NCT04453709

Family-centered Mental Health Promotion Intervention

Completed NA Results posted Last updated 17 October 2024

What this trial tests

NA trial testing Problem Management Plus for Immigrants at family settings in Stress, Psychological in 232 participants. Completed in 15 November 2022.

Timeline

17 August 2021

Primary endpoint
15 November 2022

15 November 2022

Quick facts

Lead sponsor	University of Massachusetts, Amherst
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	232
Start date	17 August 2021
Primary completion	15 November 2022
Estimated completion	15 November 2022
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Stress, Physiological — all drugs for Stress, Physiological →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

University of Massachusetts, Amherst

Who can join

18 and older, any sex, with Stress, Psychological or Stress, Physiological. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cohen Perceived Stress Scale to Measure Stress Primary · 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.

Group	Value	95% CI
Problem Management Plus for Immigrants at Family Settings	23.28	± 3.70
Talk Program With Community Support Service Pamphlet (CSS)	19.31	± 4.87

Hopkins Symptom Checklist-25 to Measure Anxiety Primary · 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.

Group	Value	95% CI
Problem Management Plus for Immigrants at Family Settings	21.57	± 3.25
Talk Program With Community Support Service Pamphlet (CSS)	15.37	± 5.08

Hopkins Symptom Checklist-25 to Measure Depressive Symptoms Primary · 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.

Group	Value	95% CI
Problem Management Plus for Immigrants at Family Settings	32.11	± 4.89
Talk Program With Community Support Service Pamphlet (CSS)	22.56	± 6.24

Hair Cortisol Concentrations (pg/mg) Secondary · 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.

Group	Value	95% CI
Problem Management Plus for Immigrants at Family Settings	349.37	± 2627.98
Talk Program With Community Support Service Pamphlet (CSS)	78.35	± 324.36

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Poudel-Tandukar K, Jacelon CS, Martell CR, Poudel KC, et al · · 2022 · PMID 35504635 · DOI 10.1136/bmjopen-2022-061353