225 Participants Needed

Brief Intervention for Alcohol Use Disorder

MW
Overseen ByMatt Woodward, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Western Kentucky University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The current proposal aims to enhance a mobile-delivered brief intervention for young adults with heavy alcohol use and interpersonal trauma by including adaptive coping strategies for managing trauma-related distress and using peer coaches after delivery of the intervention to maintain treatment gains. Individuals will be randomized to a modified brief intervention incorporating with peer coaches, a standard brief intervention, or assessment only. Participants will be followed up at 3 and 6 months post intervention. The investigators hypothesize that the trauma-informed and peer-supported brief intervention (TIPS-BI) will show low levels of dropout, will be perceived positively by participants, and will result in greater reductions in alcohol use compared to a standard brief intervention and assessment only.

Will I have to stop taking my current medications?

If you are currently taking medication for substance use, you cannot participate in this trial.

Is the Brief Intervention for Alcohol Use Disorder safe for humans?

The Seeking Safety program, which is similar to the Brief Intervention for Alcohol Use Disorder, has been used safely in various studies for people with substance use disorders and trauma-related issues. Participants generally reported positive outcomes and satisfaction with the treatment, indicating it is safe for human use.12345

How is the TIPS-BI treatment for Alcohol Use Disorder different from other treatments?

The TIPS-BI treatment is unique because it combines trauma-informed care (which considers past trauma in treatment) and peer support (help from people with similar experiences) in a brief intervention format, making it more personalized and supportive compared to standard brief interventions.678910

What data supports the effectiveness of the treatment for Alcohol Use Disorder?

Research on peer-led and trauma-informed approaches, like Seeking Safety, shows positive outcomes for people with substance use disorders and trauma-related issues, suggesting that similar methods could be effective for alcohol use disorder.211121314

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Lifetime history of interpersonal trauma exposure
Heavy alcohol use
Ability to speak and understand English
See 2 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a mobile-delivered brief intervention with personalized feedback and coping strategies

1-2 weeks
1 session (virtual)

Peer Coach Follow-up

Trained peers follow up with participants via text message to review adherence to goals and offer support

6 months
Monthly follow-ups (virtual)

Follow-up

Participants are monitored for changes in alcohol and cannabis use, coping motives, and self-efficacy

6 months
2 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Assessment only
  • Standard Brief Intervention
  • Trauma-Informed and Peer-Supported Brief Intervention
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)Experimental Treatment1 Intervention
Group II: Standard Brief InterventionExperimental Treatment1 Intervention
Group III: Assessment onlyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western Kentucky University

Lead Sponsor

Trials
12
Recruited
1,400+

Published Research Related to This Trial

A pilot study evaluated a peer-led version of the Seeking Safety (SS) program for 18 women with co-occurring substance use disorder (SUD) and trauma-related issues, showing significant improvements in trauma symptoms, mental health, and coping skills.
Participants reported high satisfaction with the peer-led SS approach, indicating its potential as an effective intervention for those facing both SUD and trauma-related challenges.
Peer-led seeking safety: results of a pilot outcome study with relevance to public health.Najavits, LM., Hamilton, N., Miller, N., et al.[2018]
This study will evaluate a new trauma-informed care model in a residential treatment service for youth aged 18-35 with substance use disorders and PTSD, focusing on staff training, service adaptations, and client support.
Outcomes will include adherence to the trauma-informed model and client treatment completion, with follow-up assessments on substance use and mental health at multiple time points over a year, aiming to improve treatment retention and outcomes for this population.
Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders.Walter, ZC., Carlyle, M., Kerswell, N., et al.[2023]
In a study involving 98 male veterans with substance use disorders and PTSD, the Seeking Safety therapy led to better drug use outcomes compared to standard treatment, indicating its effectiveness in this population.
Seeking Safety also resulted in higher treatment attendance and patient satisfaction, although the exact mechanism behind its effectiveness in reducing drug use remains unclear.
Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology.Boden, MT., Kimerling, R., Jacobs-Lentz, J., et al.[2018]

Citations

Peer-led seeking safety: results of a pilot outcome study with relevance to public health. [2018]
Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders. [2023]
Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. [2018]
Client and staff perceptions of the integration of trauma informed care and specialist posttraumatic stress disorder treatment in residential treatment facilities for substance use: A qualitative study. [2023]
Response-to-Treatment for Comorbid Post-Traumatic Stress and Substance Use Disorders: The Value of Combining Person- and Variable-Centered Approaches. [2021]
Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. [2021]
A Pilot Study of Seeking Safety in a Sample of German Women Outpatients with Substance Dependence and Posttraumatic Stress Disorder. [2015]
Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. [2022]
Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]
Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. [2023]
Brief alcohol intervention in a psychiatric outpatient setting: a randomized controlled study. [2021]
Effectiveness of brief alcohol interventions for general practice patients with problematic drinking behavior and comorbid anxiety or depressive disorders. [2008]
The Effect of Brief Interventions for Alcohol Among People with Comorbid Mental Health Conditions: A Systematic Review of Randomized Trials and Narrative Synthesis. [2022]
Brief motivational intervention at a clinic visit reduces cocaine and heroin use. [2022]
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