Trauma-Focused Therapies for PTSD
(HOPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Opioid overdose is the leading cause of death among people recently released from incarceration. Recent evidence also shows a rise in stimulant use among justice-involved populations, as well as growing rates of concurrent opioid and stimulant use. Yet, while there is growing research on opioid use disorder (OUD), stimulant use disorder (STUD), and substance use treatment in jails and prisons, studies find that few people who are referred to community substance use treatment actually initiate treatment after release. But, emerging research suggests that therapy for posttraumatic stress disorder (PTSD), a common and deleterious OUD and STUD comorbidity, could profoundly increase the likelihood of engagement with substance use treatment; however, this has not been tested in jails, and acceptable, appropriate, and feasible ways to identify and link people with probable PTSD and OUD/STUD in this setting to treatment are required to be able to examine this possibility. Therefore, this 4-year R33 aims to 1) describe engagement in and examine the implementation outcomes of an innovative approach to identifying and referring people with probable PTSD and OUD/STUD to needed treatment services and 2) the effectiveness and implementation outcomes of two competing models of subsequent trauma-focused therapy initiation timing (i.e., immediate initiation of therapy vs initiation upon community reentry) among people who demonstrate need for OUD/STUD services and who accept referral. To address Aim 1, the investigators will assess the implementation context for and subsequently implement a screening, brief intervention, and referral to treatment model that was adapted to identify and address the substance use and mental health needs of adults with probable PTSD and OUD/STUD in the jail setting (SBIRT-J) in the Pulaski County Regional Detention Facility; the investigators will describe engagement in and examine the implementation outcomes of the SBIRT-J model via a summative evaluation guided by the Consolidated Framework for Implementation Research. Specifically, there will be a survey and interview jail stakeholders (e.g., jail leadership, officers) to understand perceptions of the acceptability, appropriateness, and feasibility of the SBIRT-J model as well as SBIRT-J implementation determinants (i.e., barriers and facilitators), and use administrative data to understand the degree to which SBIRT-J is adopted during active enrollment in the R33 Aim 2 research trial and sustained in the 6 months after enrollment end. Fidelity to the SBIRT-J model will also be monitored and reported. To address Aim 2, the investigators will conduct a patient-randomized Hybrid type I implementation-effectiveness trial in which adults who are identified as having probable PTSD and OUD/STUD through the SBIRT-J model and who consent to participate in the trial are randomly assigned to either immediate initiation of therapy for PTSD in jail or initiation of PTSD therapy upon release. The primary effectiveness outcome will be post-release substance use treatment initiation by 6-months post-release from jail; secondary and exploratory outcomes will include substance use treatment readiness and retention, OUD/STUD severity, PTSD symptoms, victimization, overdose, and additional drug use. Participants in the effectiveness portion of the trial (N = 338; \~50% female) will be enrolled from the largest jail in Arkansas. Jail stakeholders will also be enrolled to provide implementation-related data. The overall goal is to translate research to practice to increase the provision of high-quality care for justice-involved persons with probable PTSD and OUD/STUD. Indeed, this study will be the first trial of a treatment for PTSD in jails as a method for improving OUD/STUD outcomes, providing foundational information on PTSD as a novel intervention target for meeting the needs of a particularly vulnerable population and providing the implementation data to inform rapid scale-up, if effective.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
SBIRT-J Implementation
Implementation of the SBIRT-J model to identify and address substance use and mental health needs in jail
Treatment
Participants receive PTSD therapy either in jail or upon community reentry
Follow-up
Participants are monitored for substance use treatment initiation and retention post-release
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Processing Therapy (CPT)
- Written Exposure Therapy (WET)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Following participation in SBIRT-J, individuals who screen positive for both PTSD and OUD/STUD will be invited to participate in the trial. Participants who are randomized to this condition will be referred to begin PTSD therapy as soon as possible, while still in jail. The delivery schedule can be variable to meet participants' needs and preferences. PTSD therapy will be continued post-release if a participant in this condition is released from jail prior to completion (i.e., in cases of earlier-than-expected release) as well as continued if the participant returns to jail while treatment remains ongoing.
Following participation in SBIRT-J, individuals who screen positive for both PTSD and OUD/STUD will be invited to participate in the trial. Participants who are randomized to this condition will be scheduled to begin PTSD Therapy in the community upon release from jail. The delivery schedule for each community-initiated PTSD Therapy can also be variable to meet participants' needs and preferences. This arm is considered the control arm because it is the arm most consistent with usual care in the jail setting (although a somewhat enhanced usual care condition because direct referral to PTSD Therapy is not made or paid for as standard practice-referral to mental health treatment, more generally, is what would be more typical). As in the Jail-Initiated arm, treatment will continue if the participant returns to jail while treatment remains ongoing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Rush University Medical Center
Collaborator
University of New Mexico
Collaborator
Pulaski County Regional Detention Center
Collaborator
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