- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05168267
PTSD Treatment for Incarcerated Men and Women: NIMH
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael R Koenigs, PhD
- Phone Number: (608) 263-1679
- Email: mrkoenigs@wisc.edu
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53719
- Psychiatric Institute and Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants that attend all 12 Cognitive Processing Therapy sessions
Time Frame: up to 6 weeks (by the end of 12th session)
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Intervention feasibility measured primarily by participant retention
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up to 6 weeks (by the end of 12th session)
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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
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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)
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Mean scores on the CSQ-8 (client satisfaction questionnaire)
Time Frame: 7 weeks after intervention begins
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Client treatment acceptability and satisfaction is measured by mean scores on the CTQ-8
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7 weeks after intervention begins
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy
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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)
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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)
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Anxiety level measured by score on BAI (between 0 and 63; over 30 = severe anxiety); secondary measure of intervention efficacy
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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)
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Percentage of individuals that meet study inclusion criteria
Time Frame: up to 13 weeks (by the end of 12th session)
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Assesses for participant eligibility as secondary measure of intervention feasibility.
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up to 13 weeks (by the end of 12th session)
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Percentage of eligible individuals agreeing to participate in study
Time Frame: up to 13 weeks (by the end of 12th session)
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Assesses for participant interest as secondary measure of intervention feasibility.
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up to 13 weeks (by the end of 12th session)
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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)
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Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
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up to 13 weeks (by the end of 12th session)
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Percentage of inmates completing the homework assignment each week
Time Frame: up to 13 weeks (by the end of 12th session)
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Assesses for participant compliance: willingness to complete homework assignments as secondary measure of intervention feasibility.
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up to 13 weeks (by the end of 12th session)
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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)
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Assesses for participant compliance: willingness to complete questionnaires at timepoints as secondary measure of intervention feasibility.
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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)
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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)
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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.
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up to 13 weeks (by the end of 12th session)
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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)
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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.
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up to 13 weeks (by the end of 12th session)
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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)
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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.
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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)
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Reasons for participant discontinuation
Time Frame: Up to 14 weeks
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We will collect information on participant dropout reasons to understand reasons for discontinuation
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Up to 14 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael R Koenigs, PhD, University of Wisconsin, Madison
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018-0630: NIMH
- A538900 (Other Identifier: UW Madison)
- R34MH118319 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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