Co-occurring Mental and Substance Use Disorders, Medications for Opioid Use Disorder, Opioid Use Disorder (OUD), Post-traumatic Stress Disorder (PTSD), Post-traumatic Stress Symptoms, Stimulant Use & Co-occuring Opioid Use Disorders, Stimulant Use Disorder
Conditions
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, Appropriateness, Effectiveness, Evidence-Based Intervention, Individual Therapy, Stakeholders
Brief 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. 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.
Interventions
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) 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.
Sponsors
University of Arkansas
National Institute on Drug Abuse (NIDA)
Rush University Medical Center
University of New Mexico
Pulaski County Regional Detention Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A2 - Substance Use Treatment Initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM) | Immediately following the conclusion of Aim 2 enrollment (one-time survey) | 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. |
| A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM) | Immediately following the conclusion of Aim 2 enrollment (one-time survey) | 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. |
| A1 - SBIRT-J Reach | Immediately following the conclusion of Aim 2 enrollment | The ratio of people who complete SBIRT-J to the number who are booked in the PCRDF during the study period. |
| A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM) | Immediately following the conclusion of Aim 2 enrollment (one-time survey) | 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. |
| A2 - Retention in Substance Use Treatment | Through study completion, approximately 1 year | Retention in substance use treatment once initiated will be assessed via participant self-report and verified via medical chart review when possible. |
| A2 - Opioid Use Disorder Severity | Through study completion, approximately 1 year | 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). |
| A2 - Stimulant Use Disorder Severity | Through study completion, approximately 1 year | 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). |
| A2 - Opioid Use | Through study completion, approximately 1 year | 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. |
| A2 - Stimulant Use | Through study completion, approximately 1 year | 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. |
| A2 - Overall Drug Use Frequency | Through study completion, approximately 1 year | Assessed by the Timeline Follow Back Interview. Will be examined as a frequency count (number of days used in the previous 30 days). |
| A2 - Post-Traumatic Stress Disorder (PTSD) Symptom Severity | Through study completion, approximately 1 year | 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. |
| A2 - Drug-Related Crime | 12 months post-baseline | 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). |
| A2 - Depressive Symptoms | Immediately and until 12 months post-baseline | 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. |
| A2 - Perceived Appropriateness of SBIRT-J | Immediately (baseline-only) | Will be assessed with the Intervention Appropriateness Measure. |
| A2 - Perceived Acceptability of SBIRT-J | Immediately (baseline-only) | Will be assessed with the Acceptability of Intervention Measure. |
| A2 - Perceived Appropriateness of Cognitive Processing Therapy (CPT) | Immediately (baseline-only) | Will be assessed with the Intervention Appropriateness Measure. |
| A2 - Perceived Acceptability of Cognitive Processing Therapy (CPT) | Immediately (baseline-only) | Will be assessed with the Acceptability of Intervention Measure. |
| A2 - Perceived Appropriateness of Written Exposure Therapy (WET) | Immediately (baseline-only) | Will be assessed with the Intervention Appropriateness Measure. |
| A2 - Perceived Acceptability of Written Exposure Therapy (WET) | Immediately (baseline-only) | Will be assessed with the Acceptability of Intervention Measure. |
Countries
United States
Outcome results
None listed