Behavioral Activation vs Relapse Prevention for Veterans with Alcoholism and PTSD

Overseen By Shannon M Blakey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Must not be taking: Psychotropics, Alcohol abstinence meds

Disqualifiers: Mania, Psychosis, Severe drug use, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two therapies, Behavioral Activation and Relapse Prevention, for U.S. veterans with both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The study will determine which therapy is more effective and acceptable for veterans and will explore a new method of measuring recovery using location data. Veterans who have recently experienced heavy drinking and show symptoms of PTSD might be suitable candidates for this trial. Participants will be randomly assigned to one of the therapies for eight sessions with a trained therapist. As an unphased trial, this study offers veterans a unique opportunity to contribute to innovative research that could enhance treatment options for AUD and PTSD.

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 prior data suggests that these behavioral interventions are safe for veterans with AUD/PTSD?

Research has shown that Behavioral Activation (BA) is a well-tolerated therapy. It aids individuals with depression by promoting activity and reducing avoidance. This approach can also benefit those with alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Studies suggest that BA may help treat PTSD by focusing on reducing avoidance behaviors.

Relapse Prevention now includes mindfulness techniques. This method has successfully lowered cravings and relapse rates for people with substance use disorders. While it targets substance use, it does not specifically address PTSD.

Both therapies have been used safely in the past, even if not specifically for AUD and PTSD together. Since this trial compares these two therapies, it's important to note that neither involves medication. This usually means fewer physical side effects, making them generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer targeted psychological approaches to help veterans tackle alcoholism and PTSD. Behavioral Activation (BA) is unique as it focuses on increasing engagement with positive activities to enhance mood and reduce harmful drinking behaviors, offering a proactive way to address emotional withdrawal. On the other hand, Relapse Prevention (RP) helps individuals identify and manage triggers, providing practical strategies to maintain sobriety and prevent setbacks. These methods stand out because they empower veterans with tools and techniques to directly manage their mental health challenges, potentially offering more sustainable outcomes compared to traditional medication-focused treatments like antidepressants or benzodiazepines.

What evidence suggests that this trial's treatments could be effective for veterans with AUD/PTSD?

This trial will compare Behavioral Activation (BA) with Relapse Prevention (RP) for veterans with alcoholism and PTSD. Research has shown that Behavioral Activation can reduce PTSD symptoms by encouraging participation in positive activities, which decreases avoidance behaviors often linked to alcohol use disorder (AUD) and PTSD. Participants in this trial may receive BA, specifically tailored for veterans in this context.

For those in the Relapse Prevention arm, studies have indicated it can lower the chance of returning to substance use compared to standard treatments, making it useful for managing AUD. Both BA and RP have shown promising results in helping people with PTSD and AUD. These treatments aim to support recovery by addressing the behaviors that contribute to these conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric B Elbogen, PhD

Principal Investigator

Duke University

Shannon M Blakey, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation
• Relapse Prevention

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.

How Is the Trial Designed?

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 United States, China, European Union for the following indications:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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]

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]

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) 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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39186971

Basis and methodology for a pilot randomized controlled trial This study protocol describes a 1:1 parallel, two-arm, pilot randomized controlled trial comparing Behavioral Activation (BA) psychotherapy to Relapse ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06249386?cond=co%20activation&viewType=Table&rank=7&checkSpell=

Adapting and Piloting Behavioral Activation for Veterans ... This study will advance research and practice by piloting a novel application of BA and a novel measure of AUD/PTSD recovery. This project aligns with the ...

3. researchgate.net researchgate.net/publication/383454112_Behavioral_activation_for_veterans_with_co-occurring_alcohol_use_disorder_and_posttraumatic_stress_disorder_Basis_and_methodology_for_a_pilot_randomized_controlled_trial

Behavioral activation for veterans with co-occurring alcohol ... Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot ...

4. jwatch.org jwatch.org/na49657/2019/08/05/behavioral-activation-effective-ptsd

Is Behavioral Activation Effective for PTSD? This study shows that BA, the simplest evidence-based psychotherapy for clinicians to learn and deliver, can lower PTSD symptom severity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531389/

Behavioral Activation for Veterans with Co-occurring ... Behavioral Activation (BA) could potentially fill the AUD/PTSD treatment gap. BA is a psychotherapy that decreases avoidance behaviors by increasing engagement ...

6. mentalhealth.va.gov mentalhealth.va.gov/get-help/treatment/ebt.asp

Evidence-based therapies Behavioral Activation (BA). BA is a therapy that has been shown to relieve or resolve symptoms of depression. This therapy will help you become more engaged ...