Massed Prolonged Exposure Therapy for PTSD and Substance Addiction

(PROJECT COMET Trial)

Overseen By Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Severe cognitive impairment, suicidal intent, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2-4 weeks

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Massed Prolonged Exposure Therapy (M-PE) to determine its effectiveness in reducing symptoms of PTSD (post-traumatic stress disorder) and decreasing substance use. The researchers compare M-PE to standard trauma treatment to assess improvements in mental health, reductions in drug or alcohol use, and dropout rates. Suitable participants have PTSD and are actively receiving help for substance use at Gateway Community Services. Participants will attend frequent therapy sessions and provide feedback on their experiences. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance future PTSD treatments.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Massed Prolonged Exposure Therapy is safe for treating PTSD and substance addiction?

Research has shown that Massed Prolonged Exposure Therapy (M-PE) is generally safe and well-tolerated for treating PTSD. Studies have found that M-PE is as effective as traditional therapy methods in reducing PTSD symptoms and does not cause more side effects. One study found that people who received M-PE experienced significant reductions in PTSD symptoms and did not drop out of treatment at high rates, suggesting that most people can handle the therapy without major issues.

When M-PE is used for people with both PTSD and a substance use disorder, it has been linked to better outcomes. This means it not only helps with PTSD but may also help reduce substance use. Overall, the evidence suggests that M-PE is a safe option for those with PTSD, even if they are also dealing with substance use challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Massed Prolonged Exposure Therapy (M-PE) is unique because it combines a gold-standard PTSD treatment with intensive substance use disorder care, aiming to tackle both issues simultaneously. Unlike traditional therapies that often address PTSD and substance use separately, M-PE is integrated into an Intensive Outpatient Program (IOP) to deliver therapy multiple times a week over a short period. This intensive approach is designed to rapidly improve PTSD symptoms and reduce substance use, offering a potentially quicker and more comprehensive path to recovery than standard treatments. Researchers are excited about M-PE because it could enhance patient outcomes by addressing the intertwined nature of trauma and addiction more effectively.

What evidence suggests that Massed Prolonged Exposure Therapy might be an effective treatment for PTSD and substance addiction?

Research has shown that Massed Prolonged Exposure Therapy (M-PE), which participants in this trial may receive, can effectively reduce PTSD symptoms. This therapy involves several sessions in a short time frame, helping to lessen PTSD symptoms and improve mental health. In this trial, one arm will evaluate the effectiveness of delivering M-PE concurrently with treatment for substance use disorders. Studies indicate that combining M-PE with such treatment often leads patients to report reduced substance use. The therapy helps individuals face and work through their traumatic memories, resulting in significant improvements in PTSD symptoms. Overall, M-PE is considered a promising method for those dealing with both PTSD and substance use issues. ^{1 4 5 6 7}

Who Is on the Research Team?

Sonya Norman Professor Of Clinical, Psychiatry, Ph.D

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults with both PTSD and substance use disorder (SUD). Participants should be currently in intensive outpatient treatment for SUD. They must be able to attend multiple therapy sessions weekly and complete various assessments over time.

Inclusion Criteria

Enrolled in SUD treatment at Gateway Community Services

Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)

Meet DSM-5 criteria for PTSD

Exclusion Criteria

Current unstable psychotic or manic symptoms not attributable to SUD

I have significant memory or thinking problems.

I do not have thoughts of harming myself or others that need immediate attention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Massed Prolonged Exposure (M-PE) therapy multiple times per week over 2-4 weeks, integrated into the Intensive Outpatient Program (IOP) for substance use disorder (SUD)

2-4 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month, 3-month, and 6-month post-treatment

6 months

Assessments at 1-month, 3-month, and 6-month

What Are the Treatments Tested in This Trial?

Interventions

• Massed Prolonged Exposure Therapy (M-PE)

Trial Overview The trial tests if Massed Prolonged Exposure Therapy (M-PE) can better reduce PTSD symptoms and substance use compared to usual trauma care. It includes frequent therapy sessions, regular assessments, and feedback collection on patient experience.

How Is the Trial Designed?

Group I: Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP) Experimental Treatment 1 Intervention

Participants randomized to this arm will receive Massed Prolonged Exposure (M-PE) therapy, a gold-standard treatment for PTSD delivered multiple times per week over 2-4 weeks. M-PE will be integrated into the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services, Inc. This arm is designed to evaluate the effectiveness of delivering M-PE concurrently with SUD treatment in improving PTSD symptoms, reducing substance use, and improving patient-centered outcomes.

Group II: Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group Active Control 1 Intervention

Participants randomized to this arm will receive the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD), which includes a weekly trauma skills group as part of usual care. This comparator arm allows for evaluation of whether M-PE enhances outcomes beyond those achieved through trauma-informed IOP care.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Citations

1. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06296186

Massed Prolonged Exposure for PTSD in Substance Use ... The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06968832

Project COMET: Massed Prolonged Exposure for PTSD ... The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9856757/

Massed vs Intensive Outpatient Prolonged Exposure for ... This randomized clinical trial assesses the efficacy of 2 prolonged exposure outpatient treatments for combat-related posttraumatic stress ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1387186/full

Massed treatment of posttraumatic stress disorder ... First launched in 2015, this paper provides a programmatic update, including new treatment components implemented since inception, and examines outcomes for all ...

5. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - National Center for PTSD For example, one study found Concurrent Treatment for PTSD and Substance Use Disorder Using Prolonged Exposure (COPE) to be more effective in reducing PTSD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10317798/

Effect of massed v. standard prolonged exposure therapy ... MPE was non-inferior to SPE in significantly reducing symptoms of PTSD. Significant reductions in symptom severity, low dropout rates, and loss of diagnosis

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.