Peer-led Trauma Therapy for Re-entry

PTSD Clinical Trial

Official title:

Peer-led Trauma Therapy for Re-entry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019767
• Other study ID #: 2023-1144
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Michael Koenigs, PhD
• Phone: 608-263-1679
• Email: mrkoenigs[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Participation	Will be measured as the percentage of invited, eligible individuals who elect to participate.	Study duration (up to 2 years)
Primary	Feasibility: Rate of retention	Will be measured by percentage of participants who complete at least 9 of the 12 study sessions	Study duration (up to 2 years)
Primary	Feasibility: Compliance through participation	Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.	Study duration (up to 2 years)
Primary	Feasibility: Compliance through homework	Will be measured by percentage of participants completing homework assignments each week.	Study duration (up to 2 years)
Primary	Feasibility: Compliance through completing assessments	Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.	Study duration (up to 2 years)
Primary	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 efficacy.	Study duration (up to 2 years)
Primary	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 supervisor. Assesses for therapist compliance as secondary measure of intervention efficacy.	Study duration (up to 2 years)
Primary	Change in suicide and self-harm ideation	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.	Baseline to end of follow-up (up to 4.5 months)
Primary	Participant satisfaction	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.	One week post-treatment (up to 7 weeks)
Primary	Change in PTSD symptom severity	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.	Baseline to end of follow-up (up to 4.5 months)
Secondary	Change in depression symptom severity	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.	Baseline to end of follow-up (up to 4.5 months)
Secondary	Change in trauma related thoughts and beliefs	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.	Baseline to end of follow-up (up to 4.5 months)
Secondary	Change in aspects of hopelessness	Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.	Baseline to end of follow-up (up to 4.5 months)
Secondary	Change in substance use	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.	Baseline to end of follow-up (up to 4.5 months)
Secondary	Change in anxiety symptom severity	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.	Baseline to end of follow-up (up to 4.5 months)