PTSD Treatment for Incarcerated Men and Women: NIMH
- Conditions
- PTSD
- Registration Number
- NCT05168267
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
Overall Study Objectives:
The primary objectives of this project include:
1. Establish the feasibility of group CPT delivery in male and female incarcerated populations with PTSD;
2. Establish the acceptability of group CPT delivery in male and female incarcerated populations with PTSD;
3. Establish feasibility of assessment collection for primary outcome measures, secondary outcome measures, and potential mediators and moderators during a clinical trial examining group CPT delivery in incarcerated settings.
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- Intelligence quotient (IQ) greater than or equal to 70
- 18 years old or older
- Reading level of 4th grade or higher
- stable medication use (same medication for at least one month)
- able and willing to participate in group therapy
- meet PCL-5 criteria for a current PTSD diagnosis within two months of study enrollment
- no scheduled release date before the end of the treatment group
- currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Self-reported PTSD Symptoms (PCL-5) baseline (one week prior to intervention), post-intervention (up to 13 weeks on study) 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.
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions up to 6 weeks (by the end of 12th session) Intervention feasibility measured primarily by participant retention
Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) Post (1 week post-intervention, up to 13 weeks on study) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Individuals That Meet Study Inclusion Criteria baseline (one week prior to intervention) Assesses for participant eligibility as secondary measure of intervention feasibility.
Percentage of Eligible Individuals Enrolled in the Study up to start of intervention Assesses for participant interest as secondary measure of intervention feasibility.
Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) By the end of final treatment session (up to 12 weeks) Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist By the end of final treatment session (up to 12 weeks) 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.
Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets By the end of final treatment session (up to 12 weeks) Assesses for participant compliance: extent to which participants complied with treatment skill practice
Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor By the end of final treatment session (up to 12 weeks) 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.
Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) post (one week post-intervention, up to 13 weeks on study) 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.
Reasons for Participant Discontinuation Up to 3 month follow up (up to 25 weeks) We will collect information on participant dropout reasons to understand reasons for discontinuation
Trial Locations
- Locations (1)
Psychiatric Institute and Clinic
🇺🇸Madison, Wisconsin, United States
Psychiatric Institute and Clinic🇺🇸Madison, Wisconsin, United States