Clinical trial NCT06968832: Project COMET: Massed Prolonged Exposure for PTSD and SUD
Official title: Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Diego
name: University of Minnesota
First posted: 2025-05-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: 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
measure: Time Line Follow back (TLFB)
timeFrame: 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:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 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
measure: Brief Psychosocial Functioning Inventory (B-IPF)
timeFrame: 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
measure: Brief Substance Craving Scale (BSCS)
timeFrame: 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
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
Study officials:
affiliation: University of California, San Diego
name: Sonya Norman Professor Of Clinical, Psychiatry, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: