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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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).
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
|Contact: Melissa Zielinski, PhD||501-526-8229||MJZielinski@uams.edu|
|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|
|Principal Investigator:||Melissa Zielinski, Phd||University of Arkansas|