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Project COMET: Massed Prolonged Exposure for PTSD and SUD
NCT06968832 · Rutgers, The State University of New Jersey
In plain English
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Official title
Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program
About this study
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
Study design
Enrollment target: 168 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-09-02
Estimated completion: 2029-06-30
Last updated: 2025-10-27
Interventions
Behavioral: Massed Prolonged Exposure Therapy (M-PE)Behavioral: Standard outpatient SUD care
Primary outcomes
- • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (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) (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)
Sponsor
Rutgers, The State University of New Jersey · other
With: National Institute of Mental Health (NIMH), University of California, San Diego, University of Minnesota
Contacts & investigators
ContactDenise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D · contact · denise.hien@smithers.rutgers.edu · 848-445-0749
InvestigatorSonya Norman Professor Of Clinical, Psychiatry, Ph.D · principal_investigator, University of California, San Diego
All locations (1)
Gateway Community ServicesRecruiting
Jacksonville, Florida, United States