- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04890977
Engaging Pacific Islanders in Mental Health Treatment
June 8, 2022 updated by: University of California, Riverside
Engaging Pacific Islanders in Mental Health Treatment Services
This study will create and pilot test a culturally grounded intervention (Talking Story) to increase mental health treatment seeking among Pacific Islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilottest of the culturally grounded Talking Story mental health treatment-seeking intervention with 48 Pacific Islander participants (24 intervention arm, 24 wait-list control) in preparation for larger R01 randomized wait-list controlled testing.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew M Subica, Ph.D.
- Phone Number: 808-936-9806
- Email: asubica@medsch.ucr.edu
Study Locations
-
-
California
-
Riverside, California, United States, 91784
- Recruiting
- UC Riverside
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Of Pacific Islander or part Pacific Islander heritage,
- Must be over 18 years of age,
- Live in Los Angeles County or surrounding areas,
- Fluent (oral and reading) in English,
- Not have dual comorbidities in major depressive disorder, generalized anxiety disorder, and/or alcohol use disorder (they may have one of these disorders and still participate but not two or three).
Exclusion Criteria:
- Do not meet inclusion criteria,
- Are unwilling to participate,
- Fail to provide or retracts consent,
- Reside outside the target communities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Talking Story
Talking Story is a modular behavioral intervention intended to increase mental health treatment-seeking among Pacific Islanders through the use of narrative films and other culturally syntonic approaches.
|
A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.
|
Placebo Comparator: Wait-list control
The wait-list control will be administered as a control arm to the active Talking Story arm.
|
A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KAP Model
Time Frame: Up to 12 months
|
Knowledge, Attitudes, and Practices related to seeking mental health treatment
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
May 12, 2021
First Submitted That Met QC Criteria
May 12, 2021
First Posted (Actual)
May 18, 2021
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH122641 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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