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Brief Intervention for Alcohol Use Disorder

N/A

Recruiting

Research Sponsored by Western Kentucky University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 25

Be between 18 and 65 years old

Must not have

Currently receiving psychological therapy or psychotropic medication for substance use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to improve a mobile intervention for young adults with heavy drinking & trauma, using coping strategies & peer coaches. Results will show if it reduces alcohol use & is perceived positively.

Who is the study for?

This trial is for young adults aged 18-25 who are college students, have a history of heavy alcohol use and interpersonal trauma. They must speak English, have access to a cell phone, and not be currently receiving therapy or medication for substance use.

What is being tested?

The study tests a mobile-delivered brief intervention enhanced with coping strategies and peer support against a standard brief intervention and an assessment-only group. Participants will be randomly assigned to one of these groups and followed up at 3 and 6 months post-intervention.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, discussing trauma could potentially cause emotional discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently in therapy or taking medication for substance use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol use

Cannabis use

Cannabis-related problems

+3 more

Secondary study objectives

Alcohol use motives

Coping self-efficacy

Marijuana use motives

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)Experimental Treatment1 Intervention

In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.

Group II: Standard Brief InterventionExperimental Treatment1 Intervention

Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.

Group III: Assessment onlyExperimental Treatment1 Intervention

Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Brief Intervention

2009

Completed Phase 3

~590

Assessment only

2014

N/A

~180