<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/NCT02214667</url>
  </required_header>
  <id_info>
    <org_study_id>R34DA036791</org_study_id>
    <nct_id>NCT02214667</nct_id>
  </id_info>
  <brief_title>Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates</brief_title>
  <official_title>Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment adaptation and implementation study for adult jail inmates with co-occurring&#xD;
      substance use disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail&#xD;
      inmates with co-occurring substance use and mental health disorders and to evaluate the&#xD;
      feasibility of implementing the adapted interventions and associated research and&#xD;
      communication protocols.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to recruit enough participants&#xD;
  </why_stopped>
  <start_date type="Actual">May 21, 2015</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Study months 21 through 34</time_frame>
    <description>Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Adapted Interventions</measure>
    <time_frame>Study months 21 through 34</time_frame>
    <description>How successfully can the adapted interventions be implemented (Focus Group interviews)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity</measure>
    <time_frame>Study months 21 through 34</time_frame>
    <description>DDMI and IGT Adherence Forms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance use</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Addiction Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychiatric symptoms</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Brief Psychiatric Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health status</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service use</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Epidemiological Catchment Area Interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Externalizing behaviors</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Triarchic Psychopathy Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measure</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Heinrichs-Carpenter Quality of Life Scale, Plus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrest</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Self-report and official jail records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment preferences</measure>
    <time_frame>Study months 20 through 30</time_frame>
    <description>Visual analog ranking of 8 different aspects of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Co-occurring Mental and Substance Use Disorders</condition>
  <condition>Crime</condition>
  <condition>Criminogenic Thinking</condition>
  <condition>Implementation</condition>
  <condition>Adaptation</condition>
  <arm_group>
    <arm_group_label>DDMI-IGT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the experimental condition will receive adapted versions of dual-diagnosis motivational interviewing ([DDMI] one session before release from jail) and integrated group therapy ([IGT] 12 community-based sessions over a 2-month period).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dual-diagnosis motivational interviewing (DDMI)</intervention_name>
    <description>DDMI is an evidence-based adaptation to motivational interviewing. DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.</description>
    <arm_group_label>DDMI-IGT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated group therapy (IGT)</intervention_name>
    <description>IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.</description>
    <arm_group_label>DDMI-IGT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Jail and community-based behavioral health services</intervention_name>
    <description>Existing behavioral health service programs</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive&#xD;
             disorder not otherwise specified [NOS]; bipolar disorder I, II, or NOS; schizophrenia&#xD;
             spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief&#xD;
             psychotic disorder; delusional disorder; or psychotic disorder NOS);&#xD;
&#xD;
          -  (2) resident of Wake County and detained in The Jail;&#xD;
&#xD;
          -  (3) &gt;18 years of age; (4) able to speak/read English; and (5) able to provide informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard A Van Dorn, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RTI International</name>
      <address>
        <city>Research Triangle Park</city>
        <state>North Carolina</state>
        <zip>27709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>March 13, 2020</last_update_submitted>
  <last_update_submitted_qc>March 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Jail</keyword>
  <keyword>co-occurring disorders</keyword>
  <keyword>implementation</keyword>
  <keyword>acceptability</keyword>
  <keyword>feasibility</keyword>
  <keyword>fidelity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02214667
org study id: R34DA036791
nct id: NCT02214667
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Treatment adaptation and implementation study for adult jail inmates with co-occurring
      substance use disorders.
We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail
      inmates with co-occurring substance use and mental health disorders and to evaluate the
      feasibility of implementing the adapted interventions and associated research and
      communication protocols.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability
time frame: Study months 21 through 34
description: Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview
measure: Feasibility of Adapted Interventions
time frame: Study months 21 through 34
description: How successfully can the adapted interventions be implemented (Focus Group interviews)
measure: Fidelity
time frame: Study months 21 through 34
description: DDMI and IGT Adherence Forms
measure: Substance use
time frame: Study months 20 through 30
description: Addiction Severity Index
measure: Psychiatric symptoms
time frame: Study months 20 through 30
description: Brief Psychiatric Rating Scale
measure: Health status
time frame: Study months 20 through 30
description: SF-12
measure: Service use
time frame: Study months 20 through 30
description: Epidemiological Catchment Area Interview
measure: Externalizing behaviors
time frame: Study months 20 through 30
description: Triarchic Psychopathy Measure
measure: Quality of life measure
time frame: Study months 20 through 30
description: Heinrichs-Carpenter Quality of Life Scale, Plus
measure: Arrest
time frame: Study months 20 through 30
description: Self-report and official jail records
measure: Treatment preferences
time frame: Study months 20 through 30
description: Visual analog ranking of 8 different aspects of treatment
arm group label: DDMI-IGT
arm group type: Experimental
description: Subjects randomized to the experimental condition will receive adapted versions of dual-diagnosis motivational interviewing ([DDMI] one session before release from jail) and integrated group therapy ([IGT] 12 community-based sessions over a 2-month period).
arm group label: Usual care
arm group type: Active Comparator
description: Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.
intervention type: Behavioral
intervention name: Dual-diagnosis motivational interviewing (DDMI)
description: DDMI is an evidence-based adaptation to motivational interviewing. DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.
arm group label: DDMI-IGT
intervention type: Behavioral
intervention name: Integrated group therapy (IGT)
description: IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.
arm group label: DDMI-IGT
intervention type: Behavioral
intervention name: Jail and community-based behavioral health services
description: Existing behavioral health service programs
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Richard A Van Dorn, Ph.D.
role: Principal Investigator
affiliation: RTI International
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: Yes