MedPath

Peer-led Trauma Therapy for Re-entry

Not Applicable
Recruiting
Conditions
PTSD
Interventions
Behavioral: Cognitive Processing Therapy
Registration Number
NCT06019767
Lead Sponsor
University of Wisconsin, Madison
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.

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 48 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 or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
72
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 alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cognitive Processing Therapy (CPT)Cognitive Processing TherapyGroups of 6-8 receive CPT to treat PTSD
Primary Outcome Measures
NameTimeMethod
Feasibility: Compliance through participationStudy duration (up to 2 years)

Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.

Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapistStudy 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.

Ratings from 0-5 by clinical supervisors on therapist adherence to five session elementsStudy 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.

Feasibility: Rate of retentionStudy duration (up to 2 years)

Will be measured by percentage of participants who complete at least 9 of the 12 study sessions

Feasibility: Compliance through completing assessmentsStudy duration (up to 2 years)

Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.

Participant satisfactionOne 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.

Feasibility: ParticipationStudy duration (up to 2 years)

Will be measured as the percentage of invited, eligible individuals who elect to participate.

Feasibility: Compliance through homeworkStudy duration (up to 2 years)

Will be measured by percentage of participants completing homework assignments each week.

Change in suicide and self-harm ideationBaseline 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.

Change in PTSD symptom severityBaseline 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
NameTimeMethod
Change in trauma related thoughts and beliefsBaseline 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.

Change in anxiety symptom severityBaseline 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.

Change in depression symptom severityBaseline 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.

Change in aspects of hopelessnessBaseline to end of follow-up (up to 4.5 months)

Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.

Change in substance useBaseline 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.

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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