Family-centered Mental Health Promotion Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stress, Psychological, Stress, Physiological, Anxiety, Depression

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem Management Plus for Immigrants at family settings<br>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<br>* 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.<br>|
| Active Comparator: Talk program with Community Support Service Pamphlet (CSS)<br>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)<br>* Pamphlet including list of community support service institutions<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Anxiety, Depression, Preventative Intervention