Project COMET: Massed Prolonged Exposure for PTSD and SUD

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Massed Prolonged Exposure Therapy (M-PE) — BEHAVIORAL
  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.
• Standard outpatient SUD care — BEHAVIORAL
  Patients randomized to usual care will receive standard intensive outpatient SUD treatment. * Resilience group (weekly) * Peer support * Individual therapy from a variety of modalities

Study Details

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

Key Dates

Start date

Sep 2, 2025

Status verified

Oct 2025

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

168 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up ]

Central Contacts

• Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D
  848-445-0749
  [email protected]

Locations (1)

Find similar trials in Jacksonville, FL

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