Brief Intervention for Alcohol Use Disorder

Overseen By Matt Woodward, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Western Kentucky University

Must not be taking: Psychotropic medication

Disqualifiers: Psychological therapy, others

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

Compensation: Varies

Number of Visits: 3

225 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

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

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?

Group I: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI) Experimental Treatment 1 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 Intervention Experimental Treatment 1 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 only Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Clients and staff in residential treatment facilities perceive PTSD as a significant underlying cause of substance use disorders (SUD), with many using substances to cope with PTSD symptoms.

There is a strong desire for integrated trauma-informed care (TIC) and PTSD treatment within residential settings, as both clients and staff believe this approach can enhance treatment outcomes for those with comorbid SUD and PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mefodeva, V., Carlyle, M., Walter, Z., et al.[2023]

The study utilized parallel process latent class growth analysis (PP-LCGA) in two clinical trials involving 140 participants to identify distinct response trajectories for PTSD symptoms and substance use, highlighting the complexity of treating co-occurring PTSD and substance use disorder (PTSD+SUD).

Results indicated that treatment responses could be categorized into specific profiles for both PTSD and substance use, revealing that some individuals are treatment responders while others are non-responders, and that analyzing these outcomes together provides a more comprehensive understanding of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response-to-Treatment for Comorbid Post-Traumatic Stress and Substance Use Disorders: The Value of Combining Person- and Variable-Centered Approaches. Allan, NP., López-Castro, T., Hien, DA., et al.[2021]

The study aims to evaluate the efficacy of the Seeking Safety program, an integrated treatment for PTSD and substance use disorder (SUD), in a Dutch outpatient population through a randomized controlled trial involving 12 group sessions.

It is expected that participants receiving Seeking Safety will show greater improvements in substance use severity and lower drop-out rates compared to those receiving Cognitive Behavioral Therapy (CBT), with assessments conducted at the start, end, and six months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. Kok, T., de Haan, HA., van der Meer, M., et al.[2021]

In a study of 53 female outpatients with substance use disorder (SUD) and posttraumatic stress disorder (PTSD), those who attended at least six sessions of the Seeking Safety therapy showed medium to large improvements in PTSD symptoms and general mental health by the end of treatment, with these benefits maintained at a three-month follow-up.

While significant improvements in alcohol use were only observed at follow-up, the findings suggest that Seeking Safety can be an effective integrated therapy for women dealing with both SUD and PTSD, despite the study's limitations such as the absence of a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Seeking Safety in a Sample of German Women Outpatients with Substance Dependence and Posttraumatic Stress Disorder. Kaiser, D., Grundmann, J., Schulze, C., et al.[2015]

A pilot study involving 18 veterans showed that the Seeking Safety treatment, a cognitive-behavioral approach for those with both substance use disorders and PTSD, led to significant symptom reduction after 14 months of clinician training.

The treatment was well-received by clinicians, indicating its acceptability in a VA setting, although there are challenges to making it a standard part of routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. Cook, JM., Walser, RD., Kane, V., et al.[2022]

In a study of 110 veterans undergoing treatment for comorbid PTSD and alcohol use disorder, increased alcohol consumption during therapy was linked to a significantly higher risk of dropping out, particularly in those receiving integrated exposure therapy.

Specifically, for each additional drink consumed per day, the risk of dropout increased fivefold, highlighting the importance of monitoring alcohol use as a potential marker for patient retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. Kline, AC., Panza, KE., Harlé, KM., et al.[2023]

A study involving 739 Michigan Army National Guard members found that both web-based and peer-based brief interventions significantly reduced binge drinking episodes compared to enhanced usual care after 12 months.

The peer-based intervention was particularly effective, showing a greater reduction in binge drinking (-0.43) compared to the web-based intervention (-0.34), indicating that personal support may enhance the effectiveness of alcohol use interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. Blow, FC., Walton, M., Ilgen, M., et al.[2023]

In a study involving 150 psychiatric outpatients with hazardous or harmful drinking, both minimal intervention and brief alcohol intervention (BI) led to a small reduction in AUDIT scores after 12 months, indicating some effectiveness in reducing alcohol use.

Despite the small improvements, there were no significant differences between the two intervention groups, suggesting that while brief interventions can be beneficial, more intensive treatment options may be necessary for better outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief alcohol intervention in a psychiatric outpatient setting: a randomized controlled study. Nehlin, C., Grönbladh, L., Fredriksson, A., et al.[2021]

In a study of 408 patients with alcohol use disorders, brief interventions (BIs) significantly reduced drinking in those without comorbid depression or anxiety, but not in those with these comorbidities.

Interestingly, individuals with comorbid conditions showed a greater overall reduction in drinking compared to non-comorbid participants, suggesting that while BIs were less effective for them, their baseline drinking levels may have influenced the outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of brief alcohol interventions for general practice patients with problematic drinking behavior and comorbid anxiety or depressive disorders. Grothues, JM., Bischof, G., Reinhardt, S., et al.[2008]

A systematic review of 17 randomized controlled trials found that brief interventions (BIs) for alcohol can significantly reduce consumption in adults with risky drinking and comorbid mental health issues, particularly in 4 out of 9 studies for common mental disorders and 2 out of 5 for severe mental illness.

The effectiveness of BIs varied widely depending on factors like the delivery method, intensity, and study design, indicating that more rigorous research is needed to clarify their impact on alcohol consumption in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Brief Interventions for Alcohol Among People with Comorbid Mental Health Conditions: A Systematic Review of Randomized Trials and Narrative Synthesis. Boniface, S., Malet-Lambert, I., Coleman, R., et al.[2022]

A randomized controlled trial involving 1,175 out-of-treatment cocaine and heroin users showed that a single structured intervention significantly increased drug abstinence rates compared to a control group, with 22.3% of cocaine users and 40.2% of heroin users achieving abstinence.

The intervention group also demonstrated a substantial reduction in drug levels, with cocaine levels decreasing by 29% compared to only 4% in the control group, indicating the intervention's efficacy in promoting drug cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief motivational intervention at a clinic visit reduces cocaine and heroin use. Bernstein, J., Bernstein, E., Tassiopoulos, K., et al.[2022]

Citations

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

Peer-led seeking safety: results of a pilot outcome study with relevance to public health. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

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]

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

Response-to-Treatment for Comorbid Post-Traumatic Stress and Substance Use Disorders: The Value of Combining Person- and Variable-Centered Approaches. [2021]

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

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. [2021]

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

A Pilot Study of Seeking Safety in a Sample of German Women Outpatients with Substance Dependence and Posttraumatic Stress Disorder. [2015]

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

Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Brief alcohol intervention in a psychiatric outpatient setting: a randomized controlled study. [2021]

12. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of brief alcohol interventions for general practice patients with problematic drinking behavior and comorbid anxiety or depressive disorders. [2008]

13. England pubmed.ncbi.nlm.nih.gov

The Effect of Brief Interventions for Alcohol Among People with Comorbid Mental Health Conditions: A Systematic Review of Randomized Trials and Narrative Synthesis. [2022]

14. Ireland pubmed.ncbi.nlm.nih.gov

Brief motivational intervention at a clinic visit reduces cocaine and heroin use. [2022]