Clinical trial NCT06019767: Peer-led Trauma Therapy for Re-entry
Official title: Peer-led Trauma Therapy for Re-entry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Previously incarcerated
Group therapy
Cognitive Processing Therapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids

Primary outcomes:
measure: Feasibility: Participation
timeFrame: Study duration (up to 2 years)
measure: Feasibility: Rate of retention
timeFrame: Study duration (up to 2 years)
measure: Feasibility: Compliance through participation
timeFrame: Study duration (up to 2 years)
measure: Feasibility: Compliance through homework
timeFrame: Study duration (up to 2 years)
measure: Feasibility: Compliance through completing assessments
timeFrame: Study duration (up to 2 years)
measure: Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
timeFrame: Study duration (up to 2 years)
measure: Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
timeFrame: Study duration (up to 2 years)
measure: Change in suicide and self-harm ideation
timeFrame: Baseline to end of follow-up (up to 4.5 months)
measure: Participant satisfaction
timeFrame: One week post-treatment (up to 7 weeks)
measure: Change in PTSD symptom severity
timeFrame: Baseline to end of follow-up (up to 4.5 months)
Secondary outcomes:
measure: Change in depression symptom severity
timeFrame: Baseline to end of follow-up (up to 4.5 months)
measure: Change in trauma related thoughts and beliefs
timeFrame: Baseline to end of follow-up (up to 4.5 months)
measure: Change in aspects of hopelessness
timeFrame: Baseline to end of follow-up (up to 4.5 months)
measure: Change in substance use
timeFrame: Baseline to end of follow-up (up to 4.5 months)
measure: Change in anxiety symptom severity
timeFrame: Baseline to end of follow-up (up to 4.5 months)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Koenigs, PhD
role: PRINCIPAL_INVESTIGATOR
References: