Alcohol AbuseNCT05246202
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
A study testing Alcohol-Anxiety Personalized Feedback Intervention 2.0 in people with Alcohol Abuse and Anxiety, run by University of Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Abuse, Anxiety
- What is being tested?
- Alcohol-Anxiety Personalized Feedback Intervention 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 11 May 2026
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being involved in alcohol or other substance use program
- Currently pregnant
- Current engagement in psychotherapy for anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
Houston, Texas, 77204
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Abuse, Anxiety
- Being tested
- Alcohol-Anxiety Personalized Feedback Intervention 2.0, Control Personalized Feedback Intervention
- Keywords
- Latinx, Hispanic, Personalized Feedback Intervention
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-Anxiety Personalized Feedback Intervention 2.0Behavioural
Also called AA-PFI 2.0
AA-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 InterventionBehavioural
Also called C-PFI
C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0) | Experimental | Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline. Receives: Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0 |
| Control personalized feedback intervention (C-PFI) | Active comparator | Participants complete the brief (~20-30 minute) C-PFI at baseline. Receives: Behavioral: Control Personalized Feedback Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Secondary outcomes (2)
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).
Measured: 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).
Measured: Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start30 Sep 2022
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael J Zvolensky, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246202
- Sponsor's protocol ID
- STUDY00003237
- Other IDs
- 1R01AA029807-01
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
- ClinicalTrials.gov ID
- NCT05246202
- Acronym / sponsor ID
- STUDY00003237
- Conditions
- Alcohol Abuse, Anxiety
- Keywords
- Latinx, Hispanic, Personalized Feedback Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 18 Feb 2022 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0) | Experimental | Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline. |
| Control personalized feedback intervention (C-PFI) | Active comparator | Behavioral: Control Personalized Feedback InterventionParticipants complete the brief (~20-30 minute) C-PFI at baseline. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Being involved in alcohol or other substance use program
- Currently pregnant
- Current engagement in psychotherapy for anxiety
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 |
|---|---|---|
| Alcohol-Anxiety Personalized Feedback Intervention 2.0Also: AA-PFI 2.0AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety. | Behavioural | Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0) |
| Control Personalized Feedback InterventionAlso: C-PFIC-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition. | Behavioural | Control personalized feedback intervention (C-PFI) |
Primary outcome
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).
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).
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.
2 secondary outcomes
Overall Anxiety Severity and Impairment Scale
Time frame: Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
Alcohol Use Disorders Identification Test
Time frame: Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Michael J Zvolensky, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-Anxiety Personalized Feedback Intervention 2.0 in people with Alcohol Abuse and Anxiety, run by University of Houston 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to Reduce Alcohol Consumption Scale (time frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion). The study lists 3 primary outcomes in all. 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 8 Oct 2026.