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Post-traumatic Stress Disorder (PTSD)HOPENCT07490717

Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails

A study testing Cognitive Processing Therapy (CPT) and Written Exposure Therapy (WET) in people with Post-traumatic Stress Disorder (PTSD) and Post-traumatic Stress Symptoms, run by University of Arkansas at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Processing Therapy (CPT) and Written Exposure Therapy (WET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
2 sitesUnited States
Study dates
20 Jan 2026to 31 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Able to understand and speak English
  • Able to give informed consent
  • Inclusion criteria for key stakeholders participating in Aim 1 (additional requirements):
  • All items listed in "Inclusion criteria for all participants"
  • Invited by the PI to participate, due to specific role within the project site
Show all 15Show fewer
  • Inclusion criteria for people incarcerated at the study site completing assessments in Aim 2 (additional requirements):
  • All items listed in "Inclusion criteria for all participants"
  • Incarcerated at the study site
  • Screened positive for probable PTSD and OUD/STUD as part of the SBIRT-J process
  • Have an expected duration of incarceration that is compatible with receiving trauma-focused treatment and completing assessments within the remaining timeline of the study
  • Exclusion criteria for people incarcerated at the study site to enroll in the Hybrid trial in Aim 2 (additional requirements):
  • Unwilling to consent to randomization
  • Unable to provide locator information for post-release assessments
  • Currently experiencing psychiatric symptoms that would preclude participation in CPT or WET (e.g., severe behavioral dysregulation, severe psychotic symptoms)

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Pulaski County Regional Detention Facility

    Little Rock, Arkansas, 72204

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

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.

Being tested
Cognitive Processing Therapy (CPT), Written Exposure Therapy (WET)
Keywords
Post-Traumatic Stress Disorder, Trauma, Substance Use Disorders, Opioid Use Disorder, Stimulant Use Disorder, SBIRT, Screening, Brief Intervention, Referral to Treatment, Trauma-Focused Therapy, Cognitive Processing Therapy, Cognitive Processing Therapy for Criminal Justice Setting, Written Exposure Therapy, Criminal Justice, Incarceration, Detention, Jail, Implementation, Implementation Evaluation, Acceptability
Medical subject headings
Stress Disorders, Post-Traumatic, Opioid-Related Disorders, Substance-Related Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Processing Therapy (CPT)Other

    Cognitive Processing Therapy (CPT) is an evidence-based therapy for PTSD that helps people understand how trauma has impacted their life and learn balanced ways to think about the trauma. Participants who choose to pursue CPT will complete worksheets and talk about them with a counselor. CPT will be offered individually; in-person, televideo, and/or phone visits will be acceptable. CPT

  • Written Exposure Therapy (WET)Other

    Written Exposure Therapy (WET) is an evidence-based therapy for PTSD that helps people face memories of trauma so they become less upsetting over time, which can helps people feel more in control of their emotions and reactions. Participants who choose to pursue WET will write about the traumatic event and then talk with a counselor. WET will be offered individually; in-person, televideo, and/or phone visits will be acceptable.

Study groups in NCT07490717
Study groupRoleWhat they receive
Intervention Arm (Jail-Initiated PTSD Therapy)ExperimentalFollowing 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.
Receives: Other: Cognitive Processing Therapy (CPT); Other: Written Exposure Therapy (WET)
Control Arm (Community-Initiated PTSD Therapy)Active comparatorFollowing 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.
Receives: Other: Cognitive Processing Therapy (CPT); Other: Written Exposure Therapy (WET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A2 - Substance Use Treatment Initiation

    Substance use treatment initiation (binary; presence vs absence) will be assessed via participant self-report and verified via medical chart review when possible.

    Measured: Through study completion, approximately 1 year

Secondary outcomes (19)
  1. A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM)

    The extent to which SBIRT-J is perceived as satisfactory by stakeholders. Mean scores on the AIM range from 1-5, with higher scores indicating greater intervention acceptability.

    Measured: Immediately following the conclusion of Aim 2 enrollment (one-time survey)

  2. A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM)

    The extent to which SBIRT-J is perceived by stakeholders as relevant to and compatible with the setting and population. Mean scores on the IAM range from 1-5, with higher scores indicating greater intervention appropriateness.

    Measured: Immediately following the conclusion of Aim 2 enrollment (one-time survey)

  3. A1 - SBIRT-J Reach

    The ratio of people who complete SBIRT-J to the number who are booked in the PCRDF during the study period.

    Measured: Immediately following the conclusion of Aim 2 enrollment

  4. A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM)

    The extent to which SBIRT-J is perceived by jail stakeholders as useable. Mean scores on the FIM range from 1-5, with higher scores indicating greater intervention feasibility.

    Measured: Immediately following the conclusion of Aim 2 enrollment (one-time survey)

  5. A2 - Retention in Substance Use Treatment

    Retention in substance use treatment once initiated will be assessed via participant self-report and verified via medical chart review when possible.

    Measured: Through study completion, approximately 1 year

  6. A2 - Opioid Use Disorder Severity

    Opioid use disorder (OUD) severity will be assessed via a DSM-5 checklist of OUD diagnostic criteria; this checklist has a maximum score of 11, with higher scores indicating more severe symptoms and scores of ≥2 indicating symptoms likely to meet criteria for OUD. Scores will be examined as both dichotomous (presence vs. absence) and continuous (total number of symptoms).

    Measured: Through study completion, approximately 1 year

  7. A2 - Stimulant Use Disorder Severity

    Stimulant use disorder (STUD) severity will be assessed via a DSM-5 checklist of STUD diagnostic criteria; this checklist has a maximum score of 11, with higher scores indicating more severe symptoms and scores of ≥2 indicating symptoms likely to meet criteria for STUD. Scores will be examined as both dichotomous (presence vs. absence) and continuous (total number of symptoms).

    Measured: Through study completion, approximately 1 year

  8. A2 - Opioid Use

    Opioid use will be assessed via participant self-report on the 30-Day Timeline Follow Back Interview and will be examined as both a binary variable and a frequency count representing number of days of use.

    Measured: Through study completion, approximately 1 year

  9. A2 - Stimulant Use

    Stimulant use will be assessed via participant self-report on the 30-Day Timeline Follow Back Interview. The total number of days of stimulant use will be calculated and examined as a frequency count.

    Measured: Through study completion, approximately 1 year

  10. A2 - Overall Drug Use Frequency

    Assessed by the Timeline Follow Back Interview. Will be examined as a frequency count (number of days used in the previous 30 days).

    Measured: Through study completion, approximately 1 year

  11. A2 - Post-Traumatic Stress Disorder (PTSD) Symptom Severity

    Per the PTSD Checklist for DSM-5. Will be a continuous score of 0-80, where lower scores indicate lower PTSD symptoms and thus a better treatment outcome.

    Measured: Through study completion, approximately 1 year

  12. A2 - Drug-Related Crime

    Assessed via the Criminal and Legal Activities Form. Will primarily be defined as 1) new arrests for drug charges and 2) new convictions for drug charges and will be examined as both a binary variable (presence or absence of any drug-related crime) and frequency counts (number of new drug charges or convictions).

    Measured: 12 months post-baseline

  13. A2 - Depressive Symptoms

    Assessed via the Patient Health Questionnaire-8. Depressive symptoms will be a continuous score of 0-24 where lower scores indicate lower symptom levels and thus a better treatment outcome.

    Measured: Immediately and until 12 months post-baseline

  14. A2 - Perceived Appropriateness of SBIRT-J

    Will be assessed with the Intervention Appropriateness Measure.

    Measured: Immediately (baseline-only)

  15. A2 - Perceived Acceptability of SBIRT-J

    Will be assessed with the Acceptability of Intervention Measure.

    Measured: Immediately (baseline-only)

  16. A2 - Perceived Appropriateness of Cognitive Processing Therapy (CPT)

    Will be assessed with the Intervention Appropriateness Measure.

    Measured: Immediately (baseline-only)

  17. A2 - Perceived Acceptability of Cognitive Processing Therapy (CPT)

    Will be assessed with the Acceptability of Intervention Measure.

    Measured: Immediately (baseline-only)

  18. A2 - Perceived Appropriateness of Written Exposure Therapy (WET)

    Will be assessed with the Intervention Appropriateness Measure.

    Measured: Immediately (baseline-only)

  19. A2 - Perceived Acceptability of Written Exposure Therapy (WET)

    Will be assessed with the Acceptability of Intervention Measure.

    Measured: Immediately (baseline-only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2026
  2. Study start20 Jan 2026
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
338 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490717
Sponsor's protocol ID
298680
Other IDs
4R33DA059947
Acronym
HOPE
Status last verified
Feb 2026
First submitted
5 Mar 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Information in the research records will be released to requesters, in compliance with NIH's requirements for data sharing. Final research data for this project will also be made as available as possible while safeguarding the privacy of participants and protecting all confidential and proprietary data. This will include depositing data into a shared repository.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Processing Therapy (CPT) and Written Exposure Therapy (WET) in people with Post-traumatic Stress Disorder (PTSD) and Post-traumatic Stress Symptoms, run by University of Arkansas at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A2 - Substance Use Treatment Initiation (time frame: Through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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