Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-01 @ 8:08 AM
Study NCT ID:
NCT07283757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PTSD Treatment for Incarcerated Men and Women: AV
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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 10-12, 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).
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 10-12, 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: