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Peer-led family-centred problem management plus for immigrants (PMP-I) for mental health promotion among immigrants in USA: protocol for a pilot, randomised controlled feasibility trial
  1. Kalpana Poudel-Tandukar1,
  2. Cynthia S Jacelon1,
  3. Christopher R Martell2,
  4. Krishna C Poudel3,
  5. Shan Rai4,
  6. Razu Ramdam4,
  7. Holly Laws2,
  8. Jerrold S Meyer2,
  9. Elizabeth R Bertone-Johnson5,
  10. Steven D Hollon6
  1. 1 Elaine Marieb College of Nursing, University of Massachusetts Amherst, Amherst, Massachusetts, USA
  2. 2 Department of Psychological and Brain Sciences, College of Natural Sciences, University of Massachusetts Amherst, Amherst, Massachusetts, USA
  3. 3 Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, Amherst, Massachusetts, USA
  4. 4 Bhutanese Christian Society of Western Massachusetts, Westfield, Massachusetts, USA
  5. 5 Department of Biostatistics and Epidemiology, School of Public Health and Health Sciences, University of Massachusetts Amherst, Amherst, Massachusetts, USA
  6. 6 Department of Psychology, Vanderbilt University, Nashville, Tennessee, USA
  1. Correspondence to Dr Kalpana Poudel-Tandukar; kalpana{at}umass.edu

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.

  • EPIDEMIOLOGY
  • MENTAL HEALTH
  • PSYCHIATRY
  • PREVENTIVE MEDICINE
https://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors KP-T conceived the study and drafted the study and trial protocols. All authors were involved in the design of the study; KP-T, CSJ, CRM, KCP, SR, RR, HL, JSM, ERB-J and SDH were involved in revising the study protocol for ethics review, and all authors were involved in commenting on and revising the trial protocol. All authors read and approved the final manuscript.

  • Funding This trial is funded by the National Institute of Mental Health of the National Institutes of Health under Award Number R34MH118396 (PI: KP-T).

  • Disclaimer The content is solely the authors’ responsibility and does not necessarily represent the official views of the National Institutes of Health.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.