RecruitingNot ApplicableNCT06968832

Project COMET: Massed Prolonged Exposure for PTSD and SUD

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

Sponsor

Rutgers, The State University of New Jersey

Enrollment

168 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Posttraumatic Stress Disorder (PTSD)Trauma and Stressor Related Disorders Substance Use Disorders (SUD)Comorbidity

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called Project COMET — is testing whether an intensive, time-concentrated version of a trauma therapy called Prolonged Exposure (PE) can effectively treat both PTSD and substance use disorder (SUD) at the same time in people already enrolled in addiction treatment. **You may be eligible if...** - You are 18 or older - You are currently enrolled in substance use disorder (SUD) treatment at Gateway Community Services - You meet diagnostic criteria for both a SUD and PTSD - You are able to give informed consent **You may NOT be eligible if...** - You have severe cognitive impairment that would prevent you from participating in therapy - You are currently in active psychosis or have severe, unstable psychiatric symptoms - Your only substance issue is tobacco use disorder - You are at imminent risk of self-harm or suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMassed Prolonged Exposure Therapy (M-PE)

Massed Prolonged Exposure (M-PE) is a trauma-focused, evidence-based behavioral intervention for posttraumatic stress disorder (PTSD). It is delivered over a compressed timeline (e.g., 10 sessions over 2-4 weeks) as opposed to weekly sessions over 3-4 months. This format has been shown to accelerate PTSD symptom reduction and reduce treatment dropout. In this study, M-PE will be delivered concurrently with an Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services. Sessions will be led by trained clinicians using a standardized PE protocol, with treatment including imaginal exposure, in vivo exposure, and processing.

BEHAVIORALStandard outpatient SUD care

Patients randomized to usual care will receive standard intensive outpatient SUD treatment. * Resilience group (weekly) * Peer support * Individual therapy from a variety of modalities