involving key stakeholders, and aims to understand a process of change by mapping out intermediate and long-term outcomes on a causal pathway. 15–24 stakeholders were invited per country, and they participated in a one-day interactive ToC workshop on scaling up. Results A cross-country ToC map for scale up brief psychological interventions was developed which was based on three country-specific ToC maps. Two distinct causal pathways for scale up were identified (a policy and financing pathway, and a health services pathway) which are interdependent on each other. A list of key assumptions and interventions which may hamper or facilitate the scaling up process were established. Conclusion ToC is a useful tool to help unpack the complexity of scaling up. Our approach highlights that scaling up brief psychological interventions for refugees builds on structural changes and reforms in policy and in health systems. Both horizontal and vertical scale up approaches are required to achieve sustainability. This paper provides the first theory-driven map of causal pathways to help support the scaling-up of evidence-based brief psychological interventions for refugees and populations in global mental health more broadly.

Abstract Background Despite many important developments in the global mental health arena in the past decade, many people with mental health problems still do not have access to good quality mental health care. The aim of this study was to evaluate the perceived impact of a mental health care package (MHCP) in integrating chronic care elements in primary health care for people with mental illness. Methods A controlled pre-post study design was used in 20 primary health care facilities in Chitwan, Nepal. We compared 10 health facilities that had implemented a MHCP (intervention group), with 10 health facilities that had not implemented the MHCP (comparative control group) but provided regular physical health services. We administered the Assessment of Chronic Illness Care (ACIC) tool on a group basis within all 20 health facilities among 37 health workers. Data was collected at three time points; at baseline, midline (at 13 months from baseline) and end line (at 25 months from baseline). Results From baseline to end line, we see a notable shift in the level of support reported by the intervention health facilities compared to those in the comparative control group. While at baseline 10% of the intervention health facilities had basic support for the implementation of chronic illness care, at the end line, 90% of the intervention group reported having reasonable support with the remaining 10% of the intervention facilities reporting that they had full support. In contrast, 20% of the health facilities in the comparative control group at end line still reported having limited support for the implementation of chronic illness care, with the remaining 80% only managing to shift to the next level which is basic support. Conclusions These findings suggest that training and supervision of primary health care workers in the implementation of MHCP interventions can lead to strengthening of the system to better address the needs of patients with chronic mental health problems. However, substantial financial and coordination inputs are needed to implement the MHCP. The comparative control group also demonstrated improvements, possibly due to the administration of the ACIC tool and components of counselling services for family planning and HIV/AIDS services.

Abstract Objective The Community Informant Detection Tool (CIDT) is a paper-based proactive case detection strategy with evidence for improving help-seeking behavior for mental healthcare. Key implementation barriers for the paper-based CIDT include delayed reporting of cases and lack of active follow up. We used mobile phones and structured text messages to improve timeliness of case reporting, encouraging follow up, and case record keeping. 36 female community health volunteers piloted this mobile phone CIDT (mCIDT) for three months in 2017 in rural Nepal. Results Only 8 cases were identified by health volunteers using mCIDT, and only two of these cases engaged with health services post-referral. Accuracy with the mCIDT was considerably lower than paper-based CIDT, especially among older health volunteers, those with lower education, and those having difficulties sending text messages. Qualitative findings revealed implementation challenges including cases not following through on referrals due to perceived lack of staff at health facilities, assumptions among health volunteers that all earthquake-related mental health needs had been met, and lack of financial incentives for use of mCIDT. Based on study findings, we provide 5 recommendations—in particular attitudinal and system preparedness changes—to effectively introduce new mental healthcare technology in low resource health systems.

Abstract Background Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. Methods/design This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20 ± 1 weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. Discussion This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions. Trial registration ClinicalTrials.gov, NCT03747055 .

Abstract Background Despite attempts to improve universal health coverage (UHC) in low income countries like Nepal, most healthcare utilization is still financed by out-of-pocket (OOP) payments, with detrimental effects on the poorest and most in need. Evidence from high income countries shows that depression is associated with increased healthcare utilization, which may lead to increased OOP expenditures, placing greater stress on families. To inform policies for integrating mental healthcare into UHC in LMIC, we must understand healthcare utilization and OOP expenditure patterns in people with depression. We examined associations between symptoms of depression and frequency and type of healthcare utilization and OOP expenditure among adults in Chitwan District, Nepal. Methods We analysed data from a population-based survey of 2040 adults in 2013, who completed the PHQ-9 screening tool for depression and answered questions about healthcare utilization. We examined associations between increasing PHQ-9 score and healthcare utilization frequency and OOP expenditure using negative binomial regression. We also compared utilization of specific outpatient service providers and their related costs among adults with and without probable depression, determined by a PHQ-9 score of 10 or more. Results We classified 80 (3.6%) participants with probable depression, 70.9% of whom used some form of healthcare in the past year compared to 43.9% of people without probable depression. Mean annual OOP healthcare expenditures were $118 USD in people with probable depression, compared to $110 USD in people without. With each unit increase in PHQ-9 score, there was a 14% increase in total healthcare visits (95% CI 7–22%, p

Abstract Background Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- and middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan. Methods We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant’s child. Discussion The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12619001386123 . Registered prospectively on 10/10/2019.

Abstract Background There is evidence that chronic stress negatively impacts parenting among refugees and other war-affected communities. Persistent parental stress and distress may lead to unresponsive, anxious, or overly harsh parenting and a corresponding increase in emotional and behavior problems among children. Most parenting interventions emphasize the acquisition of knowledge and skills; however, this overlooks the deleterious effects of chronic stress on parenting. The Caregiver Support Intervention (CSI) aims to strengthen quality of parenting skills by lowering stress and improving psychosocial wellbeing among refugee caregivers of children aged 3–12 years, while also increasing knowledge and skills related to positive parenting. The CSI is a nine-session psychosocial group intervention delivered by non-specialist providers. It is intended for all adult primary caregivers of children in high-adversity communities, rather than specifically targeting caregivers already showing signs of elevated distress. Methods/design The primary objective of this study is to assess the effectiveness of the CSI through a parallel group randomized controlled study with Syrian refugee families in North Lebanon. Participants will be primary caregivers of children aged 3–12 years, with one index child per family. Families will be randomized to the CSI or a waitlist control group. A total of 240 families (480 caregivers) will be recruited into the study. Randomization will be at the family level, and CSI groups will be held separately for women and men. The study will be implemented in two waves. Outcomes for both arms will be assessed at baseline, post-intervention, and at a 3-month follow-up. The primary outcome is quality of parenting skills. Secondary outcomes include parental warmth and sensitivity, harsh parenting, parenting knowledge, and child psychosocial wellbeing. Putative mediators of the CSI on parenting are caregiver stress, distress, psychosocial wellbeing, and stress management. Discussion This trial may establish the CSI as an effective intervention for strengthening parenting in families living in settings of high adversity, particularly refugee communities. Trial registration International Society for the Registration of Clinical Trials, ISRCTN22321773 . Registered on 5 August 2019

Abstract Background The barriers and facilitating factors for integrating mental health into primary health care have been well documented in the literature, but little is known about the perspectives of primary health care workers (who provide integrated mental health care) on barriers and facilitating factors of the health system for scaling up mental health interventions in low and middle income countries. This study aimed to explore these perspectives of primary health care workers within the health system, and identify possible strategies to optimize the integration of mental health in primary health care. Methods The study was conducted in the Chitwan district of Nepal with 55 purposively selected primary health care workers representing prescribers (N = 35), non-prescribers (N = 12) and Female Community Health Volunteers (N = 8). Using a semi-structured interview guide, experienced qualitative researchers collected data between September 2016 and May 2017. The interviews were audio-taped, transcribed and then translated into English. The transcripts were coded using Nvivo 10 software and themes were generated for the thematic analysis. Results According to the health workers, the facilitating factors for scaling up mental health services in primary health care setting in Nepal included; (1) availability of guidelines, protocols and awareness raising materials, (2) provision of supervision, (3) referral systems being in place, (4) patient record keeping, (5) community sensitizations and home visits, and (6) provision of psychosocial counseling. The barriers identified included; (1) shortage of psychotropic medicines, (2) lack of private space for counseling, (3) workload and health workers’ grievances regarding incentives, and (4) perceived stigma causing dropouts. Conclusions The findings suggest that implementation of mental health services through primary health care workers in resource-poor setting is possible when health system level barriers are addressed and facilitating factors are strengthened. In order to address these barriers the health workers suggested a few strategies which included; ensuring dedicated staff available at health facility, allocating dedicated and confidential space for counseling, improving on incentives and motivational benefits to existing health staff, organizing policy level advocacy for mental health, improving medicine supply chain management and strengthening systems for supervision, referral and mental health information management.

Background Common mental disorders are frequently experienced by refugees. This study evaluates the impact of a brief, lay provider delivered group-based psychological intervention [Group Problem Management Plus (gPM+)] on the mental health of refugees in a camp, as well as on parenting behavior and children’s mental health. Methods and findings In this single-blind, parallel, randomized controlled trial, 410 adult Syrian refugees (300 females, 110 males) in Azraq Refugee Camp (Jordan) were identified through screening of psychological distress (≥16 on the Kessler Psychological Distress Scale) and impaired functioning (≥17 on the WHO Disability Assessment Schedule). Participants were randomly allocated to gPM+ or enhanced usual care (EUC) involving referral information for psychosocial services on a 1:1 ratio. Participants were aware of treatment allocation, but assessors were blinded to treatment condition. Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL; depression and anxiety scales) assessed at baseline, 6 weeks, and 3 months follow-up as the primary outcome time point. It was hypothesized that gPM+ would result in greater reductions of scores on the HSCL than EUC. Secondary outcomes were disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behavior, and children’s mental health. Between October 15, 2019 and March 2, 2020, 624 refugees were screened for eligibility, 462 (74.0%) screened positive, of whom 204 were assigned to gPM+ and 206 to EUC. There were 168 (82.4%) participants in gPM+ and 189 (91.7%) in EUC assessed at follow-up. Intent-to-treat analyses indicated that at follow-up, participants in gPM+ showed greater reduction on HSCL depression scale than those receiving EUC (mean difference, 3.69 [95% CI 1.90 to 5.48], p = .001; effect size, 0.40). There was no difference between conditions in anxiety (mean difference −0.56, 95% CI −2.09 to 0.96; p = .47; effect size, −0.03). Relative to EUC, participants in gPM+ had greater reductions in severity of personally identified problems (mean difference 0.88, 95% CI 0.07 to 1.69; p = .03), and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < .001). There were no significant differences between conditions for changes in PTSD, disability, grief, prodromal symptoms, or childhood mental health outcomes. Mediation analysis indicated the change in inconsistent disciplinary parenting was associated with reduced attentional (β = 0.11, SE .07; 95% CI .003 to .274) and internalizing (β = 0.08, SE .05; 95% CI .003 to 0.19) problems in children. No adverse events were attributable to the interventions or the trial. Major limitations included only one-quarter of participants being male, and measures of personally identified problems, grief, prodromal psychotic symptoms, inconsistent parenting behavior, and children’s mental health have not been validated with Syrians. Conclusions In camp-based Syrian refugees, a brief group behavioral intervention led to reduced depressive symptoms, personally identified problems, and disciplinary parenting compared to usual care, and this may have indirect benefits for refugees’ children. The limited capacity of the intervention to reduce PTSD, disability, or children’s psychological problems points to the need for development of more effective treatments for refugees in camp settings. Trial registration Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619001386123. Richard A. Bryant and colleagues evaluate effects of a lay provider-delivered intervention on adult Syrian refugees’ mental health, parenting behavior, and their children’s mental health. Author summary Why was this study done? There are approximately 80 million refugees and forcibly displaced people today, and they are at greater risk for common mental disorders. Most countries hosting refugees lack the health resources to address these mental health problems. In response to this situation, the World Health Organization has developed a brief psychological intervention that can be delivered by trained lay workers that aims to reduce psychological distress following adversity. To our knowledge, this study was the first to test the effectiveness of the Group Problem Management Plus (gPM+) program in distressed refugees in a refugee camp. What did the researchers do and find? This study screened adult Syrian refugees in a camp in in Jordan, and subsequently randomized 410 adult refugees who displayed distress and impaired functioning to either 5 individual sessions of gPM+ or enhanced usual care (EUC). Independent assessments indicated that 3 months following treatment, refugees who received gPM+ reported significantly less depression but not anxiety, with a moderate effect relative to EUC. gPM+ also led to greater reductions inconsistent disciplinary parenting, and this was associated with greater reductions in attentional and internalizing problems in refugees’ children. What do these findings mean? This study suggests that mental health nonspecialists can be briefly trained in gPM+, and they can deliver this intervention in a way that it can improve mental health of refugees. This brief intervention has the potential to scale up mental health services for refugees in settings that lack adequate health resources, and this may have downstream benefits for refugees’ children.

Abstract Background Despite the availability of evidence-based treatment, there is a substantial gap between the number of individuals in need of mental health care and those who receive treatment. The aim of this study was to assess changes in treatment coverage and barriers to mental health care among adults with depression and alcohol use disorder (AUD) before and after implementation of a district mental health care plan (MHCP) in Nepal. Methods The repeat population-based cross-sectional community survey was conducted with randomly selected adults in the baseline (N = 1983) and the follow-up (N = 1499) surveys, 3 years and 6 months apart. The Patient Health Questionnaire and Alcohol Use Disorder Identification Test were used to screen people with probable depression and AUD. Barriers to seeking mental health care were assessed by using a standardized tool, the Barriers to Care Evaluation Scale (BACE). Results The proportion of the participants receiving treatment for depression increased by 3.7 points (from 8.1% in the baseline to 11.8% in the follow-up) and for AUD by 5.2 points (from 5.1% in the baseline to 10.3% in the follow-up study), however, these changes were not statistically significant. There was no significant reduction in the overall BACE score in both unadjusted and adjusted models for both depression and AUD. The possible reasons for non-significant changes in treatment coverage and barriers to care could be that (i) the method of repeat population level surveys with a random sample was too distal to the intervention to be able to register a change and (ii) the study was underpowered to detect such changes. Conclusion The study found non-significant trends for improvements in treatment coverage and barriers to mental health care following implementation of the district mental health care plan. The key areas for improvement in the current strategy to improve treatment coverage and barriers to mental health care included change in the content of the existing community sensitization program, particularly for changing attitude and intention of people with mental illness for seeking care.

Abstract Background There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed the Early Adolescent Skills for Emotions (EASE) psychological intervention for young adolescents with internalising problems. EASE is group-based (seven sessions for adolescents, three sessions for their caregivers) and can be delivered by non-specialist providers. This paper outlines the study protocols for two trials of EASE in the Middle East - one in Lebanon and one in Jordan. Methods We will conduct two, single-blind, two-arm, individually randomised group treatment trials in Lebanon and Jordan, with at least 445 young adolescents per trial. Adolescents will be screened eligible for the trial if they demonstrate levels of psychological distress indicative of internalizing problems requiring treatment. Participants will be randomly assigned to receive the EASE intervention, or enhanced usual care (one home-visit psychoeducation session). The primary outcome is reduction in overall child-reported psychological distress over time, with 3 months post-treatment as the primary end point. Secondary child-reported outcomes include post-traumatic stress symptoms, depression symptoms, daily functioning, and wellbeing. Secondary caregiver-reported outcomes include parenting style, overall child distress, and caregiver psychological distress. Coping strategy use will be explored as a mediator of treatment effects in Lebanon, and relevant moderators of treatment effects will be explored. Discussion These trials will provide the first assessments of the effectiveness of the EASE intervention for use in the Middle East, with important implications for the use of low-intensity, non-specialist interventions for this age range. Trial registration Lebanon: ISRCTN75375136. Registered on 11 March 2019. Jordan: Australia New Zealand Clinical Trials Registry, ACTRN12619000341123. Registered on 5 March 2019 (https://www.anzctr.org.au/)

Abstract Background Because of the high burden of untreated mental illness in humanitarian settings and low- and middle-income countries, scaling-up effective psychological interventions require a cultural adaptation process that is feasible and acceptable. Our adaptation process incorporates changes into both content and implementation strategies, with a focus on local understandings of distress and treatment mechanisms of action. Methods Building upon the ecological validity model, we developed a 10-step process, the mental health Cultural Adaptation and Contextualization for Implementation (mhCACI) procedure, and piloted this approach in Nepal for Group Problem Management Plus (PM+), a task-sharing intervention, proven effective for adults with psychological distress in low-resource settings. Detailed documentation tools were used to ensure rigor and transparency during the adaptation process. Findings The mhCACI is a 10-step process: (1) identify mechanisms of action, (2) conduct a literature desk review for the culture and context, (3) conduct a training-of-trainers, (4) translate intervention materials, (5) conduct an expert read-through of the materials, (6) qualitative assessment of intervention population and site, (7) conduct practice rounds, (8) conduct an adaptation workshop with experts and implementers, (9) pilot test the training, supervision, and implementation, and (10) review through process evaluation. For Group PM+, key adaptations were harmonizing the mechanisms of action with cultural models of ‘tension’; modification of recruitment procedures to assure fit; and development of a skills checklist. Conclusion A 10-step mhCACI process could feasibly be implemented in a humanitarian setting to rapidly prepare a psychological intervention for widespread implementation.

Background: Approximately 10% of Syrian refugees currently reside in camp settings, which can impose additional post-migration stressors. With elevated rates of psychological distress and few available resources, task-shifting psychosocial programmes are necessary to provide adequate care. One such programme developed by the World Health Organization (WHO) is Group Problem Management Plus (GroupPM+). Objective: This study aimed to test the safety and acceptability of GroupPM+ in a refugee camp and to identify areas for adaptation in preparation for a definitive RCT. Method: A feasibility randomized controlled trial (RCT) was conducted in Azraq refugee camp in Jordan. Inclusion criteria were: (1) Syrian adults aged ≥18 years, (2) parent of a child aged 10–16 years, (3) experiencing psychological distress as defined by a score of ≥16 on the Kessler Distress Scale, and (4) ≥17 on the WHO Disability Assessment Schedule 2.0. Following baseline assessments, participants were randomized to receive GroupPM+ or enhanced treatment-as-usual. Post-assessments were conducted one week following the last GroupPM+ session. Primary outcomes were feasibility and acceptance of GroupPM+; symptoms of anxiety, depression, PTSD, prodromal psychosis, grief, and child’s self-reported psychological distress were also assessed. Results: Of the 207 persons screened, 64 (31%) screened positive for psychological distress. Of the 35 randomized into the GroupPM+ intervention, 24 (69%) completed the intervention. No adverse events were reported throughout the trial. Children whose parents received GroupPM+ had greater reductions in internalizing and externalizing symptoms at posttreatment. 55 (86%) participants completed the post-assessment follow-up. These results demonstrate both the feasibility of conducting the trial in a camp and acceptance of the GroupPM+ intervention by Syrian refugees. Conclusions: Following the feasibility trial, both the implementation procedures and intervention were safe and culturally acceptable. The results support the readiness for a definitive RCT to determine the effectiveness and cost-effectiveness of the intervention in camp settings.

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.

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.

Evaluations of education technology (ed tech) interventions in humanitarian settings are scarce. We present a proof-of-concept study of Can't Wait to Learn, a digital game-based learning program that combines an experiential, active learning design with meaningful, competency-appropriate, and contextually relevant content. We assessed the feasibility of using this program to address the current education gap in Lebanon by implementing its mathematics component in basic literacy and numeracy classes (n=30) with out-of-school children (n=390) ages 10-14. We estimated changes in numeracy competency and psychosocial wellbeing and conducted focus group discussions (n=16) and key informant interviews (n=19) with children, facilitators, parents, and partner staff members to understand the lived experience, perceived impact, and implementation challenges of the program. Our findings support the feasibility of using ed tech programs to meet the needs of out-of-school children, as we saw significant improvements in numeracy, psychological symptoms, and self-esteem; positive reported experiences with the program; increased motivation among the children; and overall ease of implementation. Our suggested improvements to the game design and implementation model will support ongoing program adaptation and implementation, with the goal of increasing access to quality education for children living in humanitarian settings. Our findings will inform future studies that seek to conclusively determine the program's effectiveness.

Abstract Background Obtaining accurate and valid measurements of disruptive behavior disorders remains a challenge in non-Western settings due to variability in societal norms for child behavior and a lack of tools developed outside of Western contexts. This paper assesses the reliability and construct validity of the Disruptive Behavior International Scale – Nepal version (DBIS-N)—a scale developed using ethnographic research in Nepal—and compares it with a widely used Western-derived scale in assessing locally defined child behavior problems. Methods We assessed a population-based sample of 268 children ages 5–15 years old in Nepal for behavior problems with a pool of candidate items developed from ethnographic research. We selected final items for the DBIS-N using exploratory factor analysis in a randomly selected half of the sample and then evaluated the model fit using confirmatory factor analysis in the remaining half. We compared the classification accuracy and incremental validity of the DBIS-N and Eyberg Child Behavior Inventory (ECBI) using local defined behavior problems as criteria. Local criteria were assessed via parent report using: 1) local behavior problem terms, and 2) a locally developed vignette-based assessment. Results Ten items were selected for the final scale. The DBIS-N had good internal consistency (Cronbach’s α: 0.84) and excellent test-retest reliability (intraclass correlation 0.93, r = .93). Classification accuracy and area under the curve (AUC) were similar and high for both the ECBI (AUC: 0.83 and 0.85) and DBIS-N (AUC: 0.83 and 0.85) on both local criteria. The DBIS-N added predictive value above the ECBI in logistic regression models, supporting its incremental validity. Conclusions While both the DBIS-N and the ECBI had high classification accuracy for local idioms for behavior problems, the DBIS-N had a more coherent factor structure and added predictive value above the ECBI. Items from the DBIS-N were more consistent with cultural themes identified in qualitative research, whereas multiple items in the ECBI that did not fit with these themes performed poorly in factor analysis. In conjunction with practical considerations such as price and scale length, our results lend support for the utility of the DBIS-N for the assessment of locally prioritized behavior problems in Nepal.

Abstract Background The prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6–8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial. Methods This protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n = 60) or enhanced usual care (EUC; n = 60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7–10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT. Discussion Outcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal. Trial registration ClinicalTrials.gov identifier: NCT03359486

Abstract Background This study evaluates the feasibility, acceptability, and outcomes of a combined school- and family-based intervention, delivered by psychosocial counselors, for children with behavior problems in rural Nepal. Methods Forty-one children participated at baseline. Two students moved to another district, meaning 39 children, ages 6–15, participated at both baseline and follow-up. Pre-post evaluation was used to assess behavioral changes over a 4-month follow-up period (n = 39). The primary outcome measure was the Disruptive Behavior International Scale—Nepal version (DBIS-N). The secondary outcome scales included the Child Functional Impairment Scale and the Eyberg Child Behavior Inventory (ECBI). Twelve key informant interviews were conducted with community stakeholders, including teachers, parents, and community members, to assess stakeholders’ perceptions of the intervention. Results The study found that children’s behavior problems as assessed on the DBIS-N were significantly lower at follow-up (M = 13.0, SD = 6.4) than at baseline (M = 20.5, SD = 3.8), p

Abstract Background Although depression and alcohol use disorder (AUD) are expected to be common among patients presenting to primary health care setting, there is limited research on prevalence of depression and AUD among people attending primary health care services in low-income countries. The aim of this study was to assess the prevalence of depression and AUD among adults attending primary care facilities in Nepal and explore factors associated with depression and AUD. Methods We conducted a population-based cross-sectional health facility survey with 1474 adults attending 10 primary healthcare facilities in Chitwan district, Nepal. The prevalence of depression and AUD was assessed with validated Nepali versions of the Patient Health Questionnaire (PHQ-9) and Alcohol Use Disorder Identification Test (AUDIT). Results 16.8% of the study sample (females 19.6% and males 11.3%) met the threshold for depression and 7.3% (males 19.8% and females 1.1%) for AUD. The rates of depression was higher among females (RR = 1.48, P = 0.009), whereas rates of AUD was lower among females (RR = 0.49, P = 0.000). Rates of depression and AUD varied based on education, caste/ethnicity, occupations and family income. Conclusions In Nepal, one out of five women attending primary care services have depression and one out of five men have AUD. Primary care settings, therefore, are an important setting for detection and treatment initiation for these conditions. Given that “other” occupation is at increased risk for both conditions, it will be important to assure that treatments are feasible and effective for this high risk group.

Abstract Background Psychotropic drugs play an important role in the treatment of mental, neurological and substance use disorders. Despite the advancement of the use of psycho-pharmaceuticals in the developed countries, the psychotropic drug production and supply chain management in low- and middle- income countries are still poorly developed. This study aims to explore the perceptions of stakeholders involved in all stages of the psychotropic drug supply chain about the need, quality, availability and effectiveness of psychotropic drugs, as well as barriers to their supply chain management. The study was conducted among 65 respondents from the Kathmandu, Chitwan and Pyuthan districts, grouped into four categories: producers, promoters and distributors (N = 22), policy makers and government actors (N = 8), service providers (N = 21) and service users/family members (N = 14). Results The respondents reported that psychotropic drugs, despite having side effects, are 1) needed, 2) available in major regional centers and 3) are effective for treating mental health problems. The stigma associated with mental illness, however, forces patients and family members to hide their use of psychotropic drugs. The study found that the process of psychotropic drug supply chain management is similar to other general drugs, with the exceptions of strict pre-approval process, quantity restriction (for production and import), and mandatory record keeping. Despite these regulatory provisions, respondents believed that the misuse of psychotropic drugs is widespread and companies are providing incentives to prescribers and retailers to retain their brand in the market. Conclusions The production and supply chain management of psychotropic drugs is influenced by the vested interests of pharmaceutical companies, prescribers and pharmacists. In the context of the government of Nepal’s policy of integrating mental health into primary health care and increased consumption of psychotropic drugs in Nepal, there is a need for massive education and awareness as well as strict monitoring and supervision to avoid the misuse of psychotropic drugs.

Abstract Background Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, REducing Stigma among HealthcAre Providers to ImprovE mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. Methods This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities (n = 150); indirect beneficiaries are their patients (n = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mhGAP), clinical competency (ENhancing Assessment of Common Therapeutic factors, ENACT), and implicit attitudes (Implicit Association Test, IAT), and patient outcomes including stigma-related barriers to care, daily functioning, and symptoms. Discussion The pilot and feasibility study will contribute to refining recommendations for implementation of mhGAP and other mental health services in primary healthcare settings in low-resource health systems. The pilot c-RCT findings will inform an effectiveness trial of RESHAPE to advance the evidence-base for optimal approaches to training and supervision for non-specialist providers. Trial registration ClinicalTrials.gov identifier, NCT02793271

Following publication of the original article [1], we have been notified that Figure 1 was published with the track changes. In this Correction the incorrect and correct Fig. 1 are shown.

Abstract Background Despite increasing efforts to expand availability of mental health services throughout the world, there continues to be limited utilization of these services by persons with mental illness and their families. Community-based detection that facilitates identification and referral of people with mental health problems has been advocated as an effective strategy to increase help-seeking and service utilization. The Community Informant Detection Tool (CIDT) was developed for the community informants to identify people with depression, psychosis, alcohol use problems, epilepsy, and child behavioral problems in community settings. The CIDT has been validated in Nepal and found to be effective in promoting treatment initiation. To facilitate replication in other settings, this paper describes the development process of CIDT and the steps to achieve comprehensibility, utility and feasibility. Methods The CIDT was developed in four steps. First, case vignettes and illustrations were created incorporating local idioms of distress for symptoms of each disorder with an expert panel of 25 Nepali mental health professionals. Second, the utility of a draft tool was assessed through focus group discussions (n = 19) and in-depth interviews (n = 6). Third, a practice run was conducted assessing applicability of the tool through IDI among purposively selected community informants (n = 8). Finally, surveys were administered to 105 community informants to assess feasibility. Results The first through third steps led to modifications in the format and presentation of the CIDT. The pilot test found CIDT to be comprehensible and feasible for detection and referral of all conditions except child behavioral problems. Female community health volunteers were recommended as the most appropriate persons to utilize the CIDT. Conclusion Community-based detection using the CIDT for persons in need of mental health care is perceived to be useful and feasible by key community stakeholders who would integrate the tool into their daily activities.

Abstract Delivery of effective mental health and psychosocial support programs requires knowledge of existing health systems and socio-cultural context. To respond rapidly to humanitarian emergencies, international organizations often seek to design programs according to international guidelines and mobilize external human resources to manage and deliver programs. Familiarizing international humanitarian practitioners with local culture and contextualizing programs is essential to minimize risk of harm, maximize benefit, and optimize efficient use of resources. Timely literature reviews on traditional health practices, cultural beliefs and attitudes toward mental health and illness, local health care systems and previous experiences with humanitarian interventions can provide international practitioners with crucial background information to improve their capacity to work efficiently and with maximum benefit. In this paper, we draw on experience implementing desk review guidance from the World Health Organization (WHO) and UNHCR, the United Nations Refugee Agency (2012) in four diverse humanitarian crises (earthquakes in Haiti and Nepal; forced displacement among Syrians and Congolese). We discuss critical parameters for the design and implementation of desk reviews, and discuss current challenges and future directions to improve mental health care and psychosocial support in humanitarian emergencies.

Abstract Background Assessing and understanding health systems governance is crucial to ensure accountability and transparency, and to improve the performance of mental health systems. There is a lack of systematic procedures to assess governance in mental health systems at a country level. The aim of this study was to appraise mental health systems governance in Nepal, with the view to making recommendations for improvements. Methods In-depth individual interviews were conducted with national-level policymakers (n = 17) and district-level planners (n = 11). The interview checklist was developed using an existing health systems governance framework developed by Siddiqi and colleagues as a guide. Data analysis was done with NVivo 10, using the procedure of framework analysis. Results The mental health systems governance assessment reveals a few enabling factors and many barriers. Factors enabling good governance include availability of mental health policy, inclusion of mental health in other general health policies and plans, increasing presence of Non-Governmental Organizations (NGOs) and service user organizations in policy forums, and implementation of a few mental health projects through government-NGO collaborations. Legal and policy barriers include the failure to officially revise or fully implement the mental health policy of 1996, the existence of legislation and several laws that have discriminatory provisions for people with mental illness, and lack of a mental health act and associated regulations to protect against this. Other barriers include lack of a mental health unit within the Ministry of Health, absence of district-level mental health planning, inadequate mental health record-keeping systems, inequitable allocation of funding for mental health, very few health workers trained in mental health, and the lack of availability of psychotropic drugs at the primary health care level. Conclusions In the last few years, some positive developments have emerged in terms of policy recognition for mental health, as well as the increased presence of NGOs, increased presence of service users or caregivers in mental health governance, albeit restricted to only some of its domains. However, the improvements at the policy level have not been translated into implementation due to lack of strong leadership and governance mechanisms.

Abstract Background Service user and caregiver involvement has become an increasingly common strategy to enhance mental health outcomes, and has been incorporated in the mental healthpolicies of many developed nations. However, this practice is non-existent or fragmented in low and middle income countries (LMICs). Instances of service user and caregiver involvement have been rising slowly in a few LMICs, but are rarely described in the literature. Very little is known about the context of user and caregiver participation in mental health system strengthening processes in a low-income, disaster- and conflict-affected state such as Nepal. Methods This study explores (a) the extent and experiences of service user and caregiver involvement in policy making, service planning, monitoring, and research in Nepal; (b) perceived barriers to such involvement; and (c) possible strategies to overcome barriers. Key Informant Interviews (n = 24) were conducted with service users and caregivers who were either affiliated to a mental health organization or receiving menta health care integrated within primary care. Purposive sampling was employed. Data collection was carried out in 2014 in Chitwan and Kathmandu districts of Nepal. Data analysis was carried out in NVivo10 using a framework approach. Results The involvement of service users affiliated to mental health organizations in policy development was reported to be ‘tokenistic’. Involvement of caregivers was non-existent. Perceived barriers to greater involvement included lack of awareness, stigma and discrimination, poor economic conditions, the centralized health system, and lack of strong leadership and unity among user organizations. Increased focus on reducing public as well as self-stigma, improved policy frameworks and initiatives, and decentralization of care are some strategies that may facilitate service user and caregiver involvement. Conclusion The study highlighted need for user and caregiver networks free from competing interests and priorities. Improved policy frameworks and decentralization of care may support meaningful service user and caregiver involvement.

BackgroundCurrent coverage of mental healthcare in low- and middle-income countries is very limited, not only in terms of access to services but also in terms of financial protection of individuals in need of care and treatment.AimsTo identify the challenges, opportunities and strategies for more equitable and sustainable mental health financing in six sub-Saharan African and South Asian countries, namely Ethiopia, India, Nepal, Nigeria, South Africa and Uganda.MethodIn the context of a mental health systems research project (Emerald), a multi-methods approach was implemented consisting of three steps: a quantitative and narrative assessment of each country's disease burden profile, health system and macro-fiscal situation; in-depth interviews with expert stakeholders; and a policy analysis of sustainable financing options.ResultsKey challenges identified for sustainable mental health financing include the low level of funding accorded to mental health services, widespread inequalities in access and poverty, although opportunities exist in the form of new political interest in mental health and ongoing reforms to national insurance schemes. Inclusion of mental health within planned or nascent national health insurance schemes was identified as a key strategy for moving towards more equitable and sustainable mental health financing in all six countries.ConclusionsIncluding mental health in ongoing national health insurance reforms represent the most important strategic opportunity in the six participating countries to secure enhanced service provision and financial protection for individuals and households affected by mental disorders and psychosocial disabilities.Declaration of interestD.C. is a staff member of the World Health Organization.

BackgroundLittle is known about the household economic costs associated with mental, neurological and substance use (MNS) disorders in low- and middle-income countries.AimsTo assess the association between MNS disorders and household education, consumption, production, assets and financial coping strategies in Ethiopia, India, Nepal, Nigeria, South Africa and Uganda.MethodWe conducted an exploratory cross-sectional household survey in one district in each country, comparing the economic circumstances of households with an MNS disorder (alcohol-use disorder, depression, epilepsy or psychosis) (n = 2339) and control households (n = 1982).ResultsDespite some heterogeneity between MNS disorder groups and countries, households with a member with an MNS disorder had generally lower levels of adult education; lower housing standards, total household income, effective income and non-health consumption; less asset-based wealth; higher healthcare expenditure; and greater use of deleterious financial coping strategies.ConclusionsHouseholds living with a member who has an MNS disorder constitute an economically vulnerable group who are susceptible to chronic poverty and intergenerational poverty transmission.Declaration of interestD.C. is a staff member of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the World Health Organization.

In humanitarian settings, mental health and psychosocial support services (MHPSS) are often delivered in group-based formats. Group interventions enable providers to reach more individuals when resources and technical expertise are limited. Group-based programs also foster social support, empathy, and collective problem-solving among the participants. To remedy the current lack of tools available to assess the group facilitation competencies of individuals delivering group-based MHPSS, we made it our objective to develop such a tool. Our approach, which focused on adults, complimented a similar initiative underway for children and adolescents. We reviewed MHPSS manuals to identify key group facilitation competencies, which include developing and reviewing group ground rules, facilitating participation among all group members, fostering empathy between members, encouraging collaborative problem-solving, addressing barriers to attendance, time management, and ensuring group confidentiality. We then developed the Group Facilitation Assessment of Competencies (GroupACT) Tool. The GroupACT is a structured observational tool for assessing these competencies during standardized role-plays with actor clients, or in vivo during the delivery of group sessions with actual clients. We conclude this article with guidance for using the GroupACT to assess facilitators' competencies in providing group-based MHPSS in the health, education, protection, and other sectors in humanitarian settings.

Abstract Background Research on information systems for mental health in low and middle income countries (LMICs) is scarce. As a result, there is a lack of reliable information on mental health service needs, treatment coverage and the quality of services provided. Methods With the aim of informing the development and implementation of a mental health information sub-system that includes reliable and measurable indicators on mental health within the Health Management Information Systems (HMIS), a cross-country situation analysis of HMIS was conducted in six LMICs (Ethiopia, India, Nepal, Nigeria, South Africa and Uganda), participating in the ‘Emerging mental health systems in low and middle income countries’ (Emerald) research programme. A situation analysis tool was developed to obtain and chart information from documents in the public domain. In circumstances when information was inadequate, key government officials were contacted to verify the data collected. In this paper we compare the baseline policy context, human resources situation as well as the processes and mechanisms of collecting, verifying, reporting and disseminating mental health related HMIS data. Results The findings suggest that countries face substantial policy, human resource and health governance challenges for mental health HMIS, many of which are common across sites. In particular, the specific policies and plans for the governance and implementation of mental health data collection, reporting and dissemination are absent. Across sites there is inadequate infrastructure, few HMIS experts, and inadequate technical support and supervision to junior staff, particularly in the area of mental health. Nonetheless there are also strengths in existing HMIS where a few mental health morbidity, mortality, and system level indicators are collected and reported. Conclusions Our study indicates the need for greater technical and resources input to strengthen routine HMIS and develop standardized HMIS indicators for mental health, focusing in particular on indicators of coverage and quality to facilitate the implementation of the WHO mental health action plan 2013–2020.