Family-centered Mental Health Promotion Intervention

Sponsor
University of Massachusetts, Amherst (Other)
Overall Status
Recruiting
CT.gov ID
NCT04453709
Collaborator
Vanderbilt University (Other)
232
1
2
14.5
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Problem Management Plus for Immigrants at family settings
  • Behavioral: Talk program with Community Support Service Pamphlet (CSS)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
232 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial
Actual Study Start Date :
Aug 17, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks. Strengthening Social Support: Social skills session and practice exercise to identify social support. Staying Well: Make a plan that helps to create supportive family environment.

Active Comparator: 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.

Behavioral: Talk program with Community Support Service Pamphlet (CSS)
Pamphlet including list of community support service institutions

Outcome Measures

Primary Outcome Measures

  1. Change in the Perceived Stress Scores [Baseline, immediate post-intervention and 12-week post intervention]

    The 10-item Cohen Perceived Stress Scale (PSS) will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The PSS uses a 5-point Likert scale (ranging from 0, "never" to 4, "very often") to assess psychological stress experienced during the past four weeks, including the extent to which situations felt unpredictable, uncomfortable, and overwhelming.

  2. Change in the Anxiety and Depressive Symptoms Scores [Baseline, immediate post-intervention and 12-week post intervention]

    The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely).

Secondary Outcome Measures

  1. Change in the Hair Cortisol Concentrations [Baseline and 12-week post intervention]

    Cortisol hair-test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Massachusetts Amherst Amherst Massachusetts United States 01003

Sponsors and Collaborators

  • University of Massachusetts, Amherst
  • Vanderbilt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kalpana Poudel-Tandukar, Assistant Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT04453709
Other Study ID Numbers:
  • 1837
First Posted:
Jul 1, 2020
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kalpana Poudel-Tandukar, Assistant Professor, University of Massachusetts, Amherst
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022