Family-centered Mental Health Promotion Intervention

Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Stress, Psychological; Anxiety; Stress, Physiological
• Intervention / Treatment: Behavioral: Problem Management Plus for Immigrants at family settings; Behavioral: Talk program with Community Support Service Pamphlet (CSS)

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 Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kalpana Poudel-Tandukar, PhD; Phone Number: 4135455095; Email: kalpana@umass.edu
• Study Contact Backup: Name: Cynthia S Jacelon; Phone Number: 4135459576; Email: jacelon@nursing.umass.edu

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • Recruiting
      • University of Massachusetts Amherst
      • Contact: Kalpana Poudel-Tandukar, Ph.D; Phone Number: 413-545-5095; Email: kalpana@umass.edu
      • Contact: Cynthia S Jacelon; Phone Number: 413 545 9576; Email: jacelon@nursing.umass.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Perceived Stress Scores	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.	Baseline, immediate post-intervention and 12-week post intervention
Change in the Anxiety and Depressive Symptoms Scores	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).	Baseline, immediate post-intervention and 12-week post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Hair Cortisol Concentrations	Cortisol hair-test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress.	Baseline and 12-week post intervention

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: Vanderbilt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; Preventative Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders; Stress, Psychological
• Other Study ID Numbers: 1837 (Region Skane ALF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlies published results will be shared after deidentification.
• IPD Sharing Time Frame: IPD will be made available after the main findings from the final research data set have been accepted for publication. No end date.
• IPD Sharing Access Criteria: Access to IPD can be requested by qualified researchers engaging in independent scientific research, and will be disseminated in accordance with University/Participating institutional and NIH policies, including entering into a Data Sharing Agreement. Inquiries for should be sent to the Principal Investigator.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No