PTSD Treatment for Incarcerated Men and Women
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|ClinicalTrials.gov Identifier: NCT03891797|
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : November 15, 2019
There is a particular need for more effective treatments for post-traumatic stress disorder (PTSD) within the incarcerated population. The prevalence of trauma history and PTSD are markedly higher in jail and prison populations than in the general population, with estimates of current PTSD prevalence among prison inmates exceeding 20%, as opposed to 3-6% in the general population. Cognitive Processing Therapy (CPT) is a potentially promising PTSD treatment for the prison setting.
The primary objectives of this project include:
- Establish the feasibility of group CPT delivery in male and female prisons with PTSD by examining participant retention in the 12-week course;
- Obtain preliminary efficacy estimates for reducing PTSD symptom severity, as well as secondary symptoms associated with trauma, including depression, hopelessness, self-blame, and negative self-related thoughts.
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Other: Cognitive Processing Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PTSD Treatment for Incarcerated Men and Women|
|Actual Study Start Date :||March 5, 2019|
|Actual Primary Completion Date :||October 17, 2019|
|Actual Study Completion Date :||October 17, 2019|
Experimental: Cognitive Processing Therapy
12 sessions of group-based Cognitive Processing Therapy administered 1x/week for 90 minutes each session.
Other: Cognitive Processing Therapy
Other Name: CPT
No Intervention: Control
No treatment/treatment as usual. Participants will complete questionnaires at three time points with no intervention.
- PTSD-Checklist-5 (PCL-5) [ Time Frame: 4 months ]The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Participants rate on a 0 ("not at all") - 4 ("Extremely") scale how bothered they have been by PTSD symptoms in the last month. Total scores range from 0-80.
- Eligibility [ Time Frame: 3 months ]Percentage of inmates who meet the full set of inclusion criteria.
- Participation [ Time Frame: 4 months ]Percentage of eligible inmates agreeing to participate in randomization into one of the two groups.
- Retention [ Time Frame: 12 weeks ]Percentage of inmates attending all 12 sessions.
- Compliance [ Time Frame: 4 months ]Compliance will be measured in three ways: Percentage of retained inmates performing intervention activities during session (e.g., attending to and contributing to the discussion); the percentage of inmates completing the homework assignment each week; and the percentage of inmates fully completing the pre-, mid-, and post-intervention assessment batteries. All three measures of compliance will be reported individually. An overall metric of compliance will be calculated by averaging the three individual measures.
- Adherence [ Time Frame: 12 weeks ]Adherence will by measured by the presence or absence of five session elements (scores 0-5) by the clinical supervisors, as in previous CPT studies.
- Competence [ Time Frame: 12 weeks ]Ratings of the quality of session elements (scores 1-7; 1="not satisfactory", 4="satisfactory", 7="excellent") by the clinical supervisors, as in previous CPT studies
- Safety-Suicidal ideation item on the Beck Depression Inventory-II (BDI-II) [ Time Frame: 4 months ]The BDI-II is a 21-item self-report questionnaire assessing symptoms of depression in the last 2-weeks. Each item is on a 0-3 scale, with higher scores indicative of greater symptom severity. Scores range from 0-63.
- Posttraumatic Cognition Inventory (PCTI) [ Time Frame: 4 months ]The PCTI is a 33-item self-report questionnaire that assesses on a scale from 1(totally disagree) to 7 (totally agree) individuals agree with trauma-related maladaptive beliefs (e.g., "I am a weak person"). Scores range from 33-231.
- Beck Hopelessness Scale (BHS) [ Time Frame: 4 months ]The BHS is a 20-item self-report questionnaire assessing symptoms of hopelessness. Each item is a "true" or "false statement. Scores range from 0-20 depending on the number of items endorsed in the hopelessness direction.
- Beck Depression Inventory (BDI-II) [ Time Frame: 4 months ]The BDI-II is a 21-item self-report questionnaire assessing symptoms of depression in the last 2-weeks. Each item is on a 0-3 scale, with higher scores indicative of greater symptom severity. Scores range from 0-63.
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): NCT03891797
|United States, Wisconsin|
|Fox Lake Correctional Institute|
|Fox Lake, Wisconsin, United States, 53933|
|Principal Investigator:||Michael Koenigs, PhD||UW-Madison|