Clinical trial NCT04007666: Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
Official title: Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Drug Abuse
Alcohol Abuse
Posttraumatic Stress Disorder
PTSD
Recidivism
Depression
Keywords: Incarcerated
Prisoners
Implementation Science
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-07-05
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that address the needs of the criminal justice system. The proposed research will be conducted as part of Dr. Zielinski's Mentored Patient-Oriented Research Career Development Award (K23), which aims to: 1) advance knowledge on implementation of a gold-standard psychotherapy for trauma, Cognitive Processing Therapy (CPT), in the prison setting and 2) examine whether prison-delivered CPT reduces drug use, psychiatric symptoms, and recidivism compared to a control condition (a coping-focused therapy). These foci have been selected because severe trauma exposure, substance use, and justice-involvement overwhelmingly co-occur in prison populations. The three specific aims in this research are: 1) Use formative evaluation to identify factors that may influence implementation and uptake of CPT in prisons, 2) Adapt CPT for incarcerated drug users and develop a facilitation-based implementation guide to support its uptake, and 3) conduct a participant-randomized Hybrid II trial to assess effectiveness and implementation outcomes of CPT with incarcerated drug users. Participants will include people who have been incarcerated (pre- and post-release from incarceration) and prison stakeholders who will be purposively sampled based on their role in implementation of CPT and other programs. Anticipated enrollment across all three Aims is 244 adult men and women.


Eligibility criteria: 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/informants participating in Aims 1-3 (additional requirements):

* All items listed in "Inclusion criteria for all participants"
* Invited by the PI to participate, due to specific role within project sites (e.g., current Warden, treatment staff member, officer, study therapist)

Inclusion criteria for prisoners completing formative evaluation interviews in Aim 1 and pre-treatment assessments in Aim 3 (additional requirements):

* All items listed in "Inclusion criteria for all participants"
* Incarcerated in either East Central Arkansas Community Correction Center (ECACCC) or Northeast Arkansas Community Correction Center (NEACCC)
* Have a pre-incarceration history of substance use disorder
* Have a history of traumatic event exposure and self-report ongoing trauma-related difficulties
* Be within 9 months of release from incarceration
* Expect to reside in Arkansas throughout the study period

Inclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):

* All items listed in "Inclusion criteria for all participants"
* All items listed in "Inclusion criteria for prisoners completing pre-treatment assessments in Aim 3"
* Evidence clinically significant PTSD symptoms during pre-treatment (baseline) assessment per the Structured Clinical Interview for the DSM
* Have a pre-incarceration history of substance use disorder (confirmed by clinical interview)

Exclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):

* Unwilling to consent to randomization
* Unable to provide locator information for post-release assessments

Primary outcomes:
measure: Post-Incarceration Drug Use
timeFrame: Approximately 3 months after release from incarceration
measure: Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration
timeFrame: Pre-treatment assessments will be completed within 4 weeks of treatment start. Post-treatment assessments will be completed within 2 weeks of treatment end. Post-release assessments will be completed approximately 3 months after release from prison.
Secondary outcomes:
measure: Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration
timeFrame: Pre-treatment assessments will be completed within 4 weeks of treatment start. Post-treatment assessments will be completed within 2 weeks of treatment end. Post-release assessments will be completed approximately 3 months after release from prison.
measure: Recidivism
timeFrame: 12 months after release from incarceration
Other outcomes:
Locations:
city: Osceola
country: United States
facility: Northeast Arkansas Community Correction Center (NEACCC)
state: Arkansas
city: West Memphis
country: United States
facility: East Central Arkansas Community Correction Center (ECACCC)
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Melissa Zielinski, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zielinski MJ, Smith MKS, Kaysen D, Selig JP, Zaller ND, Curran G, Kirchner JE. A participant-randomized pilot hybrid II trial of group cognitive processing therapy for incarcerated persons with posttraumatic stress and substance use disorder symptoms: study protocol and rationale. Health Justice. 2022 Oct 1;10(1):30. doi: 10.1186/s40352-022-00192-8.