Family-centered Mental Health Promotion Intervention

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04453709
• Other study ID #: 1837
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Stress, Physiological
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts Amherst	Amherst	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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