ArticlePilot and feasibility studies2026
Study protocol of a pilot randomised controlled trial examining massed culturally adapted Problem Management Plus (PM +) in South Africa.
Article in Pilot and feasibility studies, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundProblem 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.
methodsThe 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 registrationPan African Clinical Trials Registry, PACTR202110484536189. Registered retrospectively on 25 October 2021.
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