Target Group : Men and women with depression and anxiety symptoms.
Problem Management Plus (PM+) is a brief 5-session trans-diagnostic psychological WHO intervention with strategies that can be delivered by non-specialist lay-providers to adults in distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. In order to make PM+ more salable and acceptable in different contexts it is important to develop a group version as well. The objective of this randomized control trial (RCT) in Nepal will inform whether WHO should release Group PM+ for global use.
In low resourced settings, such as Nepal, interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. WHO aims to develop a range of low-intensity scale-able psychological interventions that address these issues, as part of its mhGAP program.
In Nepal, the study will be divided into four phases: Study phase 1 is the manual adaptation to the local context; Study phase 2 is an exploratory single-blind cluster randomized controlled trial (RCT) in Sindhuli; Study phase 3 is a qualitative process evaluation of phase 2; Study phase 4 is a single-blind cluster RCT in Nuwakot; Study phase 5 is a qualitative process evaluation of phase 4.
To ensure the acceptability of any mental health intervention, it should be locally adapted before delivering it in a specific population. The local adaptation of the Group PM+ manual and training materials for Nepal will be informed by existing research on mental health in Nepal, a rapid qualitative assessment, and manual testing on different stakeholders during Phase 1.
In study phase 2, an exploratory cluster randomized controlled trial (cluster RCT) will be conducted to gather information about the feasibility, safety and delivery of the intervention in the Nepali community settings; and to identify issues around training, supervision and outcomes measures. Possible problems of acceptability, compliance, delivery of the intervention, recruitment and retention can be detected before the large definitive scale trail is conducted.
Study phases 3 and 5 will evaluate the barriers and facilitators among key stakeholders in implementing PM+. Study phase 3 will consist of key informant interviews with control arm and intervention arm end-users (completers and drop-outs), facilitators, supervisory and clinical staff, and assessors about their experience with PM+ in phase 2 of the project. Study phase 5 will consist of key informant interviews and intervention arm end-users (completers and drop-outs), facilitators, supervisory and clinical staff, family members of participants, and local decision makers. Study phase 4 will consist of a single-blind cluster RCT to evaluate effectiveness of Group PM+.
This outcome will inform the definite cluster RCT which will produce outcome on the effectiveness of the Group PM+ intervention in Nepal. Assuming the intervention is proven effective WHO will release it for global use.