Project COMET: Massed Prolonged Exposure for PTSD and SUD

NCT ID: NCT06968832

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-02
• Study Completion Date: 2029-06-30

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

Detailed Description

Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly).

M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in outpatient care. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M-PE delivery in of SUD IOP program in improving PTSD and other mental health outcomes is the necessary next step in this critical research.

The mixed-method two-group Hybrid Type I effectiveness-implementation randomized clinical trial (RCT) aims to determine the effectiveness of M-PE delivery in SUD IOP in reducing dropout rates and improving outcomes as compared to trauma treatment as usual (TAU).

The specific aims are to 1) Compare the effectiveness of M-PE to trauma TAU in IOP SUD treatment in impacting PTSD symptoms and Percent days use of primary substance; 2) Explore differences in treatment arms on patient-centered outcomes, including: a) days use of other (non-primary) substances, b) depressive symptoms, c) functioning, c) quality of life (QoL), e) suicidal ideation, and f) participant satisfaction; 3) Examine gender as a moderator and changes in trauma-related cognitions, cravings, and their temporal association as mediators of change in PTSD and substance use; and 4) Conduct a mixed-method process evaluation to understand patients', providers', and clinical stakeholders' experiences with M-PE, explore barriers and facilitators to integrating M-PE into IOP SUD treatment, and identify strategies for widespread implementation.

Participants will include 168 male and female patients with any trauma type who are participating in IOP SUD program at Gateway Community Services, Inc. Assessments will occur at baseline, and will continue for the duration of treatment, at end-of-treatment, 1-month posttreatment, 3-months posttreatment, and 6-months posttreatment. We will conduct a mixed-method, multi-stakeholder process evaluation with patients, providers, and clinical leaders.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Massed Prolonged Exposure Therapy (M-PE)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard outpatient SUD care

Intervention Type: 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

Interventions

Massed 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.

Intervention Type: BEHAVIORAL

Standard 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

Intervention Type: BEHAVIORAL

Other Intervention Names

M-PE; Usual Care Condition

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Denise Aimee Hien

Helen E. Chaney Endowed Chair in Alcohol Studies; Distinguished Professor, Graduate School of Applied and Professional Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonya Norman Professor Of Clinical, Psychiatry, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Gateway Community Services

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

denise.hien@smithers.rutgers.edu

848-445-0749

Facility Contacts

Candy Hodgkins CEO - Gateway Comunity Services, Inc., Doctor of Philosophy (Ph.D.)

Role: primary

chodgkins@gwjax.com

1-877-389-9966

Other Identifiers

1R01MH132720-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2024002340

Identifier Type: -

Identifier Source: org_study_id