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临床试验/NCT07490717
NCT07490717Enrolling By Invitation不适用

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

University of Arkansas2 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2026年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
338
试验地点
2
主要终点
A2 - Substance Use Treatment Initiation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for all participants:
  • 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
  • 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

排除标准

  • 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)

研究组 & 干预措施

Intervention Arm (Jail-Initiated PTSD Therapy)

Experimental

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.

干预措施: Cognitive Processing Therapy (CPT) (Other)

Intervention Arm (Jail-Initiated PTSD Therapy)

Experimental

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.

干预措施: Written Exposure Therapy (WET) (Other)

Control Arm (Community-Initiated PTSD Therapy)

Active Comparator

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.

干预措施: Cognitive Processing Therapy (CPT) (Other)

Control Arm (Community-Initiated PTSD Therapy)

Active Comparator

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.

干预措施: Written Exposure Therapy (WET) (Other)

结局指标

主要结局

A2 - Substance Use Treatment Initiation

时间窗: Through study completion, approximately 1 year

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

次要结局

  • A2 - Perceived Acceptability of SBIRT-J(Immediately (baseline-only))
  • A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM)(Immediately following the conclusion of Aim 2 enrollment (one-time survey))
  • A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM)(Immediately following the conclusion of Aim 2 enrollment (one-time survey))
  • A1 - SBIRT-J Reach(Immediately following the conclusion of Aim 2 enrollment)
  • A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM)(Immediately following the conclusion of Aim 2 enrollment (one-time survey))
  • A2 - Retention in Substance Use Treatment(Through study completion, approximately 1 year)
  • A2 - Opioid Use Disorder Severity(Through study completion, approximately 1 year)
  • A2 - Stimulant Use Disorder Severity(Through study completion, approximately 1 year)
  • A2 - Opioid Use(Through study completion, approximately 1 year)
  • A2 - Stimulant Use(Through study completion, approximately 1 year)
  • A2 - Overall Drug Use Frequency(Through study completion, approximately 1 year)
  • A2 - Post-Traumatic Stress Disorder (PTSD) Symptom Severity(Through study completion, approximately 1 year)
  • A2 - Drug-Related Crime(12 months post-baseline)
  • A2 - Depressive Symptoms(Immediately and until 12 months post-baseline)
  • A2 - Perceived Appropriateness of SBIRT-J(Immediately (baseline-only))
  • A2 - Perceived Appropriateness of Cognitive Processing Therapy (CPT)(Immediately (baseline-only))
  • A2 - Perceived Acceptability of Cognitive Processing Therapy (CPT)(Immediately (baseline-only))
  • A2 - Perceived Appropriateness of Written Exposure Therapy (WET)(Immediately (baseline-only))
  • A2 - Perceived Acceptability of Written Exposure Therapy (WET)(Immediately (baseline-only))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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