PTSD Treatment for Incarcerated Men and Women: WPP

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432817
Collaborator
Wisconsin Partnership Program (Other)
80
1
2
12
6.7

Study Details

Study Description

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 10 individuals for both CPT and Therapist-facilitated Support Group in both populations (i.e., 80 participants total; 40F/40M, four CPT groups of 10 (2 Female (F)/2 Male (M)); four Therapist-facilitated Support groups of 10 (2F/2M)). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Processing Therapy
  • Behavioral: Therapist-facilitated Support group
N/A

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 first complete the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) to ascertain current PTSD symptomology and diagnosis. This assessment will take approximately 90 minutes. Participants will then be assigned to the CPT or Therapist-facilitated Support groups. The CPT and Therapist-facilitated groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT and Therapist-facilitated group-members are also asked to complete weekly homework (approximately 12 hours total). Approximately 10 participants will be included in each CPT or therapist-facilitated session. Participants with PTSD will be randomized to the CPT or therapist-facilitated groups. Participants will be notified via institutional mail when they are starting CPT or therapist-facilitated support. Participants in either group 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 and therapist-facilitated support group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. During treatment week 3, CPT and therapist-facilitated support 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 7th therapy session. CPT and therapist-facilitated group members will then complete post-testing within one week after completing week 6 of treatment. One and three months after the treatment is completed, CPT and therapist-facilitated group members will complete follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. CPT and therapist-facilitated group members will be asked to complete 17 sessions in total (pre-, mid-, post-, one-month follow up-testing, three-month follow-up testing, and 12 treatment groups).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are assigned to one of two therapy-intervention groups: CPT or IPGT (active control group)Participants are assigned to one of two therapy-intervention groups: CPT or IPGT (active control group)
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PTSD Treatment for Incarcerated Men and Women: WPP
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Processing Therapy (CPT) group

Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 10 (40 total; 20F/20M) receive CPT to treat PTSD

Behavioral: Cognitive Processing Therapy
CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups.

Experimental: Therapist-facilitated Support group

Arm = Therapist-facilitated Support Group Group = 4 groups of 10 (40 total; 20F/20M) receive support as active control group for PTSD treatment

Behavioral: Therapist-facilitated Support group
Therapist-facilitated Support: group therapy oriented toward providing general support networks and communities of individuals with similar experiences. Sessions will also focus on establishing trust, open communication, and developing therapeutic alliance with group members and the therapist facilitator. Occurs over 12 sessions.

Outcome Measures

Primary Outcome Measures

  1. Change in PTSD Checklist for DSM-5 (PCL-5) severity score [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)]

    PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy

Secondary Outcome Measures

  1. Change in score on the Beck Depression Inventory 2 (BDI-II) [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)]

    Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy

  2. Change in score on the Beck Anxiety Inventory (BAI) [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)]

    Anxiety level measured by score on BAI (between 0 and 63; over 30 = severe anxiety); secondary measure of intervention efficacy

  3. Percentage of participants endorsing 2 or higher on Q9 of BDI-II [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)]

    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.

  4. Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements [Up to 7 weeks (by the end of the 12th session)]

    Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy. For each 12-session intervention, 2 sessions will be audiotaped and rated.

  5. Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist [Up to 7 weeks (by the end of the 12th session)]

    Higher ratings indicate higher-quality session element (scores 1-7;1="not satisfactory", 4="satisfactory", 7="excellent") by the clinical supervisors. Competence ratings will be collected for two audiotaped group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention efficacy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 CAPS-5 criteria for current PTSD diagnosis within 2months of enrollment

Exclusion Criteria:
  • scheduled transfer or release within 24 weeks (or during duration of intervention)

  • history of psychosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatric Institute and Clinic Madison Wisconsin United States 53719

Sponsors and Collaborators

  • University of Wisconsin, Madison
  • Wisconsin Partnership Program

Investigators

  • Principal Investigator: Michael R Koenigs, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT05432817
Other Study ID Numbers:
  • 2018-0630: WPP
  • A538900
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Wisconsin, Madison

Study Results

No Results Posted as of Jun 27, 2022