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PTSD - Post Traumatic Stress DisorderSTRIDES2NCT06923423

Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons

A study testing Group Cognitive Processing Therapy (CPT) in people with PTSD - Post Traumatic Stress Disorder and PTSD and Alcohol Use Disorder, run by University of Arkansas at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group Cognitive Processing Therapy (CPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
6 sitesUnited States
Study dates
7 Jul 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • 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
  • All items listed in "Inclusion criteria for all participants"
  • Be currently incarcerated in one of the prisons that have partnered as study sites
  • Have met criteria for a drug use disorder in the year prior to their current incarceration (≥ 2 symptoms on a DSM-5 drug use disorder checklist)
Show all 16Show fewer
  • Have used drugs in the 30 days prior to their current incarceration
  • Have a history of traumatic event exposure
  • Endorse clinically significant posttraumatic stress symptoms (score ≥ 4 on the Primary Care PTSD Screen for DSM-5; PC-PTSD-5)
  • Expect to be incarcerated for at least long enough to complete CPT-CJ as it is being implemented at the particular site (i.e., anticipated to be ~3 months, but will depend on dates associated with next available intervention group)
  • Expect to be released from prison within 12 months following the end of treatment (i.e., within ~15 months of the pre-treatment assessment)
  • Willing to consent to randomization to treatment condition
  • Exclusion criteria for prisoners (additional requirements assessed during pre-treatment assessments or indicated by prison staff; will result in being withdrawn from the study prior to randomization by the PI):
  • Unable to provide any locator information for post-release assessments
  • Determined to be releasing sooner than would allow the individual to complete CPT-CJ
  • Determined to have an unavoidable scheduling conflict or facility restriction (e.g., disciplinary, medical) that would prevent participation in CPT-CJ. Of note, if the scheduling conflict or facility restriction is expected to resolve following the next round of randomization at the study site, the participant may be put on "hold for next round" status rather than withdrawn unless other exclusionary criteria would be met by that time (e.g., release).

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa J Zielinski, PhD contact

501-526-8229

MJZielinski@uams.edu

Mollee K Smith Steely, PhD contact

501-320-7271

MKSteelysmith@uams.edu

6 sites in 1 country

United States6 sites, 6 recruiting
  • North Dakota State Penitentiary (NDSP)

    Bismarck, North Dakota, 58501

    Recruiting
  • Heart River Correctional Center (HRCC)

    Bismarck, North Dakota, 58502

    Recruiting
  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Melissa J Zielinski, PhD, 501-526-8229, MJZielinski@uams.edu

    Melissa J Zielinski, PhD

    Not yet recruiting
  • Northeast Arkansas Community Corrections Center (NEACC)

    Osceola, Arkansas, 72370

    Recruiting
  • Southwest Arkansas Community Correction Center

    Texarkana, Arkansas, 71854

    John Miners

    Recruiting
  • East Central Arkansas Community Correction Center

    West Memphis, Arkansas, 72301

    Tameka Coleman

    Recruiting

Other trials in United States

About this study

Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release.

The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook

Read more

This study will:

  • test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared to trauma-focused self-help,
  • evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and
  • measure the cost of the therapies and support strategies to help plan for future expansion.

Incarcerated participants (N = 640; 50% female) will be enrolled from ~10 prisons in ~5 states, ensuring variability in population and setting characteristics. They will:

  • take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison)
  • complete CPT group therapy or self-help therapy
  • provide urine samples 3 months and 6 months after leaving prison

Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = ~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.

Being tested
Group Cognitive Processing Therapy (CPT), Control Group Individual trauma focused self-help via workbook
Keywords
Post traumatic Stress Disorder, Post traumatic Stress Symptoms, Substance Use, Substance Use Disorder, Cognitive Processing Therapy, Cognitive Processing Therapy for Criminal Justice Setting, Trauma focused self help, Facilitation, Implementation Facilitation, Implementation, Cost Estimation and Offsets, Drug Use Disorder, Alcohol Use Disorder, Trauma, Depression, Adult, Incarcerated, Prison, Imprisonment, Intervention
Medical subject headings
Combat Disorders, Stress Disorders, Post-Traumatic, Alcoholism, Substance-Related Disorders, Depression, Psychological Well-Being, Wounds and Injuries, Stress Disorders, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Cognitive Processing Therapy (CPT)Behavioural

    Also called CPT-CJ

    Participants in CPT group therapy will learn about trauma and how to change upsetting thoughts related to it. Participants will attend up to a total of 12 sessions held 1-2x/week for 90 minutes. No more than 10 participants will be in a group. In this study, CPT provided is a version that was adapted for prisons.

  • Control Group Individual trauma focused self-help via workbookBehavioural

    The self-help therapy is a therapy that people do on their own using a workbook. By reading and doing practice assignments in the workbook, people can learn skills to recover from trauma.

Study groups in NCT06923423
Study groupRoleWhat they receive
Group Cognitive Processing Therapy (CPT)Active comparatorParticipants in CPT group therapy will learn about trauma and how to change upsetting thoughts related to it. Participants will attend up to a total of 12 sessions held 1-2x/week for 90 minutes. No more than 10 participants will be in a group. In this study, CPT provided is a version that was adapted for prisons (CPT-CJ).
Receives: Behavioral: Group Cognitive Processing Therapy (CPT)
Individual trauma focused self-help via workbookActive comparatorParticipants in the trauma-focused self-help therapy will independently read and do practice assignments in a workbook to learn skills to recover from trauma.
Receives: Behavioral: Control Group Individual trauma focused self-help via workbook

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug Use Frequency (Count)

    Participants complete a Timeline Follow Back Interview assessment of illicit drug use during the previous 30 days at 3- \& 6-months post-release from prison. The total number of days of drug use will be summed to represent drug use frequency.

    Measured: 3- and 6-month post-release from prison

  2. Drug use (Binary)

    Participants complete a Timeline Follow Back Interview assessment of illicit drug use during the previous 30 days at 3- \& 6-months post-release from prison. The total number of days of drug use will be dichotomized to indicate presence or absence of drug use since release.

    Measured: 3- and 6-month post-release from prison

  3. Posttraumatic Stress Symptom Severity (Sum)

    Participants complete the PTSD Checklist for DSM-5 (PCL-5) at all assessments to examine change the effectiveness of the intervention and control groups on posttraumatic stress symptom severity. Scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

    Measured: Pre-treatment assessments will be ~2 wks before tx starts; post-treatment will be ~2 wks after tx ends; pre-release will be ~3 days before release; post-release follow-ups will be 3- and 6-mo after prison exist

  4. Treatment fidelity (ratio)

    The ratio of the number of CPT-CJ components delivered to the number of CPT-CJ components planned per completed fidelity monitoring templates.

    Measured: Fidelity assessments will be done during the active treatment period which can be as short as 6 weeks to as long as 3 months for participants. The active treatment period is expected to span 1.5 years at each site.

Secondary outcomes (18)
  1. Drug Use Disorder Symptom Severity (Count)

    Participants will complete a DSM-5 checklist of drug use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed.

    Measured: 3- and 6-months post-release from prison

  2. Drug Use Disorder (Binary)

    Participants will complete a DSM-5 checklist of drug use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed. Sum score will be used to determine substance use disorder presence (i.e., scores ≥ 2) or absence (scores of 0-1).

    Measured: 3- and 6-months post-release from prison

  3. Depressive Symptom Severity (Sum)

    Participants will complete the Patient Health Questionnaire - 8-item (PHQ-8) at all assessments to examine change the effectiveness of the intervention and control groups on depressive symptom severity. Scores range from 0-24 with higher scores indicating more severe depressive symptoms.

    Measured: Pre-treatment assessments will be done ~2 wks before tx starts; post-treatment will be ~2 wks after tx ends; pre-release will be ~3 days before release; post-release follow-ups will be ~3- and ~6-mo after prison exit

  4. Alcohol Use Frequency (Count)

    Participants will complete a Timeline Follow Back Interview assessment of alcohol use during the previous 30 days at both 3- and 6-months post-release from prison. The total number of days of alcohol use will be summed to represent drug use frequency.

    Measured: 3- and 6-months post-release from prison

  5. Alcohol Use (Binary)

    Participants will complete a Timeline Follow Back Interview assessment of alcohol use during the previous 30 days at both 3- and 6-months post-release from prison. The total number of days of alcohol use will be dichotomized to indicate presence or absence of alcohol use since release.

    Measured: 3- and 6-months post-release from prison

  6. Alcohol Use Disorder Symptom Severity (Count)

    Participants will complete a DSM-5 checklist of alcohol use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed.

    Measured: 3- and 6-months post-release from prison

  7. Alcohol Use Disorder (Binary)

    Participants will complete a DSM-5 checklist of alcohol use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed. Sum score will be used to determine substance use disorder presence (i.e., scores ≥ 2) or absence (scores of 0-1).

    Measured: 3- and 6-months post-release from prison

  8. Drug-Related Crime Frequency (Count)

    Sum of new arrests and new convictions for drug charges based on the Criminal and Legal Activities Form and, if sufficient data is available, administrative records.

    Measured: 6-months post-release from prison

  9. Drug Related Crime (Binary)

    Presence or absence of any new arrests or new convictions for drug charges based on the Criminal and Legal Activities Form and, if sufficient data is available, administrative records.

    Measured: 6-months post-release from prison

  10. Substance-Related Disciplinary Violations (Count)

    Sum of substance-related disciplinary violations received while incarcerated per administrative records

    Measured: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years

  11. Substance-Related Disciplinary Violations (Binary)

    Presence or absence of any substance-related disciplinary violations received while incarcerated per administrative records.

    Measured: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years

  12. Positive Urine Drug Screens (Binary)

    Presence or absence of any positive urine drug screens following release from prison per department of corrections administrative records.

    Measured: 3- and 6-months post-release from prison

  13. Treatment Acceptability (mean)

    Prison residents and stakeholders will complete the Acceptability of Intervention Measure (AIM) to index treatment acceptability. Mean scores on the AIM range from 1-5, with higher scores indicating greater intervention acceptability.

    Measured: Post-treatment assessments will be completed 2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)

  14. Treatment Acceptability (sum)

    Prison residents will complete the Client Satisfaction Questionnaire (CSQ-8) as an additional index of treatment acceptability. Sum scores on the CSQ-8 range from 8-32, with higher scores indicating greater intervention acceptability.

    Measured: Administered at post-treatment assessment, which will be completed ~2 weeks after treatment ends

  15. Treatment appropriateness (mean)

    The Intervention Appropriateness Measure (IAM) will be completed by both prison residents and prison stakeholders. Mean scores on the IAM range from 1-5, with higher scores indicating greater intervention appropriateness.

    Measured: Post-treatment assessments will be completed ~2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)

  16. Treatment feasibility (mean)

    The Feasibility of Intervention Measure (FIM) will be completed by prison stakeholders to index treatment feasibility. Mean scores on the FIM range from 1-5, with higher scores indicating greater intervention feasibility.

    Measured: Immediately and 12-months post-implementation

  17. Treatment adoption (ratio)

    Ratio of patients who completed CPT-CJ to the number who were randomized

    Measured: Treatment adoption assessment will be done during the active treatment period, which can be as short as 6 weeks to as long as 3 months for participants. The active treatment period is expected to span 1.5 years at each site

  18. Treatment sustainability (ratio)

    The number of sites of total that are maintaining or increasing in CPT-CJ provision with high fidelity after implementation facilitation support is withdrawn.

    Measured: 1-year post-implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study start7 Jul 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
640 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06923423
Sponsor's protocol ID
297770
Other IDs
R01DA059549
Acronym
STRIDES2
Status last verified
Jan 2026
First submitted
3 Feb 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Processing Therapy (CPT) in people with PTSD - Post Traumatic Stress Disorder and PTSD and Alcohol Use Disorder, run by University of Arkansas at 6 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 16 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa J Zielinski, PhD (501-526-8229, MJZielinski@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug Use Frequency (Count) (time frame: 3- and 6-month post-release from prison). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Jan 2026.

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