PTSD Treatment for Incarcerated Men and Women: NIMH

Study Overview
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Brief Summary
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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
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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).

Official Title
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PTSD Treatment for Incarcerated Men and Women: NIMH

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are assigned to CPT therapy-intervention group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Processing Therapy (CPT) group<br>Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) receive CPT to treat PTSD | Behavioral: Cognitive Processing Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants that attend all 12 Cognitive Processing Therapy sessions | Intervention feasibility measured primarily by participant retention | up to 6 weeks (by the end of 12th session) | 
| Change in PTSD Checklist for DSM-5 (PCL-5) severity score | PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy | 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) | 
| Mean scores on the CSQ-8 (client satisfaction questionnaire) | Client treatment acceptability and satisfaction is measured by mean scores on the CTQ-8 | 7 weeks after intervention begins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on the Beck Depression Inventory 2 (BDI-II) | Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy | 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) | 
| Change in score on the Beck Anxiety Inventory (BAI) | Anxiety level measured by score on BAI (between 0 and 63; over 30 = severe anxiety); secondary measure of intervention efficacy | 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) | 
| Percentage of individuals that meet study inclusion criteria | Assesses for participant eligibility as secondary measure of intervention feasibility. | up to 13 weeks (by the end of 12th session) | 
| Percentage of eligible individuals agreeing to participate in study | Assesses for participant interest as secondary measure of intervention feasibility. | up to 13 weeks (by the end of 12th session) | 
| Percentage of participants performing intervention activities during session (e.g., attending to and contributing to the discussion) | Assesses for participant compliance: participation during session as secondary measure of intervention feasibility. | up to 13 weeks (by the end of 12th session) | 
| Percentage of inmates completing the homework assignment each week | Assesses for participant compliance: willingness to complete homework assignments as secondary measure of intervention feasibility. | up to 13 weeks (by the end of 12th session) | 
| Percentage of participants fully completing the pre-, mid-, and post-intervention assessment batteries | Assesses for participant compliance: willingness to complete questionnaires at timepoints as secondary measure of intervention feasibility. | 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) | 
| Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements. | 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. | up to 13 weeks (by the end of 12th session) | 
| Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist | 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. | up to 13 weeks (by the end of 12th session) | 
| Percentage of participants endorsing 2 or higher on Q9 of BDI-II | 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. | 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) | 
| Reasons for participant discontinuation | We will collect information on participant dropout reasons to understand reasons for discontinuation | Up to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group therapy, Incarcerated Individuals