PTSDNCT05432817
PTSD Treatment for Incarcerated Men and Women: WPP
A study testing Cognitive Processing Therapy in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of individuals for both CPT and waitlist control in both… 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
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 24 Apr 2026
- 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 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychiatric Institute and Clinic
Madison, Wisconsin, 53719
About this study
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of individuals for both CPT and waitlist control in both populations (180 participants total).
Read the detailed description
Overall Study Objectives:
The primary objectives of this project include:
- Determine the effectiveness of CPT in reducing PTSD symptom severity;
- Identify putative psychological mechanisms of response to CPT through pre-, mid-, and post-intervention measures of PTSD symptom severity as well as measures of hopelessness, self-blame, and negative self-related thoughts.
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 active control groups. The CPT group will engage in 10 to 12, 90-minute treatment sessions (up to 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 at the beginning of each session. As well as, pre-treatment testing session two weeks prior to the start of treatment. After treatment session 5, CPT and control group members will complete mid-treatment testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT and control group members will then complete post-treatment testing within one week after completing week 6 of treatment. One month after the treatment is completed, CPT and control group members will complete follow-up testing and interviewing about their experience in the treatment groups and will have one follow up CPT session 6-8 weeks post-treatment. Post-treatment and one-month follow up-testing will follow the same procedure as pre-treatment and mid-treatment testing. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. CPT and control group members will be asked to complete 18 sessions in total (pre-treatment, mid- treatment, post- treatment, one-month follow up-testing, three-month follow-up treatment, 12 group sessions and one 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 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) group | Experimental | Participant groups to receive CPT to treat PTSD 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.
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); primary measure of intervention efficacy
Measured: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Secondary outcomes (5)
Change in score on the Beck Depression Inventory 2 (BDI-II)
Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy
Measured: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Change in score on the Beck Anxiety Inventory (BAI)
Anxiety level measured by score on BAI (between 0 and 63; over 30 = severe anxiety); secondary measure of intervention efficacy
Measured: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Percentage of participants endorsing 2 or higher on Q9 of BDI-II
Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution.
Measured: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
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. For each 12-session intervention, 2 sessions will be audiotaped and rated.
Measured: Up to 7 weeks (by the end of the 12th session)
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 supervisors. Competence ratings will be collected for two audiotaped group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention efficacy.
Measured: Up to 7 weeks (by the end of the 12th session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start4 Jan 2024
- Primary completion30 Jan 2026
- Study completion24 Apr 2026
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 waitlit control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Responsible party
- Sponsor
- Investigators
- Michael R Koenigs, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432817
- Sponsor's protocol ID
- 2018-0630: WPP
- Other IDs
- A538900, Protocol Version 5/21/2025
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2022
- Last updated
- 24 Apr 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Treatment for Incarcerated Men and Women: WPP
- ClinicalTrials.gov ID
- NCT05432817
- Acronym / sponsor ID
- 2018-0630: WPP
- Conditions
- PTSD
- Keywords
- Group therapy, Incarcerated Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 27 Jun 2022 (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.
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of individuals for both CPT and waitlist control in both populations (180 participants total).
Detailed description
Overall Study Objectives:
The primary objectives of this project include:
- Determine the effectiveness of CPT in reducing PTSD symptom severity;
- Identify putative psychological mechanisms of response to CPT through pre-, mid-, and post-intervention measures of PTSD symptom severity as well as measures of hopelessness, self-blame, and negative self-related thoughts.
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 active control groups. The CPT group will engage in 10 to 12, 90-minute treatment sessions (up to 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 at the beginning of each session. As well as, pre-treatment testing session two weeks prior to the start of treatment. After treatment session 5, CPT and control group members will complete mid-treatment testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT and control group members will then complete post-treatment testing within one week after completing week 6 of treatment. One month after the treatment is completed, CPT and control group members will complete follow-up testing and interviewing about their experience in the treatment groups and will have one follow up CPT session 6-8 weeks post-treatment. Post-treatment and one-month follow up-testing will follow the same procedure as pre-treatment and mid-treatment testing. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. CPT and control group members will be asked to complete 18 sessions in total (pre-treatment, mid- treatment, post- treatment, one-month follow up-testing, three-month follow-up treatment, 12 group sessions and one 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 waitlit control group
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) group | Experimental | Behavioral: Cognitive Processing TherapyParticipant groups to receive CPT to treat PTSD |
| 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
Key inclusion criteria (8 listed)
- 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
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 TherapyCPT: 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) group |
Primary outcome
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
Time frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy
5 secondary outcomes
Change in score on the Beck Depression Inventory 2 (BDI-II)
Time frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Change in score on the Beck Anxiety Inventory (BAI)
Time frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Percentage of participants endorsing 2 or higher on Q9 of BDI-II
Time frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
Time frame: Up to 7 weeks (by the end of the 12th session)
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
Time frame: Up to 7 weeks (by the end of the 12th session)
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 24 Apr 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.
- 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. This study is not recruiting at the moment.
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?
The sponsor lists 8 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 24 Apr 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?
Change in PTSD Checklist for DSM-5 (PCL-5) severity score (time frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)). 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 NCT05432817, 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 24 Apr 2026.