Clinical trial NCT04453709: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Anxiety
Depression
Keywords: Stress
Anxiety
Depression
Preventative Intervention
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2020-07-01
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cohen Perceived Stress Scale to Measure Stress
timeFrame: Baseline
measure: Hopkins Symptom Checklist-25 to Measure Anxiety
timeFrame: Baseline
measure: Hopkins Symptom Checklist-25 to Measure Depressive Symptoms
timeFrame: Baseline
Secondary outcomes:
measure: Hair Cortisol Concentrations (pg/mg)
timeFrame: Baseline
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
References:
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.