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Completed

NCT Number: NCT04453709

Family-centered Mental Health Promotion Intervention

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.

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Key information

Conditions

Stress, Psychological Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress, Physiological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Management Plus for Immigrants at family settings

Behavioral

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)

Behavioral

Pamphlet including list of community support service institutions

Primary outcomes

  1. Cohen Perceived Stress Scale to Measure Stress

    Time frame: 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.

  2. Hopkins Symptom Checklist-25 to Measure Anxiety

    Time frame: 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.

  3. Hopkins Symptom Checklist-25 to Measure Depressive Symptoms

    Time frame: 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 outcomes

  1. Hair Cortisol Concentrations (pg/mg)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • Vanderbilt University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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