Family-centered Mental Health Promotion Intervention

Not Applicable

Completed

Conditions: Depression
Anxiety
Stress, Psychological
Stress, Physiological

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

Registration Number: NCT04453709

Lead Sponsor: University of Massachusetts, Amherst

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 232

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talk program with Community Support Service Pamphlet (CSS)	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.
Problem Management Plus for Immigrants at family settings	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.

Primary Outcome Measures

Name	Time	Method
Cohen Perceived Stress Scale to Measure Stress	Baseline	The 10-item Cohen Perceived Stress Scale will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The Cohen Perceived Stress Scale 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. The total high scores indicate a worse outcome. The score range is between 0 and 40.
Hopkins Symptom Checklist-25 to Measure Anxiety	Baseline	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). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60.
Hopkins Symptom Checklist-25 to Measure Depressive Symptoms	Baseline	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). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60.

Secondary Outcome Measures

Name	Time	Method
Hair Cortisol Concentrations (pg/mg)	Baseline	Cortisol hair test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress. Higher hair cortisol concentrations indicate a higher level of biological stress in the body. The range of values is between 0.799 and 2554.68 pg/mg.