Peer-delivered systems-integrated suicide prevention for women in Pakistan: a protocol for hybrid type II pilot cluster randomized controlled trial

BACKGROUND: South Asia has the highest rates of suicide fatalities among women globally. Existing suicide prevention interventions are largely based on Western-informed risk reduction programs and theories. This pilot trial aims to test the acceptability and feasibility of a co-designed suicide prevention program for peri-rural Pakistani women called the Khushal Pur-Umeed Zindagi (KPZ, خوشحال پُرامید زندگی پروگرام), compared to enhanced usual care (EUC). The study seeks to innovate suicide prevention by grounding interventions in decolonized frameworks, leveraging peer mothers, and developing robust health system integration strategies. METHODS: We will conduct a two-arm, mixed-methods, hybrid type 2, stratified pilot cluster randomized controlled trial in peri-rural areas of the Islamabad Capital Territory (ICT). KPZ is a decolonized, culturally salient brief intervention combining narrative-based safety planning and contact follow-up, delivered by peer mothers over 6 months. EUC entails the WHO Mental Health Gap Action Programme (mhGAP) suicide prevention module, along with referral support delivered through Primary Health Care (PHC) by Medical Officers (n = 2) and Lady Health Worker teams (n = 11). KPZ is integrated into the PHC system and is implemented through close collaboration between peer mothers (delivery agents) and the government-employed LHWs. A cohort of peer mothers (n = 11), identified from the same communities as participants, will be trained and supervised for the study duration. We will enroll 50 women aged 18-45 with a child under 3 years who report suicidal ideation and will conduct follow-ups at 3- and 6-months post-recruitment. Qualitative interviews with trial participants and periodic reflections from peer mothers will be conducted iteratively over 6 months. A mixed-methods approach will be used to assess both clinical and implementation outcomes. Primary clinical outcomes include suicidal ideation severity and suicidal behaviors. Implementation outcomes include feasibility, acceptability, fidelity, appropriateness, and peer mothers' competence. Secondary outcomes assess additional clinical domains (depression, anxiety) and culturally relevant constructs (moral injury, cultural suicide cognitions). DISCUSSION: This pilot trial will provide evidence on the feasibility and acceptability of integrating a decolonized, peer-delivered suicide prevention program for women into the existing Pakistani health system. The findings have the potential for large-scale public health impact by improving the availability, accessibility, and quality of culturally appropriate suicide prevention interventions in resource-constrained and complex environments. Results will inform a larger definitive trial of a community-initiated suicide prevention program in Pakistan. TRIAL REGISTRATION: NCT06208293.