Personalized Feedback Intervention for Latinx Drinkers With Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention

Conditions
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Alcohol Abuse, Anxiety

Intervention / Treatment
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* Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0
* Behavioral: Control Personalized Feedback Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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)<br>Participants complete the brief ( 20-30 minute) AA-PFI 2.0 at baseline. | Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0<br>* AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.<br>* Other names: AA-PFI 2.0;|
| Active Comparator: Control personalized feedback intervention (C-PFI)<br>Participants complete the brief ( 20-30 minute) C-PFI at baseline. | Behavioral: Control Personalized Feedback Intervention<br>* C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.<br>* Other names: C-PFI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to Reduce Alcohol Consumption Scale | 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 | 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 | 
| Alcohol Attitudes Scale | 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 | 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 | 
| Alcohol Use Disorders Identification Test | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latinx, Hispanic, Personalized Feedback Intervention