Couples Treatment for Co-occurring Disorders

(PACT-V Trial)

Overseen By Sarah T Giff, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: VA Office of Research and Development

Must be taking: Psychotropic medications

Disqualifiers: Violence, Psychotic, Bipolar, Suicidal, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new couples therapy approach, called COPE + BFIT, designed to help Veterans with both PTSD (post-traumatic stress disorder) and AUD (alcohol use disorder). Veterans will receive individual therapy, and they and their significant others will attend joint sessions to assess improvements in treatment outcomes. The trial targets Veterans who have lived with their partner for at least six months and are dealing with both PTSD and a primary alcohol issue. Participants must not currently be in couple therapy and should be stable on any mental health medications. This trial is an early step to determine if involving loved ones can enhance PTSD and AUD treatments for Veterans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

Participants taking psychotropic medications need to be on a stable dose for at least 4 weeks before starting the study, so you won't have to stop them, but you need to maintain the same dose.

What prior data suggests that this couples intervention is safe for Veterans with PTSD and AUD?

Studies have shown that treatments like COPE (Concurrent Treatment of PTSD and Substance Use Disorders with Prolonged Exposure) and B-FIT (Brief Family Involved Treatment) are designed to help individuals with both PTSD and alcohol use disorder. Although specific safety data for using COPE and B-FIT together is not available, these therapies typically involve talking and family support, which are generally manageable for participants.

As this study is in the early stages (Early Phase 1), the primary goal is to assess the treatment's safety and patient tolerance. While detailed information may be limited, the absence of medication or surgery suggests a likely safety. Participants will receive support from loved ones and professionals throughout the process, aiding in managing any challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPE + BFIT treatment for co-occurring disorders because it offers a unique, integrated approach that combines cognitive-behavioral therapy with physical fitness. Unlike typical treatments that focus solely on mental health through medication or talk therapy, this method also incorporates exercise, which can enhance mood and cognitive function. By addressing both the mind and body, COPE + BFIT has the potential to offer a more holistic improvement for individuals dealing with co-occurring disorders. This dual-focus strategy could lead to better engagement and outcomes for patients compared to traditional treatments.

What evidence suggests that this treatment might be an effective treatment for PTSD and AUD?

Research has shown that combining treatments can aid individuals with both mental health and substance use issues. This approach has improved outcomes for those facing these challenges. For Veterans with PTSD and alcohol use disorder, involving family and friends may enhance these benefits, as support is crucial for recovery. In this trial, participants will receive a combination of COPE and BFIT, designed to leverage this support for better outcomes. Although specific data on COPE and BFIT together is limited, similar treatments have generally shown promise for individuals with both conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Sarah T Giff, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD and alcohol use disorder who are in a romantic relationship. They should be willing to participate in treatment sessions with their partners. There's no specific exclusion criteria provided, but typically those with severe medical conditions or conflicting treatments might not qualify.

Inclusion Criteria

I have been on a stable dose of my mental health medication for at least 4 weeks.

The Veteran meets current or past-year DSM-5 diagnostic status for both PTSD (assessed via CAPS-5) and AUD (assessed via the Quick Structured Clinical Interview for DSM-5). Concurrent substance use disorders are acceptable provided that alcohol is the Veteran's primary substance of choice

I can understand and make decisions about my treatment (scored ≥26 on MMSE).

Exclusion Criteria

History of moderate, severe, or unilateral violence in the relationship in the past year as measured by the CTS-2

Either partner reports current suicidal or homicidal ideation and intent or prior intent or attempt in the past 6 months as assessed by the CSSRS and PHQ-9 item 9

The Veteran's SO cannot have substance use problems as indicated by a score < 8 on the AUDIT and QuickSCID

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans receive individual treatment through COPE and attend 3-4 sessions of B-FIT with their romantic partners

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• COPE + BFIT

Trial Overview

The study tests a combination of individual therapy called COPE and couples therapy named BFIT over 12 weeks. The goal is to see if involving partners can help improve the treatment outcomes for Veterans dealing with both PTSD and AUD.

How Is the Trial Designed?

Group I: COPE + BFIT Experimental Treatment 1 Intervention

In this single arm study, participants will be assigned only to the pilot intervention of COPE + B-FIT.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10157410/

Integrated vs non-integrated treatment outcomes in dual ...

However, no significant benefits were found between integrated and non-integrated treatment regarding substance misuse and treatment retention. Conclusion.

2.

library.samhsa.gov

library.samhsa.gov/sites/default/files/ebp-kit-building-your-program-10112019.pdf

Integrated Treatment for Co-Occurring Disorders

The evidence from these studies shows that this model is effective at improving both co-occurring disorders and housing outcomes. Presumably, the outreach ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3974008/

The effectiveness of integrated treatment in patients ... - PMC

Integrated Treatment (IT) has proved effective in treating patients with Substance Use Disorders (SUD) co-occurring with severe Mental Disorders (MD), ...

4.

psyclarityhealth.com

psyclarityhealth.com/the-importance-of-integrated-treatment-for-dual-diagnosis-and-addiction/

The Importance of Integrated Treatment for Dual Diagnosis ...

Integrated treatment is crucial for individuals with dual diagnosis and addiction as it leads to better outcomes and quality of life.

5.

recoveryanswers.org

recoveryanswers.org/research-post/chronic-care-management-improves-treatment-utilization-but-not-outcomes-for-individuals-with-co-occurring-disorders/

Co-occurring disorders lead to worse treatment outcomes

People with co-occurring mental health & substance use disorders tend to experience worse treatment outcomes than individuals with one or the other.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2200799/

Co-Occurring Disorders in Substance Abuse Treatment - PMC

Overall, 6.6% of individuals with co-occurring disorders not involving serious mental disorders reported receiving both substance abuse and mental health ...

7.

samhsa.gov

samhsa.gov/mental-health/serious-mental-illness/co-occurring-disorders

Managing Life with Co-Occurring Disorders

SAMHSA offers evidence-based resources to help providers screen, diagnose, and deliver integrated care to patients with co-occurring disorders.

8.

tac.org

tac.org/reports_publications/dual-diagnosis-serious-mental-illness-and-co-occurring-substance-use-disorders/

Dual Diagnosis: Serious Mental Illness and Co-Occurring ...

Only 12.7% of people with co-occurring serious mental illness and substance use disorders received any treatment for both conditions in 2019. People with ...

9.

pew.org

pew.org/en/research-and-analysis/issue-briefs/2023/02/over-1-in-9-people-with-co-occurring-mental-illness-and-substance-use-disorders-arrested-annually

More Than 1 in 9 Adults With Co-Occurring Mental Illness ...

More than 1 in 9 adults with co-occurring disorders were arrested annually, 12 times more often than adults with neither a substance use disorder nor a mental ...