Telehealth Alcohol Intervention for Alcohol Consumption

(Tele-BASICS Trial)

Overseen By Eric R Pedersen, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Not meeting inclusion criteria, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the BASICS treatment for alcohol consumption?

Research shows that telehealth interventions, like the one used in the BASICS treatment, can effectively reduce alcohol use. For example, a study found that telehealth programs for alcohol use disorder led to significant reductions in blood alcohol concentration over 90 days, suggesting that such approaches can help people drink less. ^{1 2 3 4 5}

Is the telehealth alcohol intervention safe for humans?

The studies reviewed focus on digital and technology-delivered interventions for alcohol use, which are generally considered safe for humans. These interventions, like smartphone apps and web-based programs, offer a convenient and accessible way to address alcohol use without significant safety concerns reported. ^{6 7 8 9 10}

How does the BASICS telehealth treatment for alcohol consumption differ from other treatments?

The BASICS telehealth treatment is unique because it offers a brief alcohol intervention specifically designed for college students, delivered via videoconferencing, which increases accessibility and maintains effectiveness similar to face-to-face sessions. This approach also enhances therapeutic alliance, which is linked to greater reductions in alcohol use and related harm. ^{1 2 5 11 12}

What is the purpose of this trial?

This research study will test the efficacy of a telehealth version of the Brief Alcohol Screening and Intervention for College Students (BASICS), which is the gold standard prevention and intervention approach to target heavy alcohol use on college campuses across the United States.

Research Team

Eric R Pedersen, Ph.D.

Principal Investigator

University of Southern California

Clayton Neighbors, Ph.D.

Principal Investigator

University of Houston

Eligibility Criteria

This trial is for college students who engage in heavy alcohol use. Specific eligibility details are not provided, but typically participants must be of legal drinking age and enrolled in a participating college.

Inclusion Criteria

A registered student at one of the two intervention sites

Access to a webcam, which is a standard feature of most laptops, mobile devices, and desktops

Experienced at least one negative alcohol-related consequence in the previous month (mandated students would meet this due to receiving an alcohol sanction)

Exclusion Criteria

I do not meet the study requirements or do not want to join.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person BASICS, Tele-BASICS, or treatment as usual intervention

1-2 weeks

1 session (in-person or virtual)

Follow-up

Participants are monitored for alcohol-related consequences and alcohol use

12 months

Assessments at 1, 3, 6, and 12 months post-baseline

Treatment Details

Interventions

• BASICS

Trial Overview The study is testing the effectiveness of an online version of BASICS (Brief Alcohol Screening and Intervention for College Students) delivered through telehealth to reduce heavy alcohol consumption among college students.

Participant Groups

Group I: Tele-BASICS Experimental Treatment 1 Intervention

This intervention conditions consist of a feedback interview with a trained facilitator just like in the in-person BASICS condition. However, the feedback interview will be conducted over Zoom. Trained facilitators will meet individually with the students using video conferencing software and provide concrete personalized feedback regarding the following BASICS content: drinking patterns, drinking norms, risks, beliefs about alcohol and its effects, and protective behavioral strategies

Group II: In-person BASICS Experimental Treatment 1 Intervention

This intervention conditions consist of a feedback interview with a trained facilitator. The feedback interview is a one-hour intervention based on the information provided during the baseline assessment. The content and process of the interview will be similar to methods developed and tested by Marlatt and colleagues and described in detail in the BASICS manual. Trained facilitators will meet individually with the students in-person and provide concrete personalized feedback regarding the following BASICS content: drinking patterns, drinking norms, risks, beliefs about alcohol and its effects, and protective behavioral strategies

Group III: Treatment as usual Active Control 1 Intervention

The control group for this study will receive the universities' online program that is typically given to students as a first line sanction. The program is informed by BASICS, but includes no facilitator, either in-person or online. It is primarily text-based with some graphics. It contains alcohol information (physiological reactions at specific blood alcohol levels, safe drinking tips, signs of alcohol poisoning), descriptions of alcohol laws and policies (on campus, minor in possession laws), campus and national resources (e.g., contact information for crisis hotlines and student counseling center), and personalized feedback (e.g., number of calories consumed via alcoholic drinks, money spent on alcohol).

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

Telemedicine, specifically through videoconferencing, is being used to effectively deliver motivational enhancement therapy to at-risk alcohol users in rural areas, where access to treatment is often limited.

This approach not only addresses the lack of evidence-based substance abuse treatment in rural communities but also tailors interventions to the specific needs of at-risk groups, enhancing the potential for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. Staton-Tindall, M., Wahler, E., Webster, JM., et al.[2021]

In a study of 4121 patients receiving alcohol use disorder treatment via telehealth, 50.1% retained treatment for 90 days, indicating a significant level of engagement with the program.

Patients showed a substantial reduction in daily estimated peak blood alcohol concentration (BAC), decreasing from a mean of 0.092 on day 1 to 0.038 by day 90, demonstrating the efficacy of telehealth in promoting drinking reductions across various patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment retention and reductions in blood alcohol concentration (BAC) during the first 90 days of a telehealth program for alcohol use disorder. Hallgren, KA., Galloway, GP., Witkiewitz, K., et al.[2023]

A smartphone application designed to help reduce unhealthy alcohol use was found to be acceptable and useful among 130 adults, with significant reductions in weekly drinking (from 15.0 to 10.9 drinks/week) and binge drinking (from 95.4% to 64.3%) after 3 months.

Participants who used the application more than once reported a 30% reduction in weekly alcohol consumption, indicating that increased engagement with the app may lead to better drinking outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. Bertholet, N., Daeppen, JB., McNeely, J., et al.[2022]

The interactive, video-enhanced e-SBI (electronic screening and brief intervention) was found to be highly acceptable among pregnant women, with participants rating it as easy to use and helpful, scoring between 4.7 to 5.0 on a 5-point scale.

The pilot trial suggested medium-sized effects of the e-SBI on achieving 90-day period prevalence abstinence from alcohol and improved pregnancy outcomes, with odds ratios of 3.4 and 3.3 respectively, indicating potential benefits that warrant further investigation in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. Ondersma, SJ., Beatty, JR., Svikis, DS., et al.[2018]

The telehealth in-home-messaging-device was developed to enhance access to treatment for patients with substance use disorders, addressing barriers like transportation and treatment availability in rural areas.

A pilot study with six outpatient veterans showed that the Substance Use Disorder telehealth management program was well-received, being considered acceptable, easy to use, and helpful in managing their substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an in-home telehealth program for outpatient veterans with substance use disorders. Santa Ana, EJ., Stallings, DL., Rounsaville, BJ., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a pharmacist-delivered primary care telemedicine intervention to increase access to pharmacotherapy and specialty treatment for alcohol use problems: Protocol for the alcohol telemedicine consult cluster-randomized pragmatic trial. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of enhanced telephone monitoring with detoxification patients: 3- and 6-month outcomes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Treatment retention and reductions in blood alcohol concentration (BAC) during the first 90 days of a telehealth program for alcohol use disorder. [2023]

6. England pubmed.ncbi.nlm.nih.gov

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Comparing counselling models for the hazardous use of alcohol at the Swedish National Alcohol Helpline: study protocol for a randomised controlled trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. [2018]

10. India pubmed.ncbi.nlm.nih.gov

A review of web based interventions focusing on alcohol use. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Development of an in-home telehealth program for outpatient veterans with substance use disorders. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A comparison between telehealth and face-to-face delivery of a brief alcohol intervention for college students. [2022]