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 intensiveoutpatient (IOP) treatment for substance use disorder (SUD). The main questions it aimsto 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
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.
Behavioral: 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.
Other Name: M-PE
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
Other Name: Usual Care Condition
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
Gateway Community Services
Jacksonville, Florida, United States
Investigator: Candy Hodgkins CEO - Gateway Comunity Services, Inc., Doctor of Philosophy (Ph.D.)
Contact: 1-877-389-9966
chodgkins@gwjax.com
Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D
848-445-0749
denise.hien@smithers.rutgers.edu
Sonya Norman Professor Of Clinical, Psychiatry, Ph.D, Principal Investigator
University of California, San Diego