ClinicalTrials.Veeva

Menu

Family-centered Mental Health Promotion Intervention

University of Massachusetts, Amherst logo

University of Massachusetts, Amherst

Status

Completed

Conditions

Depression
Anxiety
Stress, Physiological
Stress, Psychological

Treatments

Behavioral: Talk program with Community Support Service Pamphlet (CSS)
Behavioral: Problem Management Plus for Immigrants at family settings

Study type

Interventional

Funder types

Other

Identifiers

NCT04453709
1837 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

232 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 2 patient groups

Problem Management Plus for Immigrants at family settings
Experimental group
Description:
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.
Treatment:
Behavioral: Problem Management Plus for Immigrants at family settings
Talk program with Community Support Service Pamphlet (CSS)
Active Comparator group
Description:
Family receives pamphlet including list of community support service institutions that provide various health and well-being services.
Treatment:
Behavioral: Talk program with Community Support Service Pamphlet (CSS)

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Kalpana Poudel-Tandukar, PhD; Cynthia S Jacelon

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems