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Family-centered Mental Health Promotion Intervention

Primary Purpose

Stress, Psychological, Stress, Physiological, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Management Plus for Immigrants at family settings
Talk program with Community Support Service Pamphlet (CSS)
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Stress, Anxiety, Depression, Preventative Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts AmherstRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem Management Plus for Immigrants at family settings

Talk program with Community Support Service Pamphlet (CSS)

Arm Description

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.

Family receives pamphlet including list of community support service institutions that provide various health and well-being services.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2020
Last Updated
May 8, 2023
Sponsor
University of Massachusetts, Amherst
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04453709
Brief Title
Family-centered Mental Health Promotion Intervention
Official Title
Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Anxiety, Depression
Keywords
Stress, Anxiety, Depression, Preventative Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Problem Management Plus for Immigrants at family settings
Arm Type
Experimental
Arm Description
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.
Arm Title
Talk program with Community Support Service Pamphlet (CSS)
Arm Type
Active Comparator
Arm Description
Family receives pamphlet including list of community support service institutions that provide various health and well-being services.
Intervention Type
Behavioral
Intervention Name(s)
Problem Management Plus for Immigrants at family settings
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Talk program with Community Support Service Pamphlet (CSS)
Intervention Description
Pamphlet including list of community support service institutions
Primary Outcome Measure Information:
Title
Change in the Perceived Stress Scores
Description
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.
Time Frame
Baseline, immediate post-intervention and 12-week post intervention
Title
Change in the Anxiety and Depressive Symptoms Scores
Description
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).
Time Frame
Baseline, immediate post-intervention and 12-week post intervention
Secondary Outcome Measure Information:
Title
Change in the Hair Cortisol Concentrations
Description
Cortisol hair-test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress.
Time Frame
Baseline and 12-week post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kalpana Poudel-Tandukar, PhD
Phone
4135455095
Email
kalpana@umass.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia S Jacelon
Phone
4135459576
Email
jacelon@nursing.umass.edu
Facility Information:
Facility Name
University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalpana Poudel-Tandukar, Ph.D
Phone
413-545-5095
Email
kalpana@umass.edu
First Name & Middle Initial & Last Name & Degree
Cynthia S Jacelon
Phone
413 545 9576
Email
jacelon@nursing.umass.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://grants.nih.gov/grants/policy/data_sharing/
Citations:
PubMed Identifier
35504635
Citation
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.
Results Reference
derived

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Family-centered Mental Health Promotion Intervention

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