<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/NCT01685294</url>
  </required_header>
  <id_info>
    <org_study_id>1R01MH095230-01</org_study_id>
    <secondary_id>R01MH095230</secondary_id>
    <nct_id>NCT01685294</nct_id>
  </id_info>
  <brief_title>Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression</brief_title>
  <official_title>Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effects of a first-line treatment for major depressive disorder&#xD;
      (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment&#xD;
      in criminal justice settings by conducting a fully-powered randomized effectiveness study&#xD;
      that collects pilot implementation data, including cost-effectiveness data. Group IPT will be&#xD;
      compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD&#xD;
      from 4 institutions, allowing us to explore gender effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months</measure>
    <time_frame>3 Months from Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Suicidality at 3 Months</measure>
    <time_frame>3 Months from Baseline</time_frame>
    <description>Suicidality as measured by the Beck Scale for Suicide Ideation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in In-Prison Functioning at 3 Months</measure>
    <time_frame>3 Months from Baseline</time_frame>
    <description>In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months</measure>
    <time_frame>6 Months from Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Suicidality at 6 Months</measure>
    <time_frame>6 Months from Baseline</time_frame>
    <description>Suicidality as measured by the Beck Scale for Suicide Ideation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in In-Prison Functioning at 6 Months</measure>
    <time_frame>6 Months from Baseline</time_frame>
    <description>In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 months post-baseline</time_frame>
    <description>Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more &quot;good time.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Interpersonal Psychotherapy (IPT) for Depression + TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Group IPT for Depression + TAU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group IPT for Depression + TAU</intervention_name>
    <description>Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.</description>
    <arm_group_label>Group Interpersonal Psychotherapy (IPT) for Depression + TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder&#xD;
&#xD;
          -  Expectation of at least 6 months of incarceration at baseline interview&#xD;
&#xD;
          -  Incarcerated for at least 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime:&#xD;
&#xD;
               -  Bipolar disorder&#xD;
&#xD;
               -  Psychotic disorder&#xD;
&#xD;
          -  Are imminently suicidal&#xD;
&#xD;
          -  Cannot understand English well enough to understand the consent form or assessment&#xD;
             instruments when read aloud&#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>Jennifer E. Johnson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts Correctional Institute - Old Colony Correctional Center</name>
      <address>
        <city>Bridgewater</city>
        <state>Massachusetts</state>
        <zip>02324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Correctional Institution - Framingham</name>
      <address>
        <city>Framingham</city>
        <state>Massachusetts</state>
        <zip>01702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Middlesex Correctional Center</name>
      <address>
        <city>Framingham</city>
        <state>Massachusetts</state>
        <zip>01702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Correctional Institution - Norfolk</name>
      <address>
        <city>Norfolk</city>
        <state>Massachusetts</state>
        <zip>02056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adult Correctional Institution - Men's &amp; Women's Medium &amp; Minimum Security Facilities</name>
      <address>
        <city>Cranston</city>
        <state>Rhode Island</state>
        <zip>02920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>January 12, 2016</last_update_submitted>
  <last_update_submitted_qc>January 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Dr. Jennifer Johnson</investigator_full_name>
    <investigator_title>Associate Professor (Research), Department of Psychiatry and Human Behavior</investigator_title>
  </responsible_party>
  <keyword>Major Depressive Disorder (MDD)</keyword>
  <keyword>Suicidality</keyword>
  <keyword>Incarcerated Populations</keyword>
  <keyword>Prisons</keyword>
  <keyword>Interpersonal Psychotherapy (IPT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01685294
org study id: 1R01MH095230-01
secondary id: R01MH095230
nct id: NCT01685294
lead sponsor: 
collaborator: 
has dmc: Yes
This study will examine the effects of a first-line treatment for major depressive disorder
      (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.
The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment
      in criminal justice settings by conducting a fully-powered randomized effectiveness study
      that collects pilot implementation data, including cost-effectiveness data. Group IPT will be
      compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD
      from 4 institutions, allowing us to explore gender effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
time frame: 3 Months from Baseline
measure: Change from Baseline in Suicidality at 3 Months
time frame: 3 Months from Baseline
description: Suicidality as measured by the Beck Scale for Suicide Ideation.
measure: Change from Baseline in In-Prison Functioning at 3 Months
time frame: 3 Months from Baseline
description: In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
measure: Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
time frame: 6 Months from Baseline
measure: Change from Baseline in Suicidality at 6 Months
time frame: 6 Months from Baseline
description: Suicidality as measured by the Beck Scale for Suicide Ideation.
measure: Change from Baseline in In-Prison Functioning at 6 Months
time frame: 6 Months from Baseline
description: In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
measure: Cost-effectiveness
time frame: 6 months post-baseline
description: Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more "good time."
arm group label: Treatment as Usual (TAU)
arm group type: No Intervention
description: Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.
arm group label: Group Interpersonal Psychotherapy (IPT) for Depression + TAU
arm group type: Experimental
description: Participants will receive Group IPT for Depression + TAU.
intervention type: Behavioral
intervention name: Group IPT for Depression + TAU
description: Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.
arm group label: Group Interpersonal Psychotherapy (IPT) for Depression + TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer E. Johnson, Ph.D.
role: Principal Investigator
affiliation: Brown University
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Dr. Jennifer Johnson
investigator title: Associate Professor (Research), Department of Psychiatry and Human Behavior
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major