PTSDNCT07283757
PTSD Treatment for Incarcerated Men and Women: AV
A study testing Cognitive Processing Therapy in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. 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
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to Dec 2029
- 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
Participants will be enrolled from the Department of Corrections trauma treatment waitlist who have been screened for:
- No active symptoms of psychosis that would interfere with the individual's ability to participate in the group
- No active suicidal ideation with intent or plan
- Able and willing to participate in group therapy
- 18 years old or older
- meet PCL-5 criteria for current PTSD diagnosis within 2 months of enrollment
- No scheduled release date before the end of the treatment group
- able to understand the consent form as measured by the consent quiz
- have not participated in the previous CPT groups with UW project
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychiatric Institute and Clinic
Madison, Wisconsin, 53719
Michael R Koenigs, PhD, 608-263-1679, mrkoenigs@wisc.edu
About this study
Official title: PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)
This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. A total of 692 participants will be enrolled from 6 locations and can expects to be on study for up to 24 weeks.
Read the detailed description
The primary objective of this project is to determine the effectiveness of group CPT in reducing conduct reports (violations of prison rules such assaults and substance use), reducing PTSD symptom severity, and address the long-term outcome of recidivism in male and female incarcerated populations.
Up to 692 incarcerated individuals will participate in group assignment. To account for potential participant attribution between consent, group assignment, and the waitlist group receiving treatment, enrollment could be up to 900 participants. AV branch of the study involves a waitlist control group; this group will receive the CPT treatment after the treatment group completes the treatment. Participation in the waitlist control group will not affect participation in any other treatments that are available at the facilities.
Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.
Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.
Eligible participants will complete the PCL-5 to ascertain current PTSD symptomology and probable diagnosis. This assessment will take approximately 90 minutes.
Participants will be randomly assigned to the CPT or the waitlist control group. The CPT group will engage in 8 -12, 90-minute treatment sessions (18 hours total). With the optional opportunity to take 15-20 minutes after each session to de-stress and calm down if necessary. These sessions will take place over 6 to 12 weeks, depending on session frequency. CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 10 participants, but no less than 3 will be included in each CPT group. When the waitlist control group reaches the treatment phase, if the participant count fall below 3, additional participants will be enrolled to maintain sufficient numbers. Data collection during treatment will mirror that of the active waitlist control group. Participants will be notified via institutional mail which group they have been enrolled in.
In addition to the treatment groups, CPT and control group members will complete a PCL-5 / PHQ-9 at the beginning of each session. As well as pre-treatment testing session prior to the start of treatment. CPT and control group members will complete post-treatment testing within one week after completing week 6 or 12 of treatment. Facilities will have the option to offer one follow up CPT session 6-12 weeks post-treatment. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. Participants who receive treatment may be selected for a 1on1 interview to hear about their experiences with the group. CPT and control group members will be asked to complete 15-19 sessions in total (pre-treatment, post- treatment, three-month follow-up treatment, 1on1 interview, 12 group sessions and one optional follow-up CPT session).
- Conditions
- PTSD
- Being tested
- Cognitive Processing Therapy
- Keywords
- Group therapy, Incarcerated Individuals
- 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: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered in 8 - 12, 90-minute sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) group | Experimental | Participant groups of 6-10 people to receive CPT to treat PTSD over 6 weeks or 12 weeks, depending on session frequency. Receives: Behavioral: Cognitive Processing Therapy |
| Waitlist Control | No intervention | Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Conduct Reports
Effectiveness of group CPT in reducing conduct reports measured by number of violations of prison rules such assaults and substance use.
Measured: Up to 26 weeks on study
Secondary outcomes (1)
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity). Participants will complete the PCL-5 questionnaire during pre-, post-, and three-month follow up timepoints.
Measured: baseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start22 Dec 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Model description
- Participants are assigned to one of two therapy-intervention groups: CPT or active waitlist control group. Participants will be stratified/randomized based on PTSD severity (PCL-5 total score).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Arnold Ventures
- Responsible party
- Sponsor
- Investigators
- Michael R Koenigs, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283757
- Sponsor's protocol ID
- 2018-0630: AV
- Other IDs
- A538900, Protocol Version 1/23/2026
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
James, D.J. and L.E. Glaze, Mental health problems of prison and jail inmates, U.S.D.o. Justice, Editor. 2006: Bureau of Justice Statistics Special Report.
Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209.
PubMed 25757522Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20.
PubMed 25697197Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.
Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
PubMed 12182270Morgan RD, Winterowd CL. Interpersonal process-oriented group psychotherapy with offender populations. Int J Offender Ther Comp Criminol. 2002 Aug;46(4):466-82. doi: 10.1177/0306624X02464008.
PubMed 12150085
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)
- ClinicalTrials.gov ID
- NCT07283757
- Acronym / sponsor ID
- 2018-0630: AV
- Conditions
- PTSD
- Keywords
- Group therapy, Incarcerated Individuals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Arnold Ventures
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Dec 2025 (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.
This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. A total of 692 participants will be enrolled from 6 locations and can expects to be on study for up to 24 weeks.
Detailed description
The primary objective of this project is to determine the effectiveness of group CPT in reducing conduct reports (violations of prison rules such assaults and substance use), reducing PTSD symptom severity, and address the long-term outcome of recidivism in male and female incarcerated populations.
Up to 692 incarcerated individuals will participate in group assignment. To account for potential participant attribution between consent, group assignment, and the waitlist group receiving treatment, enrollment could be up to 900 participants. AV branch of the study involves a waitlist control group; this group will receive the CPT treatment after the treatment group completes the treatment. Participation in the waitlist control group will not affect participation in any other treatments that are available at the facilities.
Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.
Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.
Eligible participants will complete the PCL-5 to ascertain current PTSD symptomology and probable diagnosis. This assessment will take approximately 90 minutes.
Participants will be randomly assigned to the CPT or the waitlist control group. The CPT group will engage in 8 -12, 90-minute treatment sessions (18 hours total). With the optional opportunity to take 15-20 minutes after each session to de-stress and calm down if necessary. These sessions will take place over 6 to 12 weeks, depending on session frequency. CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 10 participants, but no less than 3 will be included in each CPT group. When the waitlist control group reaches the treatment phase, if the participant count fall below 3, additional participants will be enrolled to maintain sufficient numbers. Data collection during treatment will mirror that of the active waitlist control group. Participants will be notified via institutional mail which group they have been enrolled in.
In addition to the treatment groups, CPT and control group members will complete a PCL-5 / PHQ-9 at the beginning of each session. As well as pre-treatment testing session prior to the start of treatment. CPT and control group members will complete post-treatment testing within one week after completing week 6 or 12 of treatment. Facilities will have the option to offer one follow up CPT session 6-12 weeks post-treatment. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. Participants who receive treatment may be selected for a 1on1 interview to hear about their experiences with the group. CPT and control group members will be asked to complete 15-19 sessions in total (pre-treatment, post- treatment, three-month follow-up treatment, 1on1 interview, 12 group sessions and one optional follow-up CPT session).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two therapy-intervention groups: CPT or active waitlist control group. Participants will be stratified/randomized based on PTSD severity (PCL-5 total score).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) group | Experimental | Behavioral: Cognitive Processing TherapyParticipant groups of 6-10 people to receive CPT to treat PTSD over 6 weeks or 12 weeks, depending on session frequency. |
| Waitlist Control | No intervention | –Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered in 8 - 12, 90-minute sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. | Behavioural | Cognitive Processing Therapy (CPT) group |
Primary outcome
Number of Conduct Reports
Time frame: Up to 26 weeks on study
Effectiveness of group CPT in reducing conduct reports measured by number of violations of prison rules such assaults and substance use.
1 secondary outcome
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
Time frame: baseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- BackgroundJames, D.J. and L.E. Glaze, Mental health problems of prison and jail inmates, U.S.D.o. Justice, Editor. 2006: Bureau of Justice Statistics Special Report.
- Background: PubMed 25757522Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209.
- Background: PubMed 25697197Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20.
- BackgroundResick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.
- Background: PubMed 12182270Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
- Background: PubMed 12150085Morgan RD, Winterowd CL. Interpersonal process-oriented group psychotherapy with offender populations. Int J Offender Ther Comp Criminol. 2002 Aug;46(4):466-82. doi: 10.1177/0306624X02464008.
- PTSD Treatment for Incarcerated Men and Women: WPPLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael R 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?
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 30 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 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?
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 Michael R Koenigs, PhD ((608) 263-1679, mrkoenigs@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Conduct Reports (time frame: Up to 26 weeks on study). 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 NCT07283757, which also lists 6 linked publications.
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 30 Jan 2026.