Partner-Assisted Therapy for PTSD

(COOPERATE Trial)

Recruiting at 3 trial locations

Overseen By Emily M Hudson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Department of Defense

Disqualifiers: Imminent suicidality, Mania, Psychosis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating PTSD (Post-Traumatic Stress Disorder) in post-9/11 Veterans. It examines whether involving a partner in therapy sessions, known as Partnered Prolonged Exposure (PPE), is more effective than traditional Prolonged Exposure (PE) therapy. The goal is to improve PTSD symptoms, overall life functioning, and relationship health. Ideal participants are post-9/11 Veterans with a stable medication routine and a PTSD diagnosis, who are in a committed relationship of at least six months. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative therapy methods that could enhance treatment outcomes.

Do I need to stop my current medications to join the trial?

The trial requires that you have been on stable medication for at least one month, so you do not need to stop your current medications if they are stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Prolonged Exposure (PE) therapy is a well-known and effective treatment for PTSD, particularly in reducing symptoms for many patients, including those with combat-related PTSD. PE is considered safe and is often the first choice for treating PTSD.

Earlier studies on Partnered Prolonged Exposure (PPE) have shown promising results. This method includes significant others in the therapy process. These studies found that involving partners often leads to patients completing more of their treatment and experiencing significant improvements in PTSD symptoms and relationships. So far, PPE appears well-tolerated, with no major safety concerns reported.

For those considering joining a trial for PPE, current evidence suggests it is a safe option. Involving partners in therapy might enhance treatment benefits without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Partnered Prolonged Exposure (PPE) therapy because it brings a fresh approach to treating PTSD by actively involving a partner in the therapeutic process. Traditional PTSD treatments, like Prolonged Exposure (PE) therapy, typically focus solely on the individual. PPE stands out by integrating a partner into the therapy sessions, which can enhance support and improve treatment outcomes. This collaborative method has the potential to strengthen relationships and provide a more supportive environment, potentially leading to better and faster recovery for those affected by PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare Partnered Prolonged Exposure (PPE) therapy with traditional Prolonged Exposure (PE) therapy. Research has shown that PPE therapy can significantly improve PTSD symptoms. Studies have found that involving a partner in therapy often leads to better outcomes. Veterans who included their partners in treatment experienced more benefits. In past studies, more participants completed the treatment and saw significant improvements in PTSD symptoms and overall well-being. While traditional PE therapy is effective, PPE aims to enhance results by involving partners, potentially improving both PTSD symptoms and relationship health. ^{2 6 7 8 9}

Who Is on the Research Team?

Laura Meis, PhD

Principal Investigator

University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System

Leslie Morland, PhD

Principal Investigator

National Center for PTSD; San Diego VA Healthcare System

Are You a Good Fit for This Trial?

This trial is for post-9/11 US Service Members with PTSD. Participants should be willing to involve their partners in the treatment process. The study excludes those who may not fully benefit from partnered therapy or have conditions that could interfere with the effectiveness of the treatments being tested.

Inclusion Criteria

Committed relationship of 6+ months

I have been diagnosed with PTSD.

Post-9/11 Veteran Enrolled in VHA

Exclusion Criteria

Imminent suicidality or homicidality

Severe intimate partner violence in the last 6 months

Mania, psychosis, or severe substance use disorder in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Partnered Prolonged Exposure (PPE) or Prolonged Exposure (PE) therapy, with intimate partners attending weekly sessions

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months posttreatment

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Partnered Prolonged Exposure (PPE)
• Prolonged Exposure (PE)

Trial Overview The trial tests Partner-Assisted Prolonged Exposure (PPE) against standard Prolonged Exposure (PE) therapy for PTSD. It aims to see if involving a partner leads to better psychosocial functioning, fewer PTSD symptoms, and improved relationship health compared to individual therapy.

How Is the Trial Designed?

Group I: Partnered Prolonged Exposure (PPE) Experimental Treatment 1 Intervention

Group II: Prolonged Exposure (PE) Active Control 1 Intervention

Who Is Running the Clinical Trial?

United States Department of Defense

Lead Sponsor

Trials

940

Recruited

339,000+

Lowcountry Center for Veterans Research

Collaborator

Trials

1

Recruited

300+

Veterans Medical Research Foundation

Collaborator

Trials

46

Recruited

5,100+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

San Diego Veterans Healthcare System

Collaborator

Trials

38

Recruited

5,500+

Charleston VA Healthcare System

Collaborator

Arizona Veterans Research and Education Foundation

Collaborator

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Atlanta VA Medical Center

Collaborator

Trials

28

Recruited

69,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005874/

Cognitive–behavioural conjoint therapy versus prolonged ... This study is the first to test a couple or family therapy against a well-established, front-line recommended treatment for PTSD, with expected ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Main Outcomes and Measures The primary outcome was change in PTSD symptom severity measured with the Clinician-Administered PTSD Scale for ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/20008066.2025.2451478

Effectiveness of an intensive outpatient treatment ... Of all patients, 52 (70%) showed a clinically meaningful response, and 48 (65%) no longer met the diagnostic criteria for PTSD one month after treatment.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016503271930641X

The impact of prolonged exposure therapy on social ... Conclusions: These results suggest that increased perceived social support is a secondary outcome of exposure therapy and may be one pathway ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02556645

A Comparison of Web-Prolonged Exposure (Web-PE) and ... The second aim is to examine the efficacy of Web-PE by comparing it to therapist-delivered PCT on the following outcomes: 1) Change in PTSD severity and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160482/

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most efficacious, evidence-based treatments for posttraumatic stress disorder (PTSD).

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2800086

Massed vs Intensive Outpatient Prolonged Exposure for ... These findings suggest that both massed and intensive outpatient forms of prolonged exposure therapy are fast and effective for combat-related PTSD.

8. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1633606.pdf

Prolonged exposure therapy for the treatment of posttraumatic ... Prolonged exposure therapy (PE) is a well-established first-line treatment for posttraumatic stress disorder (PTSD) that is based on emotional ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0740547218302551

What works for whom and why: A narrative systematic ... A narrative systematic review of interventions for reducing post-traumatic stress disorder and problematic substance use among women with experiences of ...