Personalized Feedback Intervention for Latinx Drinkers With Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of Houston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Being involved in alcohol or other substance use program
Currently pregnant
Current engagement in psychotherapy for anxiety
Trial design
Design model
Parallel
Treatments tested in this trial
Alcohol-Anxiety Personalized Feedback Intervention 2.0
BehavioralAA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.
Control Personalized Feedback Intervention
BehavioralC-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)Experimental treatment 1 intervention
Group B: Control personalized feedback intervention (C-PFI)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion2
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).
Time frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion3
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.
Time frame
Change from Baseline Pre PFI completion to Baseline Post PFI completionSecondary outcomes
1
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).
Time frame
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion2
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).
Time frame
Change from Baseline Pre PFI Completion to 6-months Post PFI CompletionSponsors and contacts
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University of Houston
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov