About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
severe cognitive impairment
current suicidal or homicidal intent requiring immediate treatment
current unstable psychotic or manic symptoms not attributable to SUD
Trial design
Parallel
Treatments tested in this trial
Massed Prolonged Exposure Therapy (M-PE)
BehavioralMassed 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
BehavioralPatients randomized to usual care will receive standard intensive outpatient SUD treatment. * Resilience group (weekly) * Peer support * Individual therapy from a variety of modalities
Treatment groups
Trial outcomes
Primary outcomes
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
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
Secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Brief Psychosocial Functioning Inventory (B-IPF)
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Brief Substance Craving Scale (BSCS)
Assesses craving severity for a primary and, if applicable, secondary substance over the past 24 hours. Includes items on intensity, frequency, duration, and number of craving episodes. Higher scores reflect greater craving.
Sponsors and contacts
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Rutgers, The State University of New Jersey
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of California, San Diego
Collaborator
University of Minnesota
Collaborator