PTSD Treatment for Incarcerated Men and Women: NIMH

University of Wisconsin (UW)

Status

Completed

Conditions

PTSD

Treatments

Behavioral: Cognitive Processing Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05168267

A538900 (Other Identifier)

2018-0630: NIMH

R34MH118319 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Overall Study Objectives:

The primary objectives of this project include:

Establish the feasibility of group CPT delivery in male and female incarcerated populations with PTSD;
Establish the acceptability of group CPT delivery in male and female incarcerated populations with PTSD;
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).

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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