Testing the feasibility, acceptability, and exploring trends on efficacy of the problem management plus for moms: Protocol of a pilot randomized control trial.

Mental health disorders are one of the most common causes that limit the ability of mothers to care for themselves and for their children. Recent data suggest high rates of distress among women in charge of young children in Zambia. Nevertheless, Zambia's public healthcare offers very limited treatment for common mental health distress. To address this treatment gap, this study aims to test the feasibility, acceptability, and potential efficacy of a context-adapted psychosocial intervention. A total of 265 mothers with mental health needs (defined as SRQ-20 scores above 7) were randomly assigned with equal probability to the intervention or control group. The intervention group will receive a locally adapted version of the Problem-Management Plus and "Thinking Healthy" interventions developed by the World Health Organization (WHO), combined with specific parts of the Strong Minds-Strong Communities intervention. Trained and closely supervised wellbeing-community health workers will provide the psychosocial intervention. Mental health distress and attendance to the intervention will be assessed at enrollment and 6 months after the intervention. We will estimate the impact of the intervention on mental health distress using an intention-to-treat approach. We previously found that there is a large necessity for interventions that aim to address mother anxiety/depression problems. In this study, we tested the feasibility and efficacy of an innovative intervention, demonstrating that implementing these mental health treatments in low-income settings, such as Zambia, is viable with an adequate support system. If successful, larger studies will be needed to test the effectiveness of the intervention with increased precision. Trial registration: This study is registered at clinicaltrials.gov as NCT05627206.