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Family-centered Mental Health Promotion for Stress and Anxiety Disorders
N/A
Waitlist Available
Research Sponsored by University of Massachusetts, Amherst
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bhutanese adult 18 years or older resettled in Massachusetts
Be older than 18 years old
Must not have
Taking psychiatric medications for any mental health problems
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the effectiveness of a preventative behavioral intervention called Problem Management Plus for Immigrants (PMP-I) to see if it can reduce stress and mental health disorders in immigrants.
Who is the study for?
This trial is for Bhutanese adults aged 18 or older who have resettled in Massachusetts and are experiencing mild stress, anxiety, or depression symptoms (scoring 14 or below on the PHQ-9). It's not open to those with severe mental health issues, a clinical diagnosis of a mental disorder, or those on psychiatric medications.
What is being tested?
The study tests Problem Management Plus for Immigrants (PMP-I), which includes breathing exercises, problem-solving skills, activity planning, and strengthening social support. It will be compared to a talk program supplemented by Community Support Service pamphlets. The goal is to see if PMP-I can better reduce stress and mood symptoms among immigrants.
What are the potential side effects?
Since this intervention involves behavioral techniques rather than medication, side effects may include discomfort from discussing personal issues or temporary increases in distress as one learns new coping strategies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a Bhutanese adult over 18 living in Massachusetts.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication for a mental health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohen Perceived Stress Scale to Measure Stress
Hopkins Symptom Checklist-25 to Measure Anxiety
Hopkins Symptom Checklist-25 to Measure Depressive Symptoms
Secondary study objectives
Hair Cortisol Concentrations (pg/mg)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Problem Management Plus for Immigrants at family settingsExperimental Treatment1 Intervention
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.
Group II: Talk program with Community Support Service Pamphlet (CSS)Active Control1 Intervention
Family receives pamphlet including list of community support service institutions that provide various health and well-being services.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Problem Management Plus for Immigrants at family settings
2021
N/A
~240
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,070 Total Patients Enrolled
University of Massachusetts, AmherstLead Sponsor
81 Previous Clinical Trials
467,918 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for a mental health condition.I am a Bhutanese adult over 18 living in Massachusetts.
Research Study Groups:
This trial has the following groups:- Group 1: Talk program with Community Support Service Pamphlet (CSS)
- Group 2: Problem Management Plus for Immigrants at family settings
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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