Clinical trial NCT05168267: PTSD Treatment for Incarcerated Men and Women: NIMH
Official title: PTSD Treatment for Incarcerated Men and Women: NIMH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Group therapy
Incarcerated Individuals
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-12-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are assigned to CPT therapy-intervention group.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
timeFrame: up to 6 weeks (by the end of 12th session)
measure: Change in Self-reported PTSD Symptoms (PCL-5)
timeFrame: baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)
measure: Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)
timeFrame: Post (1 week post-intervention, up to 13 weeks on study)
Secondary outcomes:
measure: Percentage of Individuals That Meet Study Inclusion Criteria
timeFrame: baseline (one week prior to intervention)
measure: Percentage of Eligible Individuals Enrolled in the Study
timeFrame: up to start of intervention
measure: Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)
timeFrame: By the end of final treatment session (up to 12 weeks)
measure: Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets
timeFrame: By the end of final treatment session (up to 12 weeks)
measure: Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor
timeFrame: By the end of final treatment session (up to 12 weeks)
measure: Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist
timeFrame: By the end of final treatment session (up to 12 weeks)
measure: Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)
timeFrame: post (one week post-intervention, up to 13 weeks on study)
measure: Reasons for Participant Discontinuation
timeFrame: Up to 3 month follow up (up to 25 weeks)
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.