Mark van Ommeren

Introduction Evidence-based and scalable prevention and promotion focused mental health and psychosocial support interventions are needed for conflict-affected populations in humanitarian settings. This study retrospectively assessed whether participation in Self Help Plus (SH+) versus enhanced usual care (EUC) resulted in reduced incidence of probable mental disorder and increased positive mental health and well-being post-intervention among South Sudanese refugee women in Uganda. Methods This study used secondary data from treatment-oriented pilot (n=50) and fully-powered cluster randomised controlled trials (cRCT)s (n=694) of SH+ versus EUC. Data from baseline and post-intervention assessments were combined. A composite latent indicator for mental health problems was generated using mental health and well-being measures included in both cRCTs. In order to assess incidence, a binary variable approximating probable mental disorder was created to exclude those with probable mental disorder from the analysis sample and as the primary prevention outcome. The promotive effects of SH+ relative to EUC were examined in the same sample by assessing subjective well-being and psychological flexibility scale scores. Results A single factor for mental health problems was identified with all factor loadings >0.30 and acceptable internal consistency (α=0.70). We excluded 161 women who met criteria for probable mental disorder at baseline. Among those with at least moderate psychological distress but without probable mental disorder at baseline and with follow-up data (n=538), the incidence of probable mental disorder at post-intervention was lower among those who participated in SH+ relative to EUC (Risk ratio =0.16, 95% CI: 0.05 to 0.53). Participation in SH+ versus EUC was also associated with increased subjective well-being (β=2.62, 95% CI: 1.63 to 3.60) and psychological flexibility (β=4.55, 95% CI: 2.92 to 6.18) at post-intervention assessment. Conclusions These results support the use and further testing of SH+ as a selective and indicated prevention and promotion focused psychosocial intervention in humanitarian settings. Trial registration number ISRCTN50148022.

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. 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. 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. 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/ )

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.

Background: The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, psychological intervention program delivered by trained non-specialist that addresses common mental disorders. The objectives of this study are to evaluate effectiveness and cost-effectiveness of PM+ in a specialized mental health care facility in Pakistan. Methods: A single blind individual randomized controlled trial (RCT) will be carried out in the outpatient department of a specialized mental healthcare facility in Rawalpindi, Pakistan. After informed consent, patients with high psychological distress (General Health Questionnaire-12 (score >2) and functional impairment (WHO Disability Assessment Schedule 2.0 score >16) will be randomised to PM+ plus treatment as usual (n = 96) or TAU only (n = 96). The primary outcome is the psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale and improvement in functioning as measured by WHODAS at 20 weeks after baseline. Secondary outcomes include improvement in symptoms of depression, post-traumatic stress disorder, levels of social support and cost effectiveness evaluation. Qualitative interviews will be conducted to evaluate the process of implementing PM+ including barriers and facilitators in implementation and possibility of integration of PM+ program in specialized mental health care facilities in Pakistan. Discussion: The results of this study will be helpful in evaluating the effectiveness of the approach of training non specialists, based in the specialized mental health care facilities in delivering evidence based psychological interventions in the low resource settings. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000381482. Registered Retrospectively on March 23, 2016

The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention. The aim of this trial is to evaluate the locally adapted PM+ Group intervention for women in Swat, Pakistan. This PM+ Group trial is a two-arm, single-blind, cluster randomised controlled trial conducted in a community-based setting with women in rural Pakistan. PM+ is delivered in partnership with the Lady Health Worker (LHW) Programme which provides community-based health care to women in Pakistan. Thirty-four LHW clusters will be randomised in a 1:1 allocation ratio using a permuted-block randomisation method. Participants screened and found to meet the inclusion criteria will be allocated to either the PM+ intervention group (n = 306), or the control arm (n = 306). The manualised PM+ intervention involves five sessions, each lasting 3 h, and introduces four strategies applied by participants to problems that they are facing. It is delivered by local female facilitators with a minimum of 16 years of education who are provided with targeted training and supervision. The primary outcome is individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 20 weeks after baseline. Secondary outcomes include major depression, post-traumatic stress disorder, levels of social support, levels of functioning, and economic effectiveness. Intervention acceptability will be explored through an embedded qualitative study. The PM+ Group trial will provide important evidence on the effectiveness of an empirically supported psychological treatment delivered by nonspecialists in a humanitarian setting. If proven effective, the qualitative component will inform strategies for PM+ Group scale-up in health systems in other humanitarian settings. Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000037404. Registered on 19 January 2016; WHO Protocol ID RPC705, v.4, 2 November 2015.