Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises Nepal: study protocol for a cluster randomised controlled trial (c-RCT) [post]

2019 unpublished
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 5 sessions that can be delivered by non-specialists. It is designed for people in communities in low-and middleincome countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and
more » ... enya 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: 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 hour 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),
doi:10.21203/rs.2.10217/v2 fatcat:a66x34bmdfhb7hitqjfx7sochi