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Peer-led Trauma Therapy for Re-entry

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06019767
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.

Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.


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

Detailed Description:

Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).

Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 24 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.

Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group where they are asked about their experience in the therapy and to provide feedback on the study as a whole.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peer-led Trauma Therapy for Re-entry
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Processing Therapy (CPT)
Groups of 6-8 receive CPT to treat PTSD
 Behavioral: Cognitive Processing Therapy
CPT is 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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility: Participation [ Time Frame: Study duration (up to 2 years) ]
    Will be measured as the percentage of invited, eligible individuals who elect to participate.

  2. Feasibility: Rate of retention [ Time Frame: Study duration (up to 2 years) ]
    Will be measured by percentage of participants who complete at least 9 of the 12 study sessions

  3. Feasibility: Compliance through participation [ Time Frame: Study duration (up to 2 years) ]
    Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.

  4. Feasibility: Compliance through homework [ Time Frame: Study duration (up to 2 years) ]
    Will be measured by percentage of participants completing homework assignments each week.

  5. Feasibility: Compliance through completing assessments [ Time Frame: Study duration (up to 2 years) ]
    Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.

  6. Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements [ Time Frame: Study duration (up to 2 years) ]
    Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.

  7. Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist [ Time Frame: Study duration (up to 2 years) ]
    Higher ratings indicate higher-quality session element (scores 1-7; 1=not satisfactory, 4= satisfactory, 7=excellent) by the clinical supervisor. Assesses for therapist compliance as secondary measure of intervention efficacy.

  8. Change in suicide and self-harm ideation [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Beck Depression Inventory-II (BDI-II), item 9. Participants will answer the item on a scale of 0-3, where a score of 2 or 3 indicates higher ideation.

  9. Participant satisfaction [ Time Frame: One week post-treatment (up to 7 weeks) ]
    Using the 8 item Client Satisfaction Questionnaire (CSQ-8), participants will rate their satisfaction with their experience. Scale ranges from 1-4, with total potential scores of 8 to 32 with higher scores indicating greater satisfaction.

  10. Change in PTSD symptom severity [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Using the PTSD Checklist for DSM-5 (PCL-5), which is a 20-item self-report measure, symptoms of PTSD will be assessed. Participants will answer items on a scale of 0-4, where 0=Not at all and 4=Extremely. Higher scores indicate higher symptom severity.


Secondary Outcome Measures :
  1. Change in depression symptom severity [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Beck Depression Inventory-II (BDI-II), which is a 21-item self-report measure to assess depression severity. Participants will answer items on a scale of 0-3, where lower scores indicate lower severity.

  2. Change in trauma related thoughts and beliefs [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Posttraumatic Cognitions Inventory (PTCI) is a 33-item measure of negative cognition about the world, negative self-related thoughts, and self-blame. Participants rate each item on a scale of 1-7, 1=totally disagree, 4=neutral, 7=totally agree. Higher scores indicate greater levels of trauma.

  3. Change in aspects of hopelessness [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.

  4. Change in substance use [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Tobacco, Alcohol, Prescription Medication, and other Substance Use Tool (TAPS) screens for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year, as well as the past 3 months.

  5. Change in anxiety symptom severity [ Time Frame: Baseline to end of follow-up (up to 4.5 months) ]
    Beck Anxiety Inventory (BAI), which is a 21-item self-report measure to assess anxiety severity. Participants will rate how much items bothered them as: Not at all; Mildly but it didn't bother me much; Moderately - it wasn't pleasant at times; or, Severely - it bothered me a lot. More symptoms that caused moderate or severe bother indicate higher severity of anxiety.


Eligibility Criteria
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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:

  • 18 years of age or older
  • completed a prison or jail sentence
  • no current psychosis symptoms
  • no active self-harm or active suicidal intent
  • able and willing to participate in group therapy
  • meet criteria for PTSD treatment need

Exclusion Criteria:

  • current and active psychosis
  • current and active self-harm and suicidality
  • no PTSD diagnosis
  • current substance use dependence (not including those used as prescribed for medical reasons) on cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT06019767


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

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Michael Koenigs, PhD    608-263-1679    mrkoenigs@wisc.edu   
Principal Investigator: Michael Koenigs, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Michael Koenigs, PhD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT06019767    
Other Study ID Numbers: 2023-1144
Protocol Version 8/11/23 ( Other Identifier: UW Madison )
SMPH/PSYCHIATRY/PSYCHIATRY ( Other Identifier: UW Madison )
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
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:
Previously incarcerated
Group therapy
Cognitive Processing Therapy