Clinical trial NCT05432817: PTSD Treatment for Incarcerated Men and Women: WPP
Official title: PTSD Treatment for Incarcerated Men and Women: WPP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Group therapy
Incarcerated Individuals
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Partnership Program
First posted: 2022-06-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two therapy-intervention groups: CPT or active waitlit control group
Primary purpose: TREATMENT

Brief 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 populations (140 participants total).

Detailed description: Overall Study Objectives:

The primary objectives of this project include:

1. Determine the effectiveness of CPT in reducing PTSD symptom severity;
2. 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 8 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).

Eligibility criteria: Participants will be enrolled from the Department of Corrections trauma treatment waitlist who have been screened for:

* 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

Inclusion Criteria:

* 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
* no serious self-harm within past 6-months
* no disciplinary segregation tim in past 6-months
* have not participated in the previous CPT groups with UW project

Primary outcomes:
measure: Change in PTSD Checklist for DSM-5 (PCL-5) severity score
timeFrame: baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 weeks (three months post-treatment)
Secondary outcomes:
measure: Change in score on the Beck Depression Inventory 2 (BDI-II)
timeFrame: baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), and up to 12 weeks (one month post-treatment)
measure: Change in score on the Beck Anxiety Inventory (BAI)
timeFrame: baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 weeks (three months post-treatment)
measure: Percentage of participants endorsing 2 or higher on Q9 of BDI-II
timeFrame: baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 weeks (three months post-treatment)
measure: Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
timeFrame: Up to 7 weeks (by the end of the 12th session)
measure: Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
timeFrame: Up to 7 weeks (by the end of the 12th session)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Psychiatric Institute and Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael R Koenigs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.
citation: 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.
citation: 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.