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

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ClinicalTrials.gov Identifier: NCT04007666
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Drug Abuse Alcohol Abuse Posttraumatic Stress Disorder PTSD Recidivism Depression Behavioral: Cognitive Processing Therapy Behavioral: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Processing Therapy (CPT)
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).
Behavioral: Cognitive Processing Therapy
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.
Other Name: CPT

Active Comparator: Coping Skills Group
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).
Behavioral: Control Group
Coping-focused treatment drawn from material already offered in selected facilities.




Primary Outcome Measures :
  1. Post-Incarceration Drug Use [ Time Frame: Approximately 3 months after release from incarceration ]
    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.

  2. Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration [ 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. ]
    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 :
  1. Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration [ 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. ]
    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.

  2. Recidivism [ Time Frame: 12 months after release from incarceration ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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-incarcerated 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007666


Contacts
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Contact: Melissa Zielinski, PhD 501-526-8229 MJZielinski@uams.edu

Locations
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United States, Arkansas
Northeast Arkansas Community Correction Center (NEACCC) Not yet recruiting
Osceola, Arkansas, United States, 72370
Contact: Terry Maples    870-563-8330      
Contact: Syrna Bowers    870-563-8330      
East Central Arkansas Community Correction Center (ECACCC) Not yet recruiting
West Memphis, Arkansas, United States, 72301
Contact: Phyllis Silas    870-400-3101      
Contact: Phillip Glover         
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Melissa Zielinski, Phd University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04007666     History of Changes
Other Study ID Numbers: 229172
K23DA048162 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 12 months after publication of study primary outcome paper.
Access Criteria: Completion of data sharing agreement with PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arkansas:
Incarcerated
Prisoners
Implementation Science

Additional relevant MeSH terms:
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Disease
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Alcoholism
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders
Alcohol-Related Disorders