- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246202
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
October 24, 2022 updated by: Michael J. Zvolensky, Ph.D., University of Houston
Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted 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 Latinx hazardous drinkers with anxiety.
Study Overview
Status
Recruiting
Conditions
Detailed Description
In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI).
In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI).
Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.
Study Type
Interventional
Enrollment (Anticipated)
250
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 Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Recruiting
- RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
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-
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
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being between the age of 21 to 75 years of age
- Being self-identified as Latinx or Hispanic
- Fluent in Spanish
- Meeting criteria for current hazardous drinking pattern
- Meeting criteria for clinical anxiety
- Being able to provide written, informed consent
Exclusion Criteria:
- Being involved in alcohol or other substance use program
- Currently pregnant
- Current engagement in psychotherapy for anxiety
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)
Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline.
|
AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.
Other Names:
|
Active Comparator: Control personalized feedback intervention (C-PFI)
Participants complete the brief (~20-30 minute) C-PFI at baseline.
|
C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to Reduce Alcohol Consumption Scale
Time Frame: Change from Baseline Pre PFI completion to Baseline 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 Baseline Post PFI completion
|
Modified Drinking Motives Questionnaire-Revised
Time Frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
|
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking.
For the current study, the 4-item "Coping-anxiety" subscale 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 Baseline Post PFI completion
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Alcohol Attitudes Scale
Time Frame: Change from Baseline Pre PFI completion to Baseline 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 Baseline Post PFI completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Anxiety Severity and Impairment Scale
Time Frame: Change from Baseline Pre PFI Completion to 6-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).
|
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
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Alcohol Use Disorders Identification Test
Time Frame: Change from Baseline Pre PFI Completion to 6-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).
|
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 9, 2022
Primary Completion (Anticipated)
May 31, 2026
Study Completion (Anticipated)
May 31, 2026
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
February 14, 2022
First Posted (Actual)
February 18, 2022
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003237
- 1R01AA029807-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan 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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