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PTSD Treatment for Incarcerated Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891797
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

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:

  1. Establish the feasibility of group CPT delivery in male and female prisons with PTSD by examining participant retention in the 12-week course;
  2. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Cognitive Processing Therapy
12 sessions of group-based Cognitive Processing Therapy administered 1x/week for 90 minutes each session.
Other: Cognitive Processing Therapy
Group-based psychotherapy.
Other Name: CPT

No Intervention: Control
No treatment/treatment as usual. Participants will complete questionnaires at three time points with no intervention.



Primary Outcome Measures :
  1. 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.

  2. Eligibility [ Time Frame: 3 months ]
    Percentage of inmates who meet the full set of inclusion criteria.

  3. Participation [ Time Frame: 4 months ]
    Percentage of eligible inmates agreeing to participate in randomization into one of the two groups.

  4. Retention [ Time Frame: 12 weeks ]
    Percentage of inmates attending all 12 sessions.

  5. 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.

  6. 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.

  7. 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

  8. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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 to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM 5 criteria for current PTSD diagnosis
  • IQ greater than 70
  • Reading level of 5th grade or higher
  • No history of psychosis or dementia
  • Stable medication use (same medication for at least one month) if using medication
  • No scheduled transfer or release for at least 12 weeks (the duration of the intervention).

Exclusion Criteria:

  • Other vulnerable populations within the prison setting will not be eligible for participation, such as:

    • pregnant women
    • individuals who have English as a second language
    • those with visual or hearing impairments
    • individuals appearing to lack the capacity to provide informed consent

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): NCT03891797


Locations
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United States, Wisconsin
Fox Lake Correctional Institute
Fox Lake, Wisconsin, United States, 53933
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Michael Koenigs, PhD UW-Madison
Publications:
Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03891797    
Other Study ID Numbers: 2018-0630
A538900 ( Other Identifier: UW Madison )
SMPH/PSYCHIATRY/PSYCHIATRY ( Other Identifier: UW Madison )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Informed consent gives permission to share de-identified participant data (all primary and secondary outcome measures) with other UW-Madison researchers. Other data sharing is not currently approved.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No