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NCT04453709 · ClinicalTrials.gov registry record · NA
Family-centered Mental Health Promotion Intervention
A NA study of Depression and Anxiety, sponsored by University of Massachusetts, Amherst.
- Completed
- Registry status
- NA
- Development phase
- 232
- Enrollment target
- 1
- Study location
NCT04453709: Completed NA study of Depression and Anxiety, sponsored by University of Massachusetts, Amherst.
NCT04453709 is a NA study of Depression and Anxiety that has completed, run by University of Massachusetts, Amherst. The registered enrollment target is 232 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04453709, a NA study of Depression and Anxiety, has completed, sponsored by University of Massachusetts, Amherst.
- COMPLETED
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Problem Management Plus for Immigrants at family settings
- BEHAVIORAL Talk program with Community Support Service Pamphlet (CSS)
Study Locations (1)
Massachusetts
- University of Massachusetts Amherst - Amherst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2021-08-17 |
| Est. Completion | 2022-11-15 |
| Phase | NA |
What the finished NCT04453709 record still lists
NCT04453709 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (70% lower).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Problem Management Plus for Immigrants at family settings is the first listed.
NCT04453709 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04453709 about?
NCT04453709 is a clinical study titled "Family-centered Mental Health Promotion Intervention". 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 Organi...
What is the current status of trial NCT04453709?
This trial is currently completed. It is a NA study. The enrollment target is 232 participants. The study started on 2021-08-17. Estimated completion is 2022-11-15.
What conditions does trial NCT04453709 study?
This clinical trial studies the following conditions: Depression, Anxiety, Stress, Psychological, Stress, Physiological.
What interventions are being tested in trial NCT04453709?
The interventions under investigation include: Problem Management Plus for Immigrants at family settings (BEHAVIORAL), Talk program with Community Support Service Pamphlet (CSS) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04453709?
This trial is sponsored by University of Massachusetts, Amherst, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04453709 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04453709's enrollment target sits among peer trials
232 188th of 679 higher than 492 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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