Acceptance and Commitment Therapy for PTSD and Alcohol Use Disorder

(ACT-SHARE Trial)

Overseen By Hannah Grigorian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychosis, Mania, Suicidality, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called ACT-SHARE (Acceptance and Commitment Therapy), designed to help veterans with PTSD and alcohol misuse improve their romantic relationships, particularly in cases of conflict or unhealthy dynamics. The therapy focuses on managing difficult emotions and promoting positive actions to enhance relationship health. Veterans who have experienced intimate partner violence in the last three months and wish to address their relationship issues may find this trial suitable. As an unphased trial, it offers veterans a unique opportunity to explore innovative therapy tailored to their specific relationship challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for veterans with PTSD and alcohol misuse?

Research has shown that Acceptance and Commitment Therapy (ACT) has been tested for individuals with PTSD (post-traumatic stress disorder) and alcohol use problems. In a small study with 43 veterans, ACT led to a clear reduction in PTSD symptoms and alcohol use, suggesting it might be safe and helpful for those with similar challenges.

Three detailed reviews have also found that ACT improves treatment outcomes for substance use issues, indicating it could be safe and effective. While these studies suggest ACT is generally well-tolerated, consulting a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for PTSD and alcohol use disorder, which often include medication and traditional talk therapy, ACT-SHARE stands out because it uses Acceptance and Commitment Therapy (ACT) with a focus on social health, achievement, and relationship effectiveness. This approach helps individuals not only manage symptoms but also improve their overall social functioning and interpersonal relationships. Researchers are excited about ACT-SHARE because it specifically addresses the interconnected nature of PTSD, alcohol use, and social challenges, potentially offering a more holistic and integrated form of therapy.

What evidence suggests that ACT-SHARE might be an effective treatment for PTSD and alcohol misuse?

Research has shown that Acceptance and Commitment Therapy (ACT) can greatly reduce symptoms of PTSD and problems with alcohol use. One study with 43 veterans demonstrated clear improvements in both PTSD symptoms and alcohol misuse through ACT. This therapy helps individuals manage difficult emotions and encourages positive actions, which can also enhance relationships. Additionally, reviews of multiple studies have found that ACT positively affects substance use problems. This trial will evaluate ACT-SHARE, a version of ACT, which could be beneficial for veterans facing these challenges. ^{3 4 6 7 8}

Who Is on the Research Team?

Hannah Grigorian, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

This trial is for Veterans over 18 with PTSD and alcohol misuse who have experienced intimate partner violence (IPV) recently. They should want to improve their romantic relationships, be able to give informed consent, and agree to audio recordings. It's not for those needing inpatient care for suicidality, detoxification from severe substance use, or those with cognitive impairments or active psychosis/mania.

Inclusion Criteria

Endorses at least one act of IPV in the past 3 months

Consents to partner outreach if in a relationship

I am over 18 years old.

Exclusion Criteria

I do not have any cognitive issues that would prevent me from participating in the study.

Severity of active substance use requiring detoxification

Evidence of active psychosis or mania

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and refinement of the ACT-SHARE intervention through iterative feedback

Varies

Treatment

Participants receive the ACT-SHARE intervention, which includes Acceptance and Commitment Therapy tailored for social health, achievement, and relationship effectiveness

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in relationship functioning, IPV use, PTSD symptoms, and alcohol use

12 months

3-month and 6-month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• ACT-SHARE

Trial Overview The trial tests ACT-SHARE therapy designed to help Veterans manage PTSD and alcohol misuse while improving relationship health. The therapy aims at handling internal challenges like reactivity and cravings while promoting actions that enhance intimate relationships.

How Is the Trial Designed?

Group I: ACT-SHARE Experimental Treatment 1 Intervention

This is a single-arm intervention with all participants assigned to receive Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE). ACT-SHARE has been adapted for this study from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a pilot study involving 43 veterans with PTSD and alcohol use disorder, Acceptance and Commitment Therapy (ACT) led to significant reductions in PTSD symptoms and alcohol-related issues, with 67% of participants completing the treatment protocol.

Improvements in quality of life and reductions in depressive symptoms were also observed, suggesting that ACT is a promising treatment option for individuals with co-occurring PTSD and AUD, particularly when mindfulness practices are emphasized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Co-Occurring Posttraumatic Stress Disorder and Alcohol Use Disorders in Veterans: Pilot Treatment Outcomes. Meyer, EC., Walser, R., Hermann, B., et al.[2019]

Integrated cognitive behaviour therapy (CBT) for PTSD and alcohol use disorders (AUD) showed that participants receiving exposure therapy had a significantly higher rate of clinically meaningful improvement in PTSD severity compared to those receiving standard alcohol-support therapy (60% vs 39%).

While both therapies reduced PTSD severity, participants in the alcohol-support group reported greater reductions in alcohol consumption and dependence, suggesting that tailored approaches may be necessary for optimal outcomes in individuals with coexisting PTSD and AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. Sannibale, C., Teesson, M., Creamer, M., et al.[2019]

Acceptance and Commitment Therapy (ACT) can help improve treatment engagement for veterans with PTSD by addressing avoidance behaviors that often hinder participation in traditional therapies.

ACT techniques, such as cognitive defusion and values clarification, have shown promise in enhancing engagement with cognitive-behavioral treatments, suggesting they could be beneficial as adjuncts to standard PTSD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using acceptance and commitment therapy techniques to enhance treatment engagement in veterans with posttraumatic stress disorder. Phillips, MA., Chase, T., Bautista, C., et al.[2021]

Acceptance and Commitment Therapy (ACT) significantly improved cumulative abstinence duration and reduced depression and anxiety symptoms in patients with alcohol use disorder (AUD) and comorbid affective disorders compared to treatment as usual (TAU) alone, based on a study of 52 participants.

The benefits of ACT were sustained over a 6-month follow-up period, indicating its effectiveness as an adjunct to standard treatment for enhancing recovery outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy in the Treatment of Alcohol Use Disorder and Comorbid Affective Disorder: A Pilot Matched Control Trial. Thekiso, TB., Murphy, P., Milnes, J., et al.[2018]

A multi-site randomized clinical trial is currently evaluating Acceptance and Commitment Therapy (ACT) as a treatment for trauma-related mental health issues in military personnel, addressing the need for effective therapies for veterans with high comorbidity.

ACT is considered a promising transdiagnostic treatment approach, which means it can be beneficial for multiple mental health diagnoses, making it potentially more efficient for veterans readjusting after service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating transdiagnostic treatment for distress and impairment in veterans: a multi-site randomized controlled trial of Acceptance and Commitment Therapy. Lang, AJ., Schnurr, PP., Jain, S., et al.[2013]

A pilot study involving 109 participants tested a brief text message intervention based on cognitive behavioral therapy (CBT) and message framing, showing high feasibility and acceptability for individuals with co-occurring PTSD and alcohol misuse.

The CBT + Framing intervention demonstrated significant reductions in PTSD symptoms and heavy drinking episodes compared to a supportive control group, although results varied across different waves of the study, indicating the need for further research on effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. Bedard-Gilligan, MA., Dworkin, ER., Kaysen, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06746727

Study Details | NCT06746727 | The Development of a ... This is a single-arm intervention with all participants assigned to receive Acceptance and Commitment Therapy for Social Health, Achievement, ...

2. withpower.com withpower.com/trial/acceptance-and-commitment-therapy-for-ptsd-and-alcohol-use-disorder-254a2

Acceptance and Commitment Therapy for PTSD and ... In a pilot study involving 43 veterans with PTSD and alcohol use disorder, Acceptance and Commitment Therapy (ACT) led to significant reductions in PTSD ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12249220/

The Role of Acceptance and Commitment Therapy in ... ACT offers a holistic approach that enhances social connections and personal growth. It helps individuals shift from a cycle of avoidance and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221214472400053X

Effectiveness of acceptance and commitment therapy for ... Three previous systematic reviews have concluded that ACT has a positive effect on treatment outcomes for substance use disorders. Specifically, ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06746727

Clinical Trials Registry - ICH GCP This is a single-arm intervention with all participants assigned to receive Acceptance and Commitment Therapy for Social Health, Achievement, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30338561/

Acceptance and Commitment Therapy for Co-Occurring ... Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) frequently co-occur and are associated with worse outcomes together than ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00760994

Reducing Alcohol Use & Post-traumatic Stress Disorder ... The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post- ...

8. mdpi.com mdpi.com/2077-0383/11/12/3482

A Randomized Pilot Study of Acceptance and Commitment ... This study is a pilot randomized trial of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS).