Project COMET: Massed Prolonged Exposure for PTSD and SUD

NCT06968832 | Recruiting DMC

• 2 other identifiers: Pro20240023401R01MH132720-01A1
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Posttraumatic Stress Disorder (PTSD); Substance Use Disorder (SUD); PTSD/SUD Comorbidity; Prolonged Exposure Therapy (PE); Massed Prolonged Exposure (M-PE); Randomized Clinical Trial (RCT); Treatment as Usual (TAU); Integrated PTSD and SUD Treatment; Implementation Science; Trauma-Focused Treatment

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity

  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

• Time Line Follow back (TLFB)

  Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use

  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

Secondary Outcomes (3)

• Patient Health Questionnaire-9 (PHQ-9)

  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

• Brief Psychosocial Functioning Inventory (B-IPF)

  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

• Brief Substance Craving Scale (BSCS)

  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

Study Arms (2)

Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP)

EXPERIMENTAL

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.

Behavioral: Massed Prolonged Exposure Therapy (M-PE)

Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group

ACTIVE COMPARATOR

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.

Behavioral: Standard outpatient SUD care

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.

Also known as: M-PE

Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP)

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

Also known as: Usual Care Condition

Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Enrolled in SUD treatment at Gateway Community Services
• Meet DSM-5 criteria for PTSD
• Able to give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Diego: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Gateway Community Services

Jacksonville, Florida, 32204, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Sonya Norman Professor Of Clinical, Psychiatry, Ph.D

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D

CONTACT

848-445-0749; denise.hien@smithers.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helen E. Chaney Endowed Chair in Alcohol Studies; Distinguished Professor, Graduate School of Applied and Professional Psychology

Model Details: This is a two-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to receive either (1) Massed Prolonged Exposure (M-PE) therapy integrated within Intensive Outpatient (IOP) Substance Use Disorder (SUD) treatment or (2) Treatment as Usual (TAU) in IOP SUD care, which includes a weekly trauma skills group. The goal is to evaluate the effectiveness of M-PE in improving PTSD and substance use outcomes compared to standard IOP programming.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 13, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available beginning 6 months after publication of the primary outcomes and will remain available for 5 years.
• Access Criteria: Qualified researchers affiliated with academic institutions or research organizations will be able to request access to the de-identified individual participant data (IPD) and accompanying materials, including the data dictionary and study protocol. Access will include data related to primary and secondary outcomes, as well as adverse events, once appropriate data use agreements are in place. Requests must be submitted to the study team and will be reviewed for scientific merit, ethical use, and compliance with institutional and regulatory guidelines. Approved users will be granted access through a secure data-sharing platform or via direct encrypted transfer, in accordance with Rutgers University and sponsor policies on data security and privacy.

Locations

US (1)