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

Обзор

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.

Вмешательства

• Другое Cognitive Processing Therapy (CPT)
  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
• Другое Written Exposure Therapy (WET)
  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.

Первичные конечные точки

• A2 - Substance Use Treatment Initiation [Срок оценки: Through study completion, approximately 1 year]

Вторичные конечные точки (12)

• A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM) [Срок оценки: Immediately following the conclusion of Aim 2 enrollment (one-time survey)]
• A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM) [Срок оценки: Immediately following the conclusion of Aim 2 enrollment (one-time survey)]
• A1 - SBIRT-J Reach [Срок оценки: Immediately following the conclusion of Aim 2 enrollment]
• A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM) [Срок оценки: Immediately following the conclusion of Aim 2 enrollment (one-time survey)]
• A2 - Retention in Substance Use Treatment [Срок оценки: Through study completion, approximately 1 year]
• A2 - Opioid Use Disorder Severity [Срок оценки: Through study completion, approximately 1 year]
• A2 - Stimulant Use Disorder Severity [Срок оценки: Through study completion, approximately 1 year]
• A2 - Opioid Use [Срок оценки: Through study completion, approximately 1 year]
• A2 - Stimulant Use [Срок оценки: Through study completion, approximately 1 year]
• A2 - Overall Drug Use Frequency [Срок оценки: Through study completion, approximately 1 year]
• A2 - Post-Traumatic Stress Disorder (PTSD) Symptom Severity [Срок оценки: Through study completion, approximately 1 year]
• A2 - Drug-Related Crime [Срок оценки: 12 months post-baseline]

Критерии участия

Inclusion criteria 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

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Pulaski County Regional Detention Facility — Little Rock
• University of Arkansas for Medical Sciences — Little Rock

Идентификаторы

NCT: NCT07490717 · 298680 · 4R33DA059947

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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