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PTSD Treatment for Incarcerated Men and Women: NIMH

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ClinicalTrials.gov Identifier: NCT05168267
Recruitment Status : Recruiting
First Posted : December 23, 2021
Last Update Posted : November 15, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Cognitive Processing Therapy Not Applicable

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. This assessment will take approximately 90 minutes. 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 10 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants are assigned to CPT therapy-intervention group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PTSD Treatment for Incarcerated Men and Women: NIMH
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Cognitive Processing Therapy (CPT) group
Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) 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.




Primary Outcome Measures :
  1. Percentage of participants that attend all 12 Cognitive Processing Therapy sessions [ Time Frame: up to 6 weeks (by the end of 12th session) ]
    Intervention feasibility measured primarily by participant retention

  2. Change in PTSD Checklist for DSM-5 (PCL-5) severity score [ Time Frame: baseline (one week prior to intervention), up to 3 weeks (mid-intervention), up to 7 weeks (one week post-intervention), and up to 18 weeks (one month 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

  3. Mean scores on the CSQ-8 (client satisfaction questionnaire) [ Time Frame: 7 weeks after intervention begins ]
    Client treatment acceptability and satisfaction is measured by mean scores on the CTQ-8


Secondary Outcome Measures :
  1. Change in score on the Beck Depression Inventory 2 (BDI-II) [ Time Frame: baseline (one week prior to intervention), up to 7 weeks (mid-intervention), up to 14 weeks (one week post-intervention), and up to 18 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) [ Time Frame: baseline (one week prior to intervention), up to 7 weeks (mid-intervention), up to 14 weeks (one week post-intervention), and up to 18 weeks (one month 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 individuals that meet study inclusion criteria [ Time Frame: up to 13 weeks (by the end of 12th session) ]
    Assesses for participant eligibility as secondary measure of intervention feasibility.

  4. Percentage of eligible individuals agreeing to participate in study [ Time Frame: up to 13 weeks (by the end of 12th session) ]
    Assesses for participant interest as secondary measure of intervention feasibility.

  5. Percentage of participants performing intervention activities during session (e.g., attending to and contributing to the discussion) [ Time Frame: up to 13 weeks (by the end of 12th session) ]
    Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.

  6. Percentage of inmates completing the homework assignment each week [ Time Frame: up to 13 weeks (by the end of 12th session) ]
    Assesses for participant compliance: willingness to complete homework assignments as secondary measure of intervention feasibility.

  7. Percentage of participants fully completing the pre-, mid-, and post-intervention assessment batteries [ Time Frame: baseline (one week prior to intervention), up to 7 weeks (mid-intervention), up to 14 weeks (one week post-intervention), and up to 18 weeks (one month post-treatment) ]
    Assesses for participant compliance: willingness to complete questionnaires at timepoints as secondary measure of intervention feasibility.

  8. Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements. [ Time Frame: up to 13 weeks (by the end of 12th session) ]
    Higher ratings indicate 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 will be videotaped and rated.

  9. Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist [ Time Frame: up to 13 weeks (by the end of 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 videotaped group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.

  10. Percentage of participants endorsing 2 or higher on Q9 of BDI-II [ Time Frame: baseline (one week prior to intervention), up to 7 weeks (mid-intervention), up to 14 weeks (one week post-intervention), and up to 18 weeks (one month 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. Assesses for participant safety as secondary measure of intervention feasibility.

  11. Reasons for participant discontinuation [ Time Frame: Up to 14 weeks ]
    We will collect information on participant dropout reasons to understand reasons for discontinuation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself
  • history of psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05168267


Contacts
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Contact: Michael R Koenigs, PhD (608) 263-1679 mrkoenigs@wisc.edu

Locations
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United States, Wisconsin
Psychiatric Institute and Clinic Recruiting
Madison, Wisconsin, United States, 53719
Contact: Michael R Koenigs, PhD    608-263-1679    mrkoenigs@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Michael R Koenigs, PhD University of Wisconsin, Madison
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05168267    
Other Study ID Numbers: 2018-0630: NIMH
R34MH118319 ( U.S. NIH Grant/Contract )
A538900 ( Other Identifier: UW Madison )
First Posted: December 23, 2021    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Group therapy
Incarcerated Individuals