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

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

Inclusion Criteria5

  • 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

Exclusion Criteria3

  • severe cognitive impairment
  • current suicidal or homicidal intent requiring immediate treatment
  • current unstable psychotic or manic symptoms not attributable to SUD

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


Locations(1)

Gateway Community Services

Jacksonville, Florida, United States

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NCT06968832


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