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| ID | Type | Description | Link |
|---|---|---|---|
| A538900 | Other Identifier | UW Madison | |
| Protocol Version 5/21/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Wisconsin Partnership Program | OTHER |
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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).
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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy (CPT) group | Experimental | Participant groups to receive CPT to treat PTSD |
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| Waitlist Control | No Intervention | Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Participants will be selected and screened from the Department of Corrections trauma treatment waitlist.
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Koenigs, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Institute and Clinic | Madison | Wisconsin | 53719 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 25757522 | Background | 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. | |
| 25697197 |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Participants are assigned to one of two therapy-intervention groups: CPT or active waitlit control group
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| 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 | 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. | 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. | 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. | Up to 7 weeks (by the end of the 12th session) |
| Background |
| Campbell 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. |
| Background | Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press. |
| 12182270 | Background | 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. |
| 12150085 | Background | Morgan 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. |