DOI: 10.7924/r4gh9jq3g
title: Data from: Effectiveness of Group Problem Management Plus a brief psychological intervention for adults affected by humanitarian disasters in Nepal: a cluster randomized controlled trial

description: Background: Globally, 168 million people are impacted by humanitarian emergencies worldwide, presenting increased risk of experiencing a mental disorder. Our objective was to test effectiveness of a brief group psychological treatment delivered by trained facilitators without prior professional mental health training in a disaster-prone setting. 

Methods and findings: We conducted a cluster randomized controlled trial from November 25, 2018 through September 30, 2019. Participants in both arms were assessed at baseline, midline (7-weeks post-baseline; after treatment in the experimental arm) and endline (20-weeks post-baseline, approximately 3 months post-treatment). The intervention was Group Problem Management Plus (Group PM+) a psychological treatment of 5 weekly sessions, which was compared with enhanced usual care consisting of a family psychoeducation meeting with a referral option to primary care providers trained in mental healthcare. The setting was 72 wards (geographic unit of clustering) in eastern Nepal, with one PM+ group per ward in the treatment arm. Wards were eligible if they were in disaster-prone regions and residents spoke Nepali. Wards were assigned to study arms based on covariate constrained randomization. Eligible participants were adult women and men 18 years of age and older who met screening criteria for psychological distress and functional impairment. Outcomes were measured at the participant level, with assessors blinded to group assignment. The primary outcome was psychological distress assessed with the General Health Questionnaire (GHQ-12). Secondary outcomes included depression symptoms, posttraumatic stress disorder (PTSD) symptoms, "heart-mind" problems, social support, somatic symptoms and functional impairment. The hypothesized mediator was skill use aligned with the treatment's mechanisms of action. 324 participants were enrolled in the control arm (36 wards) and 319 in the Group PM+ arm (36 wards). Endline assessments were completed by 302 participants in the control arm (36 wards) and 303 participants in the Group PM+ arm (36 wards). At the midline assessment (immediately after Group PM+ in the experimental arm), mean GHQ-12 total score was 2.7 units lower in Group PM+ compared to control (95% CI: 1.7, 3.7, p<0.001); standardized mean difference of -0.4 (95% CI: -0.5, -0.2). At 3 months post-treatment (primary endpoint), mean GHQ-12 total score was 1.4 units lower in Group PM+ compared to control (95% CI: 0.3, 2.5, p=0.014); standardized mean difference of -0.2 (95% CI: -0.4, 0.0). Group PM+ was associated at endline with a larger proportion attaining more than 50% reduction in depression symptoms (29.9% of Group PM+ arm vs.17.3% of control arm, risk ratio=1.7, 95% CI: 1.2, 2.4, p=0.002). Fewer participants in the Group PM+ arm continued to have "heart-mind" problems at endline (58.8%) compared to the control arm (69.4%), risk ratio=0.8 (95% CI: 0.7, 1.0, p=0.042). Group PM+ was not associated with lower PTSD symptoms or functional impairment. Use of psychosocial skills at midline explained 31% of the PM+ effect on endline GHQ-12 scores. Adverse events in the control arm included one suicide death and one reportable incidence of domestic violence; in the Group PM+ arm there was one death due to physical illness. Study limitations include lack of power to evaluate gender-specific effects, lack of long-term outcomes (e.g., 12 months post-treatment), and lack of cost-effectiveness information. 

Conclusions: In humanitarian emergencies with a lack of mental health specialists, a 5-session group psychological treatment delivered by non-specialists can be used to modestly reduce psychological distress and depression symptoms, with benefits partly explained by the degree of psychosocial skill use in daily life. To improve the treatment benefit, future implementation should focus on approaches to enhance skill use by PM+ participants.