PTSDNCT06019767
Peer-led Trauma Therapy for Re-entry
A study testing Cognitive Processing Therapy in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- 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
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 12 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- completed a prison or jail sentence
- no current psychosis symptoms
- no active self-harm or active suicidal intent
- able and willing to participate in group therapy
- meet criteria for PTSD treatment need
Who cannot join
- current and active psychosis
- current and active self-harm and suicidality
- no PTSD diagnosis
- current substance use dependence (not including those used as prescribed for medical reasons) on alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.
Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.
Read the detailed description
Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).
Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 48 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.
Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.
- Conditions
- PTSD
- Being tested
- Cognitive Processing Therapy
- Keywords
- Previously incarcerated, Group therapy, Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
CPT is a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Groups of 6-8 receive CPT to treat PTSD Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Participation
Will be measured as the percentage of invited, eligible individuals who elect to participate.
Measured: Study duration (up to 2 years)
Feasibility: Rate of retention
Will be measured by percentage of participants who complete at least 9 of the 12 study sessions
Measured: Study duration (up to 2 years)
Feasibility: Compliance through participation
Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.
Measured: Study duration (up to 2 years)
Feasibility: Compliance through homework
Will be measured by percentage of participants completing homework assignments each week.
Measured: Study duration (up to 2 years)
Feasibility: Compliance through completing assessments
Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.
Measured: Study duration (up to 2 years)
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.
Measured: Study duration (up to 2 years)
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
Higher ratings indicate higher-quality session element (scores 1-7; 1=not satisfactory, 4= satisfactory, 7=excellent) by the clinical supervisor. Assesses for therapist compliance as secondary measure of intervention efficacy.
Measured: Study duration (up to 2 years)
Change in suicide and self-harm ideation
Beck Depression Inventory-II (BDI-II), item 9. Participants will answer the item on a scale of 0-3, where a score of 2 or 3 indicates higher ideation.
Measured: Baseline to end of follow-up (up to 4.5 months)
Participant satisfaction
Using the 8 item Client Satisfaction Questionnaire (CSQ-8), participants will rate their satisfaction with their experience. Scale ranges from 1-4, with total potential scores of 8 to 32 with higher scores indicating greater satisfaction.
Measured: One week post-treatment (up to 7 weeks)
Change in PTSD symptom severity
Using the PTSD Checklist for DSM-5 (PCL-5), which is a 20-item self-report measure, symptoms of PTSD will be assessed. Participants will answer items on a scale of 0-4, where 0=Not at all and 4=Extremely. Higher scores indicate higher symptom severity.
Measured: Baseline to end of follow-up (up to 4.5 months)
Secondary outcomes (5)
Change in depression symptom severity
Beck Depression Inventory-II (BDI-II), which is a 21-item self-report measure to assess depression severity. Participants will answer items on a scale of 0-3, where lower scores indicate lower severity.
Measured: Baseline to end of follow-up (up to 4.5 months)
Change in trauma related thoughts and beliefs
Posttraumatic Cognitions Inventory (PTCI) is a 33-item measure of negative cognition about the world, negative self-related thoughts, and self-blame. Participants rate each item on a scale of 1-7, 1=totally disagree, 4=neutral, 7=totally agree. Higher scores indicate greater levels of trauma.
Measured: Baseline to end of follow-up (up to 4.5 months)
Change in aspects of hopelessness
Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.
Measured: Baseline to end of follow-up (up to 4.5 months)
Change in substance use
Tobacco, Alcohol, Prescription Medication, and other Substance Use Tool (TAPS) screens for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year, as well as the past 3 months.
Measured: Baseline to end of follow-up (up to 4.5 months)
Change in anxiety symptom severity
Beck Anxiety Inventory (BAI), which is a 21-item self-report measure to assess anxiety severity. Participants will rate how much items bothered them as: Not at all; Mildly but it didn't bother me much; Moderately - it wasn't pleasant at times; or, Severely - it bothered me a lot. More symptoms that caused moderate or severe bother indicate higher severity of anxiety.
Measured: Baseline to end of follow-up (up to 4.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start14 Nov 2023
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Koenigs, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019767
- Sponsor's protocol ID
- 2023-1144
- Other IDs
- Protocol Version 12/02/24, SMPH/PSYCHIATRY/PSYCHIATRY
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Trauma Therapy for Re-entry
- ClinicalTrials.gov ID
- NCT06019767
- Acronym / sponsor ID
- 2023-1144
- Conditions
- PTSD
- Keywords
- Previously incarcerated, Group therapy, Cognitive Processing Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 31 Aug 2023 (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 purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.
Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.
Detailed description
Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).
Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 48 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.
Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Behavioral: Cognitive Processing TherapyGroups of 6-8 receive CPT to treat PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- completed a prison or jail sentence
- no current psychosis symptoms
- no active self-harm or active suicidal intent
- able and willing to participate in group therapy
Key exclusion criteria (4 listed)
- current and active psychosis
- current and active self-harm and suicidality
- no PTSD diagnosis
- current substance use dependence (not including those used as prescribed for medical reasons) on alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids
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 TherapyCPT is a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups. | Behavioural | Cognitive Processing Therapy (CPT) |
Primary outcome
Feasibility: Participation
Time frame: Study duration (up to 2 years)
Will be measured as the percentage of invited, eligible individuals who elect to participate.
Feasibility: Rate of retention
Time frame: Study duration (up to 2 years)
Will be measured by percentage of participants who complete at least 9 of the 12 study sessions
Feasibility: Compliance through participation
Time frame: Study duration (up to 2 years)
Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.
Feasibility: Compliance through homework
Time frame: Study duration (up to 2 years)
Will be measured by percentage of participants completing homework assignments each week.
Feasibility: Compliance through completing assessments
Time frame: Study duration (up to 2 years)
Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
Time frame: Study duration (up to 2 years)
Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
Time frame: Study duration (up to 2 years)
Higher ratings indicate higher-quality session element (scores 1-7; 1=not satisfactory, 4= satisfactory, 7=excellent) by the clinical supervisor. Assesses for therapist compliance as secondary measure of intervention efficacy.
Change in suicide and self-harm ideation
Time frame: Baseline to end of follow-up (up to 4.5 months)
Beck Depression Inventory-II (BDI-II), item 9. Participants will answer the item on a scale of 0-3, where a score of 2 or 3 indicates higher ideation.
Participant satisfaction
Time frame: One week post-treatment (up to 7 weeks)
Using the 8 item Client Satisfaction Questionnaire (CSQ-8), participants will rate their satisfaction with their experience. Scale ranges from 1-4, with total potential scores of 8 to 32 with higher scores indicating greater satisfaction.
Change in PTSD symptom severity
Time frame: Baseline to end of follow-up (up to 4.5 months)
Using the PTSD Checklist for DSM-5 (PCL-5), which is a 20-item self-report measure, symptoms of PTSD will be assessed. Participants will answer items on a scale of 0-4, where 0=Not at all and 4=Extremely. Higher scores indicate higher symptom severity.
5 secondary outcomes
Change in depression symptom severity
Time frame: Baseline to end of follow-up (up to 4.5 months)
Change in trauma related thoughts and beliefs
Time frame: Baseline to end of follow-up (up to 4.5 months)
Change in aspects of hopelessness
Time frame: Baseline to end of follow-up (up to 4.5 months)
Change in substance use
Time frame: Baseline to end of follow-up (up to 4.5 months)
Change in anxiety symptom severity
Time frame: Baseline to end of follow-up (up to 4.5 months)
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 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for PTSD
Not yet recruiting
Salience Network Informed rTMS for PTSD
Stress Disorders, Post-Traumatic
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Michael Koenigs, PhD principal investigator
University of Wisconsin, Madison
1 site 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 PTSD, run by University of Wisconsin, Madison at 1 site 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 6 inclusion and 4 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility: Participation (time frame: Study duration (up to 2 years)). The study lists 10 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 20 Jul 2026.