Substance Use DisordersNCT04007666
Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
A study testing Cognitive Processing Therapy in people with Substance Use Disorders and Drug Abuse, run by University of Arkansas at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Drug Abuse, Alcohol Abuse
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2019to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeast Arkansas Community Correction Center (NEACCC)
Osceola, Arkansas, 72370
East Central Arkansas Community Correction Center (ECACCC)
West Memphis, Arkansas, 72301
About this study
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.
- Conditions
- Substance Use Disorders, Drug Abuse, Alcohol Abuse, Posttraumatic Stress Disorder, PTSD, Recidivism
- Being tested
- Cognitive Processing Therapy, Control Group
- Keywords
- Incarcerated, Prisoners, Implementation Science
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Stress Disorders, Post-Traumatic, Recidivism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT
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.
Control GroupBehavioural
Coping-focused treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | 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). Receives: Behavioral: Cognitive Processing Therapy |
| Coping Skills Group | Active comparator | 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). Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 months after release from incarceration
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.
Measured: 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 (2)
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.
Measured: 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.
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).
Measured: 12 months after release from incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start16 Aug 2019
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Melissa Zielinski, Phd, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007666
- Sponsor's protocol ID
- 229172
- Other IDs
- K23DA048162
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2019
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36181587
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
- ClinicalTrials.gov ID
- NCT04007666
- Acronym / sponsor ID
- 229172
- Conditions
- Substance Use Disorders, Drug Abuse, Alcohol Abuse, Posttraumatic Stress Disorder, PTSD, Recidivism
- Keywords
- Incarcerated, Prisoners, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Behavioral: Cognitive Processing TherapyCPT 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). |
| Coping Skills Group | Active comparator | Behavioral: Control GroupThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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"
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing TherapyAlso: CPTCognitive 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. | Behavioural | Cognitive Processing Therapy (CPT) |
| Control GroupCoping-focused treatment. | Behavioural | Coping Skills Group |
Primary outcome
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.
2 secondary outcomes
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.
Recidivism
Time frame: 12 months after release from incarceration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 36181587Zielinski 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Zielinski, Phd principal investigator
University of Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy in people with Substance Use Disorders and Drug Abuse, run by University of Arkansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Incarceration Drug Use (time frame: Approximately 3 months after release from incarceration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.