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

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

Trial Summary

What is the purpose of this trial?

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 receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are: * Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)? * Does M-PE reduce the number of days participants use substances? * How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU? * Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates. Participants will: * Attend multiple therapy sessions per week (M-PE) or receive usual care * Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up * Share feedback through surveys and interviews about their experience in the program

Research Team

Sonya Norman Professor Of Clinical, Psychiatry, Ph.D

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+