Behavioral Activation vs Relapse Prevention for Veterans with Alcoholism and PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Eric B Elbogen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: RTI International

Must not be taking: Psychotropics, Alcohol abstinence meds

Disqualifiers: Mania, Psychosis, Severe drug use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The primary aims of this study are to: 1. Adapt Behavioral Activation to treat veterans with AUD/PTSD, 2. Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and 3. Explore geospatial analysis as a new method for measuring AUD/PTSD recovery. Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.

Will I have to stop taking my current medications?

The trial requires that you do not change your psychotropic medications (including those for alcohol abstinence) within 90 days before starting the study or during the study itself.

What data supports the effectiveness of the treatment Behavioral Activation, Behavioral Activation Therapy, BA, Relapse Prevention, Mindfulness-Based Relapse Prevention, MBRP for Veterans with Alcoholism and PTSD?

Research shows that Mindfulness-Based Relapse Prevention (MBRP) can help people with substance use disorders by reducing cravings and increasing awareness, which may help prevent relapse. This suggests that MBRP could be beneficial for Veterans with alcoholism and PTSD by helping them manage their emotions and behaviors. ^{1 2 3 4 5}

Is Mindfulness-Based Relapse Prevention (MBRP) safe for humans?

Mindfulness-Based Relapse Prevention (MBRP) has been used safely in studies with veterans and women with substance use disorders and PTSD. While high dropout rates were noted, no specific safety concerns were reported, suggesting it is generally safe for human use. ^{1 3 5 6 7}

How is the treatment Behavioral Activation vs Relapse Prevention unique for veterans with alcoholism and PTSD?

This treatment is unique because it combines Behavioral Activation, which focuses on increasing engagement in positive activities to improve mood, with Mindfulness-Based Relapse Prevention (MBRP), which integrates mindfulness meditation and cognitive-behavioral strategies to help veterans manage emotional triggers and prevent relapse. ^{1 3 6 7 8}

Research Team

Shannon M Blakey, PhD

Principal Investigator

RTI International

Eric B Elbogen, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for U.S. military veterans who are dealing with both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Participants should be willing to undergo interviews, self-report measures, and geospatial assessments before and after the treatment.

Inclusion Criteria

Have served in the U.S. military

Meet DSM-5 criteria for current AUD

Report 3+ heavy drinking days (5+ drinks for men/4+ drinks for women) and 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days

Exclusion Criteria

A score of 10+ on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)

Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder (which is not exclusionary) or past-30-day heroin or non-prescription opioid use

I have never had mania or hypomania, and I am not currently experiencing psychosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in psychosocial functioning, alcohol use, anxiety, PTSD severity, and geospatial activity

4 weeks

Treatment Details

Interventions

• Behavioral Activation (Behavioral Intervention)
• Relapse Prevention (Behavioral Intervention)

Trial Overview The study compares two treatments: Behavioral Activation (BA), adapted specifically for veterans with AUD/PTSD, against Relapse Prevention (RP). Each participant receives 8 sessions of one treatment type, decided randomly.

Participant Groups

Group I: Behavioral Activation (BA) Experimental Treatment 1 Intervention

Individual psychotherapy

Group II: Relapse Prevention (RP) Active Control 1 Intervention

Individual psychotherapy

Behavioral Activation is already approved in China for the following indications:

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

Dr. Anuja Purohit

RTI International

Chief Medical Officer

MD from Duke University School of Medicine

Tim J. Gabel

RTI International

Chief Executive Officer since 2022

Adjunct appointments at University of Wyoming and UNC Gillings School of Global Public Health

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

The study is a two-site, randomized controlled trial comparing Mindfulness-Based Relapse Prevention (MBRP) to 12-Step Facilitation (TSF) in military Veterans who have completed intensive outpatient treatment for substance use disorders, with an 8-week intervention followed by long-term follow-ups.

The primary goal is to determine if MBRP is more effective than TSF in preventing relapse and improving recovery outcomes, including quality of life and mental health, in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. Brady, KT., Killeen, T., Baker, NL.[2021]

An eight-week mindfulness-based relapse prevention (MBRP) program was tested on 20 cannabis users, but preliminary results showed no significant difference in the number of joints smoked compared to those receiving standard treatment.

Despite the lack of significant quantitative results, many participants in the MBRP group reported positive qualitative changes in their cannabis consumption, suggesting that mindfulness may still play a beneficial role in managing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. Schneegans, A., Bourgognon, F., Albuisson, E., et al.[2022]

Mindfulness-based relapse prevention (MBRP) and cognitive-behavioral relapse prevention (RP) significantly reduced the risk of relapse to substance use and heavy drinking compared to treatment as usual (TAU) during a 12-month follow-up with 286 participants.

At the 12-month mark, MBRP participants reported fewer days of substance use and heavy drinking compared to both RP and TAU, suggesting that mindfulness practices can enhance long-term recovery outcomes by helping individuals manage cravings and negative emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. Bowen, S., Witkiewitz, K., Clifasefi, SL., et al.[2022]

The study involved 168 adults with substance use disorders and evaluated an 8-week Mindfulness-Based Relapse Prevention (MBRP) program, showing it was feasible with high participant satisfaction and good homework compliance.

Participants in the MBRP program had significantly lower rates of substance use and greater improvements in craving management and mindfulness skills compared to those receiving standard treatment as usual (TAU) over a 4-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Bowen, S., Chawla, N., Collins, SE., et al.[2022]

Mindfulness-based relapse prevention (MBRP) is more effective than relapse prevention (RP) for reducing drug use days, especially in therapy groups where at least one-third of the participants are women, based on a study of 186 individuals with substance use disorders.

The analysis found that while individual gender did not affect treatment outcomes, the gender composition of the group significantly influenced the efficacy of MBRP, leading to complete abstinence from drugs for all participants in mixed-gender groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual gender and group gender composition as predictors of differential benefit from mindfulness-based relapse prevention for substance use disorders. Roos, C., Stein, E., Bowen, S., et al.[2022]

The study assessed the feasibility and acceptability of trauma-integrated mindfulness-based relapse prevention (TI-MBRP) for women with comorbid PTSD and substance use disorder (SUD), involving 83 participants.

While TI-MBRP was found to be acceptable, it had a high attrition rate of 64% at 12 months, and the standard mindfulness-based relapse prevention (MBRP) showed greater reductions in PTSD symptoms compared to TI-MBRP at post-course and 1-month follow-up, indicating that MBRP alone may effectively address both PTSD and SUD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Integrated Mindfulness-Based Relapse Prevention for Women with Comorbid Post-Traumatic Stress Disorder and Substance Use Disorder: A Cluster Randomized Controlled Feasibility and Acceptability Trial. Somohano, VC., Bowen, S.[2022]

Comorbid PTSD and substance use disorders (SUD) often lead to worse clinical outcomes, but integrated treatment approaches can effectively address both conditions simultaneously.

The study introduces a modified Mindfulness-based Relapse Prevention (MBRP) program tailored for women with PTSD and SUD, aiming to enhance coping skills and reduce relapse rates through a randomized controlled pilot trial in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design, and implementation of a clinical trial of a mindfulness-based relapse prevention protocol for the treatment of women with comorbid post traumatic stress disorder and substance use disorder. Vrana, C., Killeen, T., Brant, V., et al.[2018]

In a study of 62 male veterans with alcohol use disorder, valproate did not significantly reduce relapse rates to heavy drinking compared to naltrexone, indicating that both treatments may have similar efficacy in this population.

Veterans with a history of moderate to severe traumatic brain injury were found to be significantly more likely to relapse to heavy drinking, suggesting that TBI may be a critical factor influencing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Alcohol Use Disorder in U.S. Veterans: The Role of Traumatic Brain Injury. Jorge, RE., Li, R., Liu, X., et al.[2022]

References

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

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. [2022]

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

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. [2022]

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

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. [2022]

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

Individual gender and group gender composition as predictors of differential benefit from mindfulness-based relapse prevention for substance use disorders. [2022]

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

Trauma-Integrated Mindfulness-Based Relapse Prevention for Women with Comorbid Post-Traumatic Stress Disorder and Substance Use Disorder: A Cluster Randomized Controlled Feasibility and Acceptability Trial. [2022]

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

Rationale, design, and implementation of a clinical trial of a mindfulness-based relapse prevention protocol for the treatment of women with comorbid post traumatic stress disorder and substance use disorder. [2018]

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

Treating Alcohol Use Disorder in U.S. Veterans: The Role of Traumatic Brain Injury. [2022]