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

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Veterans seeking to improve their romantic relationships when high conflict and unhealthy dynamics (e.g., aggression) are present remain underserved within the VHA with few treatment options. Veterans with PTSD and alcohol misuse face compounding and overlapping barriers to intimate relationship functioning warranting tailored interventions. These Veterans may be best served through individual, Acceptance and Commitment Therapy (ACT) interventions which can both 1) improve the ability to manage challenging, internal experiences (e.g., physiological reactivity, cravings, beliefs about worth and trust) and 2) encourage participation in valued actions to improve relationship functioning. Following development and refinement, this clinical trial will pilot an evidence-based, integrated ACT intervention (ACT for Social Health, Achievement, and Relationship Effectiveness \[ACT-SHARE\]) to improve relationship health and safety for Veterans with PTSD alcohol misuse.

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.

Is Acceptance and Commitment Therapy (ACT) safe for treating PTSD and Alcohol Use Disorder?

ACT has been studied in various conditions, including PTSD and alcohol use disorder, and is generally considered safe. In studies, participants have shown improvements in symptoms and quality of life, with high retention rates, indicating that people tend to stick with the treatment without major safety concerns. ^{1 2 3 4 5}

How does the treatment ACT-SHARE differ from other treatments for PTSD and Alcohol Use Disorder?

ACT-SHARE is unique because it combines mindfulness and acceptance strategies to help patients with PTSD and Alcohol Use Disorder, focusing on reducing avoidance and increasing psychological flexibility. Unlike traditional therapies, it emphasizes values-based behavior and frequent mindfulness practice, which may lead to sustained improvements in symptoms and quality of life. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment ACT-SHARE for PTSD and Alcohol Use Disorder?

Research shows that Acceptance and Commitment Therapy (ACT) can help reduce PTSD symptoms and alcohol use in veterans, with improvements in quality of life and fewer depressive symptoms. ACT has also been shown to enhance treatment outcomes for alcohol use disorder when combined with usual care, leading to better drinking and mental health outcomes. ^{1 3 8 9 10}

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

I am over 18 years old.

Consents to partner outreach if in a relationship

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]

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 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]

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]

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]

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]

Citations

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

Acceptance and Commitment Therapy for Co-Occurring Posttraumatic Stress Disorder and Alcohol Use Disorders in Veterans: Pilot Treatment Outcomes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A controlled examination of two coping skills for daily alcohol use and PTSD symptom severity among dually diagnosed individuals. [2018]

3. England 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. [2018]

4. Netherlands 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Posttraumatic stress and substance use among military veterans: Associations with distress intolerance and anxiety sensitivity. [2022]

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

Using acceptance and commitment therapy techniques to enhance treatment engagement in veterans with posttraumatic stress disorder. [2021]

7. United States 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. [2013]

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

Acceptance and commitment therapy in the treatment of anxiety: a systematic review. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019]

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

Efficacy of Integrated Exposure Therapy vs Integrated Coping Skills Therapy for Comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A Randomized Clinical Trial. [2021]