DepressionNCT04890977
Engaging Pacific Islanders in Mental Health Treatment
A study testing Talking Story in people with Depression and Anxiety Disorders, run by University of California, Riverside at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Talking Story
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Do not meet inclusion criteria,
- Are unwilling to participate,
- Fail to provide or retracts consent,
- Reside outside the target communities.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC Riverside
Riverside, California, 91784
Andrew Subica, 808-936-9806, asubica@medsch.ucr.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Talking Story
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking StoryBehavioural
A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.
| Study group | Role | What they receive |
|---|---|---|
| Talking Story | Experimental | 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. Receives: Behavioral: Talking Story |
| Wait-list control | Placebo comparator | The wait-list control will be administered as a control arm to the active Talking Story arm. Receives: Behavioral: Talking Story |
What is being measured
The primary outcome is the main question the study is designed to answer.
KAP Model
Knowledge, Attitudes, and Practices related to seeking mental health treatment
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890977
- Sponsor's protocol ID
- R34MH122641
- Status last verified
- May 2022
- First submitted
- 12 May 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Pacific Islanders in Mental Health Treatment Services
- ClinicalTrials.gov ID
- NCT04890977
- Acronym / sponsor ID
- R34MH122641
- Conditions
- Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talking Story | Experimental | Behavioral: Talking StoryTalking 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. |
| Wait-list control | Placebo comparator | Behavioral: Talking StoryThe wait-list control will be administered as a control arm to the active Talking Story arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Do not meet inclusion criteria,
- Are unwilling to participate,
- Fail to provide or retracts consent,
- Reside outside the target communities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking StoryA culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders. | Behavioural | Talking Story, Wait-list control |
Primary outcome
KAP Model
Time frame: Up to 12 months
Knowledge, Attitudes, and Practices related to seeking mental health treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Story in people with Depression and Anxiety Disorders, run by University of California, Riverside at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew M Subica, Ph.D. (808-936-9806, asubica@medsch.ucr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KAP Model (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.