Problem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya; study protocol for a randomized controlled trial

Background: Women affected by adversity, including gender-based violence, are at increased risk for developing common mental disorders such as depression, anxiety and posttraumatic stress disorder (PTSD). The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, that can be delivered by non-specialist counsellors that addresses common mental disorders in people affected by adversity. The objectives of this study are to evaluate effectiveness of PM+ among women who have been affected by adversity, including gender-based violence, and to perform a process evaluation. Methods: Informed by community consultations, the PM+ manual has been translated and adapted to the local context. A randomized controlled trial will be carried out in the catchment areas of three local health care facilities in Dagoretti Sub County, Nairobi. After informed consent, females 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+ (n = 247) or enhanced treatment as usual (n = 247). Post-treatment and 3-months post-treatment follow-up assessments include psychological distress, functional disability, PTSD symptoms, perceived problems for which the person seeks help, health care use and health costs. For evaluating the process of implementing PM+ within local communities in Nairobi 20 key informant interviews will be carried out in participants, PM+ providers, decision makers, clinical staff. Discussion: If PM+ is proven effective, it will be rolled out to other low and middle income areas and other populations for further adaptation and testing. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000032459. Registered prospectively on January 18, 2016