Family-centered Mental Health Promotion Intervention

NCT04453709 | Completed Results DMC

• 1 other identifier: 1837
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Stress, Physiological; Anxiety; Depression

Keywords

Stress; Anxiety; Depression; Preventative Intervention

Outcome Measures

Primary Outcomes (3)

• Cohen Perceived Stress Scale to Measure Stress

  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.

  Baseline

• Hopkins Symptom Checklist-25 to Measure Anxiety

  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.

  Baseline

• Hopkins Symptom Checklist-25 to Measure Depressive Symptoms

  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.

  Baseline

Secondary Outcomes (1)

• Hair Cortisol Concentrations (pg/mg)

  Baseline

Study Arms (2)

Problem Management Plus for Immigrants at family settings

EXPERIMENTAL

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

Talk program with Community Support Service Pamphlet (CSS)

ACTIVE COMPARATOR

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)

Interventions

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. 1. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies. 2. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions. 3. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks. 4. Strengthening Social Support: Social skills session and practice exercise to identify social support. 5. Staying Well: Make a plan that helps to create supportive family environment.

Problem Management Plus for Immigrants at family settings

Talk program with Community Support Service Pamphlet (CSS) BEHAVIORAL

Pamphlet including list of community support service institutions

Talk program with Community Support Service Pamphlet (CSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bhutanese adult 18 years or older resettled in Massachusetts
• Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)

You may not qualify if:

• Have a PHQ-9 score of 15 or above
• Clinically diagnosed mental health disorders
• Taking psychiatric medications for any mental health problems

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• Vanderbilt University: collaborator

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

Related Publications (1)

• 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.

  PMID: 35504635 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Kalpana Poudel-Tandukar, Associate Professor
• Organization: University of Massachusetts Amherst

kalpana@umass.edu

413-545-5095

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 1, 2020
• Study Start: August 17, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.
• 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.

Locations

US (1)