- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416059
A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking
June 3, 2024 updated by: Michael J. Zvolensky, Ph.D., University of Houston
A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking
The purpose of this study is to develop and examine a culturally adapted, brief, integrated mobile health application for the Android and iOS platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions.
Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing.
Finally, Black hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects.
Initial screening will be conducted via Zoom; baseline and post-treatment data will be collected via Zoom and 1-week, 1-month, and 3-months follow-up data will be collected remotely.
Study Type
Interventional
Enrollment (Estimated)
50
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: Brooke Y Redmond, Ph.D.
- Phone Number: 713-743-8056
- Email: byredmond@cougarnet.uh.edu
Study Contact Backup
- Name: Michael J Zvolensky, Ph.D.
- Phone Number: 713-743-8595
- Email: mjzvolen@central.uh.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Recruiting
- RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
-
Principal Investigator:
- Michael J Zvolensky, Ph.D.
-
Contact:
- Maxwell S Suffis, M.A.
- Phone Number: 206-795-8350
- Email: mssuffis@cougarnet.uh.edu
-
Principal Investigator:
- Richard A Brown, Ph.D.
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being 21 years of age or older
- Self-identifying as Black or African American
- Meeting criteria for current hazardous drinking pattern
- Meeting criteria for clinical anxiety
- Being able to provide written, informed consent
- Owning a smartphone.
Exclusion Criteria:
- Current participation in alcohol or other substance abuse treatment
- Engaged in psychotherapy for anxiety or depression
- Concurrent use of medication for anxiety or depression
- Being pregnant by self-report
- Residence outside of the United States confirmed via survey geolocation
- Inability to provide a valid United States-issued driver's license or identification card to verify identity.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile Application
Participants complete a 45 minute intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.
|
The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Use Disorders Identification Test
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use.
The 10 items are rated with various Likert-type scales.
The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40).
A higher score indicates a worse outcome.
|
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
Overall Anxiety Severity and Impairment Scale
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment.
Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20).
A higher score indicates a worse outcome.
|
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to Reduce Alcohol Consumption Scale
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol.
Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month").
Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7).
|
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
Modified Drinking Motives Questionnaire-Revised
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking.
For the current study, the 28-item questionnaire will be used as a measure of expectancies of drinking to reduce/cope with anxiety.
The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always).
Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5).
|
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
Alcohol Attitudes Scale
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good").
Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree).
Scores will be averaged to create a composite score (possible range 1 to 7).
Higher scores indicate greater maladaptive attitudes for drinking.
|
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Zvolensky, Ph.D., University of Houston
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)
June 1, 2024
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
May 10, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
June 3, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004389
- R41AA031398 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are currently no plans to make individual participant data (IPD) available to other researchers.
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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