ABSTRACT
INTRODUCTION: Research is needed to investigate preventive strategies to reduce mental health burden and assess effective implementation among immigrants. Problem management plus (PMP) is a low-intensity multicomponent psychological intervention developed by the World Health Organization (WHO) that trained laypeople can deliver. PMP has been adapted as a prevention intervention and developed as PMP for immigrants (PMP-I), including psychoeducation, problem-solving, behavioural activations and mind-body exercise, to address immigrants' multiple stressors. This pilot trial aims to assess the feasibility and acceptability of PMP-I and provide a preliminary estimate of the difference between PMP-I versus community support services pamphlets on the primary outcomes of interest (stress, anxiety and depressive symptoms) to inform the design of a large-scale intervention. METHODS AND ANALYSIS: The feasibility and acceptability of PMP-I will be assessed by measuring recruitment, session attendance, retention rates, programme acceptability and the fidelity of intervention delivery. This pilot trial will test preliminary effects of PMP-I vs community support services pamphlets in a randomised controlled trial (N=232 participants from 116 families (2 members/family); 58 families randomised to condition intervention or control) on stress, anxiety and depressive symptoms (primary outcomes), chronic physiological stress assessed in hair cortisol (secondary outcomes), and coping, family conflict resolution, and social networking (targets), with assessment at baseline, postintervention and 3-month postintervention. Eligibility criteria for the primary study participants include Bhutanese ≥18 years resettled in Massachusetts with a score of ≤14 on the Patient Health Questionnaire-9. All family members will be invited to participate in the family-based intervention (one session/week for 5 weeks). Multilevel modelling will compare the longitudinal change in outcomes for each treatment arm. ETHICS AND DISSEMINATION: The Institutional Review Board of the University of Massachusetts Amherst approved this study (Protocol: 1837). Written informed consent will be obtained from all participants. The study results will be used to inform the design of a large-scale intervention and will be disseminated in peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT04453709.
