Personalized Feedback Intervention for Anxiety and Hazardous Drinking

Overseen By Brooke Y Kauffman, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Disqualifiers: Substance use program, Pregnant, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a single-session, computer-based program designed to assist Latinx individuals with anxiety and hazardous drinking habits. The program, Alcohol-Anxiety Personalized Feedback Intervention 2.0, provides personalized feedback to increase awareness of the connection between anxiety and alcohol use and to motivate participants to reduce their drinking. It targets individuals who identify as Latinx or Hispanic, speak Spanish fluently, and currently experience both high anxiety and risky drinking patterns. Participants will receive either this specific intervention or a control version for comparison. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research aimed at improving mental health and reducing alcohol-related risks in the Latinx community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are involved in an alcohol or substance use program or currently in psychotherapy for anxiety, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Alcohol-Anxiety Personalized Feedback Intervention 2.0 (AA-PFI 2.0) is safe and easy to use. In past studies, similar programs helped reduce risky drinking without causing harm. These sessions are brief, lasting about 20-30 minutes, and are conducted on a computer, involving no medication or physical procedures. So far, no negative side effects have been reported from using this type of feedback program, suggesting that AA-PFI 2.0 is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alcohol-Anxiety Personalized Feedback Intervention 2.0 (AA-PFI 2.0) because it offers a tailored approach to managing anxiety and hazardous drinking. Unlike traditional treatments that might focus on just one aspect, like medication or therapy, this intervention provides personalized feedback, potentially making it more effective for individuals by addressing their unique needs. The intervention is also brief, taking only 20-30 minutes, which could make it a more accessible and appealing option for those seeking help. Additionally, the control arm, the Control Personalized Feedback Intervention (C-PFI), serves as a comparison to evaluate the effectiveness of personalized feedback, which is a relatively new approach in this field.

What evidence suggests that this trial's interventions could be effective for anxiety and hazardous drinking?

Research has shown that the Alcohol-Anxiety Personalized Feedback Intervention 2.0 (AA-PFI 2.0), which participants in this trial may receive, can help reduce heavy drinking and anxiety. This short, computer-based program targets Latinx individuals who drink heavily and experience anxiety. Early results suggest it helps individuals understand the harmful effects of combining alcohol and anxiety, encouraging habit change. The program incorporates key elements of Latinx culture, enhancing its relatability and effectiveness for participants. Overall, AA-PFI 2.0 appears promising in facilitating positive changes in these areas. Another group in this trial will receive the Control Personalized Feedback Intervention (C-PFI), serving as an active comparator. ^{1 3 5 6 7}

Who Is on the Research Team?

Michael J Zvolensky, Ph.D.

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for Latinx individuals aged 21-75 who drink hazardously and have clinical anxiety. Participants must be fluent in Spanish, not currently pregnant, not undergoing psychotherapy for anxiety, and not involved in substance use programs.

Inclusion Criteria

You identify as Latinx or Hispanic.

I am between 21 and 75 years old.

Being able to provide written, informed consent

Exclusion Criteria

You are currently enrolled in a program for alcohol or substance use.

Currently pregnant

I am currently in therapy for anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (telephone)

Baseline

Participants complete the brief (20-30 minute) personalized feedback intervention (PFI) at baseline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in alcohol attitudes, motivation, and anxiety severity

6 months

3 visits (online)

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol-Anxiety Personalized Feedback Intervention 2.0
• Control Personalized Feedback Intervention

Trial Overview The study tests a computer-based intervention designed to educate about the risks of alcohol use with anxiety, motivate reduced drinking, and change attitudes towards using alcohol to cope with anxiety among Latinx drinkers.

How Is the Trial Designed?

Group I: Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0) Experimental Treatment 1 Intervention

Participants complete the brief (\~20-30 minute) AA-PFI 2.0 at baseline.

Group II: Control personalized feedback intervention (C-PFI) Active Control 1 Intervention

Participants complete the brief (\~20-30 minute) C-PFI at baseline.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A study involving 5476 Brazilian college students found that the components of personalized normative feedback (PNF) did not significantly reduce alcohol use or its consequences compared to the full intervention, with some evidence suggesting adverse effects, particularly among less motivated participants.

The normative feedback only (NFO) and consequences feedback only (CFO) components showed some short-term benefits in reducing alcohol use and frequency, but they also led to an increase in the number of typical drinks consumed over time, indicating a complex relationship between feedback and drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design. Bedendo, A., McCambridge, J., Gaume, J., et al.[2021]

Both personalized feedback interventions (PFIs) that included typical strategies and normative feedback were effective in correcting college students' perceptions of how often their peers engage in protective behavioral strategies (PBS) related to alcohol use.

However, neither type of PFI led to significant changes in actual PBS use, alcohol consumption, or alcohol-related consequences after one month, suggesting that while perceptions can be altered, this does not necessarily translate to behavioral change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influencing college students' normative perceptions of protective behavioral strategies: A pilot randomized trial. Leavens, ELS., Miller, MB., Brett, EI., et al.[2021]

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., et al.[2023]

Personalized feedback (PF) was found to be effective in reducing drinking among adult problem drinkers, specifically men who have sex with men, in a study involving 90 participants.

While significant reductions in drinking were observed, the study did not find specific predictors or mediators that linked participant reactions to PF with drinking outcomes, indicating a need for further research to understand how PF works in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking personalized feedback: an exploratory study of the impact of its components and the reactions it elicits among problem drinking men who have sex with men. Kuerbis, AN., Schaumberg, K., Davis, CM., et al.[2023]

The study will involve 130 college students who engage in hazardous drinking and have high anxiety sensitivity, testing a new integrated feedback intervention designed to address both issues simultaneously.

Participants will be randomly assigned to either the intervention or a control group, with follow-ups at 1 week, 1 month, and 3 months to assess the effectiveness of the intervention, marking an important step in developing integrated treatments for these co-occurring problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-delivered personalized feedback intervention for hazardous drinkers with elevated anxiety sensitivity: Study protocol for a randomized controlled trial. Paulus, DJ., Gallagher, MW., Neighbors, C., et al.[2021]

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

A randomized controlled trial involving 100 participants will evaluate a novel computer-based motivational enhancement intervention (AP-PFI) aimed at reducing hazardous drinking in individuals with subclinical PTSD and elevated anxiety sensitivity.

AP-PFI is designed to provide comprehensive feedback on alcohol use, PTSD symptoms, and anxiety sensitivity, potentially filling treatment gaps for co-occurring conditions and offering a cost-effective, evidence-based approach for healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an integrated personalized feedback intervention for hazardous drinkers with elevated anxiety sensitivity and PTSD symptoms: Protocol for a randomized controlled trial. Lebeaut, A., Pedersen, ER., Francis, DJ., et al.[2023]

A single session of a remotely-delivered personalized feedback intervention (PFI) was found to be feasible and acceptable for hazardous drinkers with elevated anxiety sensitivity, involving 125 college students.

The integrated PFI led to significant improvements in motivation, hazardous alcohol use, and anxiety sensitivity compared to a control group, suggesting it could be an effective low-cost intervention for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-delivered personalized feedback intervention for hazardous drinkers with elevated anxiety sensitivity: A pilot randomized controlled trial. Paulus, DJ., Gallagher, MW., Neighbors, C., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10850867

Latinx Hazardous Drinkers with Clinical Anxiety Phase IB activities will include a rigorous randomized clinical trial designed to compare the effectiveness of AA-PFI 2.0 to a control PFI (C-PFI) among a ...

2. withpower.com withpower.com/trial/personalized-feedback-intervention-for-anxiety-and-hazardous-drinking-ae2a4

Personalized Feedback Intervention for Anxiety and Hazardous ... What data supports the effectiveness of the treatment Alcohol-Anxiety Personalized Feedback Intervention 2.0 (AA-PFI 2.0) for anxiety and hazardous drinking?

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05246202?tab=history&a=8

Record History | ver. 8: 2022-08-09 | NCT05246202 AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.

4. clinicaltrial.be clinicaltrial.be/en/details/32544?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Personalized Feedback Intervention for Latinx Drinkers Wi... AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8119384/

Computer-Delivered Personalized Feedback Intervention ... This study aimed to evaluate the feasibility, acceptability, and initial efficacy of a single session remotely-delivered personalized feedback intervention ( ...

6. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT05246202

Anxiety & Depression Association of America Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0), Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796721000462

Computer-delivered personalized feedback intervention for ... This study aimed to evaluate the feasibility, acceptability, and initial efficacy of a single session remotely-delivered personalized feedback intervention ( ...