Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04453709 |
Other study ID # |
1837 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 17, 2021 |
Est. completion date |
May 2024 |
Study information
Verified date |
May 2023 |
Source |
University of Massachusetts, Amherst |
Contact |
Kalpana Poudel-Tandukar, PhD |
Phone |
4135455095 |
Email |
kalpana[@]umass.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.