An interventional study of Cognitive Processing Therapy in PTSD, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
Study examining the feasibility of and 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 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.
Overall Study Objectives:
The primary objectives of this project include:
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 first complete the Clinician-Administered PTSD Scale for DSM-5 (PCL-5) to ascertain current PTSD symptomology and diagnosis. Participants will then be assigned to the CPT groups. The CPT groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 6 participants will be included in each CPT session. Participants will be notified via institutional mail when they are starting CPT. Participants will be able to continue any ongoing treatment/interventions they are engaged in within the institution. All participants will be asked what treatment groups they are currently enrolled in during the initial screening to examine the possibility of attentional bias within the CPT group (i.e., more frequent interaction leading to treatment outcomes).
In addition to the treatment groups, CPT group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. After treatment session 5, group members will complete mid-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 group members will then complete post-treatment testing within one week after completing treatment (group session 12). One month after the treatment is completed, group members will complete the first round of follow-up testing. Three months after the treatment is completed, group members will complete the final round of follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. The three month follow-up session will be identical, with the addition of the PCL-5 interview to re-assess PTSD diagnosis. Group members will be asked to complete 18 sessions in total (pre-, mid-, post-, one-month follow-up testing, three month follow-up testing, 12 treatment groups, and 1 post-intervention focus group).
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) receive CPT to treat PTSD
Behavioral: Cognitive Processing Therapy
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.
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
Intervention feasibility measured primarily by participant retention
Time frame: up to 6 weeks (by the end of 12th session)
Change in Self-reported PTSD Symptoms (PCL-5)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.
Time frame: baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)
Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)
Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame: Post (1 week post-intervention, up to 13 weeks on study)
Percentage of Individuals That Meet Study Inclusion Criteria
Assesses for participant eligibility as secondary measure of intervention feasibility.
Time frame: baseline (one week prior to intervention)
Percentage of Eligible Individuals Enrolled in the Study
Assesses for participant interest as secondary measure of intervention feasibility.
Time frame: up to start of intervention
Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)
Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
Time frame: By the end of final treatment session (up to 12 weeks)
Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets
Assesses for participant compliance: extent to which participants complied with treatment skill practice
Time frame: By the end of final treatment session (up to 12 weeks)
Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor
Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.
Time frame: By the end of final treatment session (up to 12 weeks)
Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist
Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.
Time frame: By the end of final treatment session (up to 12 weeks)
Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 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. Assesses for participant safety as secondary measure of intervention feasibility.
Time frame: post (one week post-intervention, up to 13 weeks on study)
Reasons for Participant Discontinuation
We will collect information on participant dropout reasons to understand reasons for discontinuation
Time frame: Up to 3 month follow up (up to 25 weeks)
| Milestone | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Started | 35 | 34 |
| Screened | 55 | 47 |
| Consented to participate | 46 | 43 |
| Eligible to participate | 43 | 36 |
| Started intervention | 34 | 34 |
| Participants providing data at 1-week follow up | 31 | 32 |
| Completed | 31 | 32 |
| Not completed | 4 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Withdrawn by therapist | 1 | 1 |
| Withdrew: Left facility | 1 | 0 |
Intervention feasibility measured primarily by participant retention
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | 31 | 32 |
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.
| score on a scale | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Change in Self-reported PTSD Symptoms (PCL-5) | -19.07 (-58 to -13) | -12.94 (-43 to -12.94) |
Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
| units on a scale | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | 28.48 ± 3.93 | 25.7 ± 4.74 |
Assesses for participant eligibility as secondary measure of intervention feasibility.
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Percentage of Individuals That Meet Study Inclusion Criteria | 43 | 36 |
Assesses for participant interest as secondary measure of intervention feasibility.
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Percentage of Eligible Individuals Enrolled in the Study | 35 | 34 |
Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | 31 | 30 |
Assesses for participant compliance: extent to which participants complied with treatment skill practice
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | 21 | 22 |
Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.
| Percentage of session elements present | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor | 87.72 | 85.96 |
Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.
| CPT session elements | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Unique Items | 4.67 ± .57 | 4.35 ± .5 |
| Essential Items | 4.77 ± .43 | 4.36 ± .53 |
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. Assesses for participant safety as secondary measure of intervention feasibility.
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | 0 | 2 |
We will collect information on participant dropout reasons to understand reasons for discontinuation
| Participants | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Transferred Facilities | 1 | 0 |
| Scheduling Issues | 1 | 0 |
| Group "Not Helpful" | 1 | 0 |
| Work | 0 | 2 |
| Withdrawn by study clinician | 0 | 2 |
Collected over Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women's Facility Cognitive Processing Therapy (CPT) | 0/35 (0%) | 0/35 (0%) | 7/35 (20%) |
| Men's Facility Cognitive Processing Therapy (CPT) | 0/34 (0%) | 0/34 (0%) | 14/34 (41.2%) |
| Event | Women's Facility Cognitive Processing Therapy (CPT) | Men's Facility Cognitive Processing Therapy (CPT) |
|---|---|---|
| Medical EventCardiac disorders | 1/35 | 5/34 |
| Social CircusmtancesSocial circumstances | 0/35 | 4/34 |
| Increased PTSD symptomsPsychiatric disorders | 1/35 | 3/34 |
| Increase in depressive symptomsPsychiatric disorders | 0/35 | 3/34 |
| Segregated Housing Placement / Rule ViolationSocial circumstances | 3/35 | 3/34 |
| Passive Suicidal IdeationPsychiatric disorders | 0/35 | 2/34 |
| Increased emotional distressPsychiatric disorders | 2/35 | 0/34 |
| Age, Continuous(years) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Mean | 36.09 ± 10.78 | 39.6 ± 11.3 | 38.12 ± 11.23 |
| Sex: Female, Male(Participants) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Female | 35 | 0 | 35 |
| Male | 0 | 34 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 35 | 32 | 67 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Womens Facility — American Indian or Alaska Native | 2 | 0 | 2 |
| Womens Facility — Asian | 0 | 1 | 1 |
| Womens Facility — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Womens Facility — Black or African American | 3 | 14 | 17 |
| Womens Facility — White | 28 | 17 | 45 |
| Womens Facility — More than one race | 1 | 2 | 3 |
| Womens Facility — Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| United States | 35 | 34 | 69 |
| PCL-5(units on a scale) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Mean | 50.49 ± 12.29 | 47.26 ± 10.31 | 48.90 ± 11.39 |
| Beck Anxiety Inventory (BAI)(score on a scale) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Mean | 22.57 ± 9.72 | 25.03 ± 9.32 | 23.72 ± 9.54 |
| Beck Depression Inventory 2 (BDI-II)(score on a scale) | Women's Facility Cognitive Processing Therapy (CPT) Group | Men's Facility Cognitive Processing Therapy (CPT) | Total |
|---|---|---|---|
| Mean | 30.14 ± 11.41 | 29.94 ± 9.17 | 30.04 ± 10.29 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Wisconsin, Madison