Family-centered Mental Health Promotion Intervention

NCT ID: NCT04453709

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2022-11-15

Brief Summary

Goal: The long-term goal of the proposed research program is to test the effectiveness of a preventative behavioral intervention and to scale it up for use with broader immigrant populations to reduce stress and mental health disorders.

Intervention: This study plan to adapt the World Health Organization developed Problem Management Plus (PMP), an evidence based, multi-component, behavioral intervention including breathing, problem solving, behavioral activation, and social support for immigrants.

Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will have significantly lower levels of stress and anxious/depressive symptoms as compared to immigrants in the talk program with Community Support Service pamphlets (CSS).

Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I among Bhutanese immigrants 18 years and older living in the Massachusetts.

Detailed Description

Problem Management Plus (PMP) is a low-intensity evidence-based psychological intervention developed by World Health Organization that can be delivered by trained lay people. PMP systematically teaches four strategies: stress management through breathing exercises, problem solving, behavioral activation, and skills to strengthen social support at individual level. The current study plans to adapt PMP to develop the PMP for Immigrants (PMP-I) for a family setting to address immigrant's multiple social and emotional stressors while adjusting into the new multi-cultural environment of the United States. The rationale to adapt PMP is based on our intervention model that demands integration of social and emotional stressors; promising results of PMP; strong evidence of family and community ties in health care process; and growing consensus among community, scientists, and policymakers on the need for family-based care models that are sustainable. PMP-I is a 5-week, peer-led, culturally tailored mental health promotion program that includes psychoeducation, behavioral activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga (90 minutes/session/weekly) in a family setting. Participating families will be randomly allocated into two groups (N=116 families (232 participants: two eligible members per family); 58 families per intervention (PMP-I) and control (CSS)) with assessments at baseline, post-intervention, and 3-month post-intervention with trained community facilitators in collaboration with church leaders.

Conditions

Stress, Psychological; Stress, Physiological; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Problem Management Plus for Immigrants at family settings

PMP-I intervention aims to develop skills in coping adaptively in a new culture, seeking help and support for mental health problems, and other life skills opportunities that can help to improve their quality of life. PMP-I intervention includes stress management through breathing exercises and yoga, problem solving, behavioral activation, and skills to strengthen social support.

Group Type: EXPERIMENTAL

Problem Management Plus for Immigrants at family settings

Intervention Type: BEHAVIORAL

PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.

1. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.

2. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.

3. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.

4. Strengthening Social Support: Social skills session and practice exercise to identify social support.

5. Staying Well: Make a plan that helps to create supportive family environment.

Talk program with Community Support Service Pamphlet (CSS)

Family receives pamphlet including list of community support service institutions that provide various health and well-being services.

Group Type: ACTIVE_COMPARATOR

Talk program with Community Support Service Pamphlet (CSS)

Intervention Type: BEHAVIORAL

Pamphlet including list of community support service institutions

Interventions

Problem Management Plus for Immigrants at family settings

PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.

1. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.

2. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.

3. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.

4. Strengthening Social Support: Social skills session and practice exercise to identify social support.

5. Staying Well: Make a plan that helps to create supportive family environment.

Intervention Type: BEHAVIORAL

Talk program with Community Support Service Pamphlet (CSS)

Pamphlet including list of community support service institutions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Bhutanese adult 18 years or older resettled in Massachusetts
• Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)

Exclusion Criteria

• Have a PHQ-9 score of 15 or above
• Clinically diagnosed mental health disorders
• Taking psychiatric medications for any mental health problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: lead

Responsible Party

Kalpana Poudel-Tandukar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Massachusetts Amherst

Amherst, Massachusetts, United States

Countries

United States

References

Poudel-Tandukar K, Jacelon CS, Martell CR, Poudel KC, Rai S, Ramdam R, Laws H, Meyer JS, Bertone-Johnson ER, Hollon SD. 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. BMJ Open. 2022 May 3;12(5):e061353. doi: 10.1136/bmjopen-2022-061353.

Reference Type: DERIVED

PMID: 35504635 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1837

Identifier Type: -

Identifier Source: org_study_id