xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06019767</url>
    </required_header>
    <id_info>
      <org_study_id>2023-1144</org_study_id>
      <secondary_id>Protocol Version 8/11/23</secondary_id>
      <secondary_id>SMPH/PSYCHIATRY/PSYCHIATRY</secondary_id>
      <nct_id>NCT06019767</nct_id>
    </id_info>
    <brief_title>Peer-led Trauma Therapy for Re-entry</brief_title>
    <official_title>Peer-led Trauma Therapy for Re-entry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Wisconsin, Madison</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the research is to learn more about how to treat PTSD for people directly&#xD;
        impacted by incarceration (i.e., have spent time in prison or jail). This research will help&#xD;
        identify if a PTSD treatment group that is used in community settings, and led by individuals&#xD;
        with lived experience, is helpful in reducing PTSD symptoms among people who have been&#xD;
        directly impacted by incarceration.&#xD;
  &#xD;
        Participants will complete an interview to determine whether they are experiencing PTSD, and&#xD;
        if so, will participate in a 6-week therapy group treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two community Certified Peer Specialists (CPSs) who have experienced incarceration and&#xD;
        re-entry from prison, and who have experienced trauma will be trained on delivering group&#xD;
        Cognitive Processing Therapy (CPT).&#xD;
  &#xD;
        Working with the Wisconsin Department of Health Services (DHS) and community organizations&#xD;
        serving formerly incarcerated individuals, researchers will screen individuals for PTSD&#xD;
        treatment need, and invite 24 eligible individuals to participate in group CPT co-led by one&#xD;
        of the trained CPSs and a trained community therapist or provider.&#xD;
  &#xD;
        Eligible participants who are enrolled in the study will be invited to complete a 6-week (12&#xD;
        sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-,&#xD;
        mid-, and post-treatment mental health surveys. Participants will also complete a&#xD;
        post-treatment focus group where they are asked about their experience in the therapy and to&#xD;
        provide feedback on the study as a whole.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility: Participation</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Will be measured as the percentage of invited, eligible individuals who elect to participate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility: Rate of retention</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Will be measured by percentage of participants who complete at least 9 of the 12 study sessions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility: Compliance through participation</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility: Compliance through homework</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Will be measured by percentage of participants completing homework assignments each week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility: Compliance through completing assessments</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist</measure>
      <time_frame>Study duration (up to 2 years)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in suicide and self-harm ideation</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant satisfaction</measure>
      <time_frame>One week post-treatment (up to 7 weeks)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PTSD symptom severity</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in depression symptom severity</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in trauma related thoughts and beliefs</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in aspects of hopelessness</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in substance use</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in anxiety symptom severity</measure>
      <time_frame>Baseline to end of follow-up (up to 4.5 months)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>PTSD</condition>
    <arm_group>
      <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Groups of 6-8 receive CPT to treat PTSD</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Processing Therapy</intervention_name>
      <description>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.</description>
      <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  completed a prison or jail sentence&#xD;
  &#xD;
            -  no current psychosis symptoms&#xD;
  &#xD;
            -  no active self-harm or active suicidal intent&#xD;
  &#xD;
            -  able and willing to participate in group therapy&#xD;
  &#xD;
            -  meet criteria for PTSD treatment need&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  current and active psychosis&#xD;
  &#xD;
            -  current and active self-harm and suicidality&#xD;
  &#xD;
            -  no PTSD diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Koenigs, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Wisconsin, Madison</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael Koenigs, PhD</last_name>
      <phone>608-263-1679</phone>
      <email>mrkoenigs@wisc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Wisconsin</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53705</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael Koenigs, PhD</last_name>
        <phone>608-263-1679</phone>
        <email>mrkoenigs@wisc.edu</email>
      </contact>
      <investigator>
        <last_name>Michael Koenigs, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Previously incarcerated</keyword>
    <keyword>Group therapy</keyword>
    <keyword>Cognitive Processing Therapy</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06019767
  org study id: 2023-1144
  secondary id: Protocol Version 8/11/23
  secondary id: SMPH/PSYCHIATRY/PSYCHIATRY
  nct id: NCT06019767
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility: Participation
  time frame: Study duration (up to 2 years)
  description: Will be measured as the percentage of invited, eligible individuals who elect to participate.
  measure: Feasibility: Rate of retention
  time frame: Study duration (up to 2 years)
  description: Will be measured by percentage of participants who complete at least 9 of the 12 study sessions
  measure: Feasibility: Compliance through participation
  time frame: Study duration (up to 2 years)
  description: Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.
  measure: Feasibility: Compliance through homework
  time frame: Study duration (up to 2 years)
  description: Will be measured by percentage of participants completing homework assignments each week.
  measure: Feasibility: Compliance through completing assessments
  time frame: Study duration (up to 2 years)
  description: Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.
  measure: Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
  time frame: Study duration (up to 2 years)
  description: Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.
  measure: Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
  time frame: Study duration (up to 2 years)
  description: 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.
  measure: Change in suicide and self-harm ideation
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  measure: Participant satisfaction
  time frame: One week post-treatment (up to 7 weeks)
  description: 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.
  measure: Change in PTSD symptom severity
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  measure: Change in depression symptom severity
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  measure: Change in trauma related thoughts and beliefs
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  measure: Change in aspects of hopelessness
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.
  measure: Change in substance use
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  measure: Change in anxiety symptom severity
  time frame: Baseline to end of follow-up (up to 4.5 months)
  description: 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.
  arm group label: Cognitive Processing Therapy (CPT)
  arm group type: Experimental
  description: Groups of 6-8 receive CPT to treat PTSD
  intervention type: Behavioral
  intervention name: Cognitive Processing Therapy
  description: 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.
  arm group label: Cognitive Processing Therapy (CPT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael Koenigs, PhD
  role: Principal Investigator
  affiliation: University of Wisconsin, Madison
  last name: Michael Koenigs, PhD
  phone: 608-263-1679
  email: mrkoenigs@wisc.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No