Study protocol of a pilot randomised controlled trial examining massed culturally adapted Problem Management Plus (PM +) in South Africa

BACKGROUND: Problem Management Plus (PM +) is a low-intensity psychological intervention developed by the World Health Organization to reduce psychological distress, particularly in settings with limited access to mental health care. To date, PM + has not been culturally adapted for the Xhosa community in South Africa, nor has it been evaluated in a massed format (five daily sessions delivered within 1 week). This study aims to culturally adapt PM + for the Xhosa context and to assess the feasibility and acceptability of a massed delivery format. METHODS: The study will be conducted in three phases. Phase 1 will involve qualitative semi-structured interviews with key stakeholders and health professionals from the Xhosa community to inform the cultural adaptation of PM +. Phase 2 will consist of a pilot randomised controlled trial (N = 60) with participants experiencing psychological distress recruited at an Non-Profit Organisation (NPO) called Sakhe Family Care Development Centre in Kwa-Nomzamo, Humansdorp. Participants will be randomised to receive either (a) PM + (n = 30) or (b) care-as-usual only (n = 30). As this pilot is not powered to detect effectiveness, analyses will be exploratory and aimed at assessing feasibility, acceptability, and implementation potential. Phase 3 will comprise a qualitative process evaluation with PM + participants, PM + helpers, and key stakeholders. DISCUSSION: The findings will identify barriers and facilitators to delivering PM + in a massed format and provide preliminary insights to guide iterative adaptations and future fully powered trials of effectiveness and cost-effectiveness in South Africa. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR202110484536189. Registered retrospectively on 25 October 2021.