N/A N=232 Randomized Prevention

Family-centered Mental Health Promotion Intervention

Stress, Psychological · Stress, Physiological · Anxiety · Depression

Bottom Line

View on ClinicalTrials.gov: NCT04453709 ↗

Enrolled (actual)

232

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Cohen Perceived Stress Scale to Measure Stress — 23.28; 19.31 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Problem Management Plus for Immigrants at family settings (Behavioral); Talk program with Community Support Service Pamphlet (CSS) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Massachusetts, Amherst
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Cohen Perceived Stress Scale to Measure Stress	23.28; 19.31	—
PRIMARY Hopkins Symptom Checklist-25 to Measure Anxiety	21.57; 15.37	—
PRIMARY Hopkins Symptom Checklist-25 to Measure Depressive Symptoms	32.11; 22.56	—
SECONDARY Hair Cortisol Concentrations (pg/mg)	349.37; 78.35	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04453709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.