Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18+

• 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

• Able to give informed consent

Locations
United States
Florida
Gateway Community Services
RECRUITING
Jacksonville
Contact Information
Primary
Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D
denise.hien@smithers.rutgers.edu
848-445-0749
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 168
Treatments
Experimental: Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP)
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.
Active_comparator: Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, National Institute of Mental Health (NIMH), University of Minnesota
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov