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Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users

Primary Purpose

Substance Use Disorders, Drug Abuse, Alcohol Abuse

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Control Group
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Incarcerated, Prisoners, Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northeast Arkansas Community Correction Center (NEACCC)
  • East Central Arkansas Community Correction Center (ECACCC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Processing Therapy (CPT)

Coping Skills Group

Arm Description

CPT is a gold-standard evidence-based psychotherapy for PTSD that combines education about trauma with strategies to challenge the trauma-related cognitions that are theorized to maintain PTSD symptoms. It can be delivered in group and individual formats, but will be delivered in a group format in this project due to feasibility in the setting. Structure will be based on feedback obtained during completion of Aim 2 while remaining within the range evaluated in prior research (i.e., 8-12 sessions, 1-2x per week, each lasting 1.5-2 hours).

The Coping Skills Group will match for attention and dose, without adding any cost to the system. Exact content will be determined during completion of Aim 2; however, project sites already provide coping-focused programming and coping-skill approaches to trauma treatment are a common alternative to evidence-based therapies for PTSD, such as CPT, that deal more directly with the index trauma. To provide an enhanced standard of care, the investigator will review treatment materials (workbooks, handouts) already used in prison settings and arrange a curriculum of skills similar to those in coping-focused trauma-informed interventions (e.g., psychoeducation, assertiveness).

Outcomes

Primary Outcome Measures

Post-Incarceration Drug Use
Drug use will be examined as both binary responses (abstinence vs. any use) and frequency counts (number of days of use). These variables will be derived from information gained via Timeline Follow-Back Interview.
Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration
PTSD symptoms will be assessed using the 20-item PTSD Checklist (PCL-5). Response options are used to indicate the severity of each PTSD symptom and range from 0 (not at all) to 4 (extremely). Total scores range from 0-80. Lower scores indicate lower levels of PTSD symptoms and therefore a better treatment outcome.

Secondary Outcome Measures

Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration
Depression symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Response options are using to indicate the severity of each symptom of depression and range from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Lower scores indicate lower levels of depression symptoms and therefore a better treatment outcome.
Recidivism
Recidivism will be extracted from administrative incarceration records and examined as both a binary variable (presence or absence of any drug-related recidivism) and frequency counts (number of new drug charges).

Full Information

First Posted
June 24, 2019
Last Updated
January 8, 2023
Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04007666
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Drug Abuse, Alcohol Abuse, Posttraumatic Stress Disorder, PTSD, Recidivism, Depression
Keywords
Incarcerated, Prisoners, Implementation Science

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy (CPT)
Arm Type
Experimental
Arm Description
CPT is a gold-standard evidence-based psychotherapy for PTSD that combines education about trauma with strategies to challenge the trauma-related cognitions that are theorized to maintain PTSD symptoms. It can be delivered in group and individual formats, but will be delivered in a group format in this project due to feasibility in the setting. Structure will be based on feedback obtained during completion of Aim 2 while remaining within the range evaluated in prior research (i.e., 8-12 sessions, 1-2x per week, each lasting 1.5-2 hours).
Arm Title
Coping Skills Group
Arm Type
Active Comparator
Arm Description
The Coping Skills Group will match for attention and dose, without adding any cost to the system. Exact content will be determined during completion of Aim 2; however, project sites already provide coping-focused programming and coping-skill approaches to trauma treatment are a common alternative to evidence-based therapies for PTSD, such as CPT, that deal more directly with the index trauma. To provide an enhanced standard of care, the investigator will review treatment materials (workbooks, handouts) already used in prison settings and arrange a curriculum of skills similar to those in coping-focused trauma-informed interventions (e.g., psychoeducation, assertiveness).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD that combines education about trauma with strategies to challenge the trauma-related cognitions that are theorized to maintain PTSD symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Coping-focused treatment drawn from material already offered in selected facilities.
Primary Outcome Measure Information:
Title
Post-Incarceration Drug Use
Description
Drug use will be examined as both binary responses (abstinence vs. any use) and frequency counts (number of days of use). These variables will be derived from information gained via Timeline Follow-Back Interview.
Time Frame
Approximately 3 months after release from incarceration
Title
Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration
Description
PTSD symptoms will be assessed using the 20-item PTSD Checklist (PCL-5). Response options are used to indicate the severity of each PTSD symptom and range from 0 (not at all) to 4 (extremely). Total scores range from 0-80. Lower scores indicate lower levels of PTSD symptoms and therefore a better treatment outcome.
Time Frame
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 Outcome Measure Information:
Title
Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration
Description
Depression symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Response options are using to indicate the severity of each symptom of depression and range from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Lower scores indicate lower levels of depression symptoms and therefore a better treatment outcome.
Time Frame
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.
Title
Recidivism
Description
Recidivism will be extracted from administrative incarceration records and examined as both a binary variable (presence or absence of any drug-related recidivism) and frequency counts (number of new drug charges).
Time Frame
12 months after release from incarceration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Zielinski, Phd
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Arkansas Community Correction Center (NEACCC)
City
Osceola
State/Province
Arkansas
ZIP/Postal Code
72370
Country
United States
Facility Name
East Central Arkansas Community Correction Center (ECACCC)
City
West Memphis
State/Province
Arkansas
ZIP/Postal Code
72301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In compliance with NIH's requirement for data sharing, final research data for this project will be made as available as possible upon request while safeguarding the privacy of participants. Individual-level data will be stripped of identifiers and unusual characteristics prior to sharing. A data sharing agreement with the PI will be required.
IPD Sharing Time Frame
12 months after publication of study primary outcome paper.
IPD Sharing Access Criteria
Completion of data sharing agreement with PI.
Citations:
PubMed Identifier
36181587
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.
Results Reference
derived

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Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users

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