<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/NCT03300232</url>
  </required_header>
  <id_info>
    <org_study_id>PSYCH-2018-26640</org_study_id>
    <nct_id>NCT03300232</nct_id>
  </id_info>
  <brief_title>Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format</brief_title>
  <official_title>Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring&#xD;
      anxiety disorder (&quot;comorbidity&quot;), a condition that marks a high degree of treatment&#xD;
      resistance, severity and relapse risk in AUD treatment patients. The investigators&#xD;
      conceptualize comorbidity as a feed-forward system (&quot;vicious cycle&quot;, [VC]) of interacting&#xD;
      negative affect/stress, drinking motives/behavior, coping skills deficits, environmental&#xD;
      circumstances, and neurobiological adaptations. Based on this model, the investigators&#xD;
      developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system&#xD;
      at several key linkage points. In a recently completed randomized controlled trial (RCT), the&#xD;
      investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in&#xD;
      better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or&#xD;
      standard AUD treatment alone. With a number needed to treat (NNT) index of 8 (relative to&#xD;
      standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large&#xD;
      positive impact on AUD treatment. Unfortunately, several significant barriers related to the&#xD;
      resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential&#xD;
      and, hence, the impact of this otherwise effective treatment. Therefore, to maximize the&#xD;
      public health and scientific potential of the investigators work, the investigators propose&#xD;
      to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable&#xD;
      and economical dissemination of the VC-CBT while maintaining its established efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered&#xD;
      VC-CBT for delivery on an internet-based computer platform. This work will be done using a&#xD;
      standard iterative process for developing e-content in partnership with local technology&#xD;
      experts experienced in producing engaging and effective e-learning products. Approximately 5&#xD;
      patients will be employed in this phase. The second phase (Years 2 and 3) will be devoted to&#xD;
      a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT. The&#xD;
      investigators will recruit AUD treatment patients with co-occurring anxiety disorder to&#xD;
      receive the computer-delivered VC-CBT (50 patients). Participants will complete follow-up&#xD;
      assessments one and four months following treatment. Participants will rate user satisfaction&#xD;
      and will be evaluated on skill and knowledge acquisition as well as use of the tools in the&#xD;
      follow-up period. Success in the proposed work will serve as pilot data in support of a&#xD;
      rigorous randomized clinical trial. The proposed work aims to provide an easy and inexpensive&#xD;
      computer-delivered version of the VC-CBT that has comparable efficacy to the validated but&#xD;
      resource-intensive therapist-delivered version. Achieving this will enable the VC-CBT therapy&#xD;
      to benefit more AUD treatment patients and to be more easily studied by other investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2018</start_date>
  <completion_date type="Actual">July 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 2021</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>User ratings</measure>
    <time_frame>up to 4 days post-treatment</time_frame>
    <description>Likert scale ratings of understanding, engagement, and applicability to current problems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge Acquisition</measure>
    <time_frame>up to 4 days post-treatment</time_frame>
    <description>Multiple choice and True/False questions to assess knowledge communicated in program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skills Acquisition</measure>
    <time_frame>up to 4 days post-treatment</time_frame>
    <description>Skill demonstration rated by study staff for accuracy</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Panic Disorder</condition>
  <condition>Social Anxiety</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Computer-based VC-CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-based VC-CBT</intervention_name>
    <description>Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice</description>
    <arm_group_label>Computer-based VC-CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and Statistical Manual-IV diagnosis of panic disorder (with or without&#xD;
             agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past&#xD;
             30 days&#xD;
&#xD;
          -  Diagnostic and Statistical Manual-IV diagnosis of alcohol dependence within the last&#xD;
             30 days&#xD;
&#xD;
          -  inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence&#xD;
&#xD;
          -  alcohol use in the 30 days preceding the beginning of their Lodging Plus (LP)&#xD;
             treatment&#xD;
&#xD;
          -  willingness and ability to provide informed consent&#xD;
&#xD;
          -  minimum of a sixth grade English reading level (deemed necessary to complete study&#xD;
             materials); as determined by their being able to read and understand the consent form&#xD;
&#xD;
          -  familiarity with computer keyboarding as determined by history&#xD;
&#xD;
          -  lives within reasonable driving distance of the Twin Cities and ability to travel to&#xD;
             Fairview to allow for in-person follow-up interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active psychosis or mania in the three months preceding the study&#xD;
&#xD;
          -  Physical impairment (e.g., blindness, deafness) that interferes with study&#xD;
             participation based on self-report or as judged by PI or study physician&#xD;
&#xD;
          -  current significant suicide risk (i.e., intention and plan) as deemed by the PI and&#xD;
             study physician to be serious and ongoing&#xD;
&#xD;
          -  primary PTSD as determined by the Structured Clinical Interview for DSM (SCID)&#xD;
             interview&#xD;
&#xD;
          -  suspected cognitive impairment that interferes with study participation as informed by&#xD;
             the SCID interview or as judged by the PI or study physician&#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>Matt Kushner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Panic Disorder</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/NCT03300232
org study id: PSYCH-2018-26640
nct id: NCT03300232
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring
      anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment
      resistance, severity and relapse risk in AUD treatment patients. The investigators
      conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting
      negative affect/stress, drinking motives/behavior, coping skills deficits, environmental
      circumstances, and neurobiological adaptations. Based on this model, the investigators
      developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system
      at several key linkage points. In a recently completed randomized controlled trial (RCT), the
      investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in
      better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or
      standard AUD treatment alone. With a number needed to treat (NNT) index of 8 (relative to
      standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large
      positive impact on AUD treatment. Unfortunately, several significant barriers related to the
      resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential
      and, hence, the impact of this otherwise effective treatment. Therefore, to maximize the
      public health and scientific potential of the investigators work, the investigators propose
      to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable
      and economical dissemination of the VC-CBT while maintaining its established efficacy.
The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered
      VC-CBT for delivery on an internet-based computer platform. This work will be done using a
      standard iterative process for developing e-content in partnership with local technology
      experts experienced in producing engaging and effective e-learning products. Approximately 5
      patients will be employed in this phase. The second phase (Years 2 and 3) will be devoted to
      a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT. The
      investigators will recruit AUD treatment patients with co-occurring anxiety disorder to
      receive the computer-delivered VC-CBT (50 patients). Participants will complete follow-up
      assessments one and four months following treatment. Participants will rate user satisfaction
      and will be evaluated on skill and knowledge acquisition as well as use of the tools in the
      follow-up period. Success in the proposed work will serve as pilot data in support of a
      rigorous randomized clinical trial. The proposed work aims to provide an easy and inexpensive
      computer-delivered version of the VC-CBT that has comparable efficacy to the validated but
      resource-intensive therapist-delivered version. Achieving this will enable the VC-CBT therapy
      to benefit more AUD treatment patients and to be more easily studied by other investigators.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: User ratings
time frame: up to 4 days post-treatment
description: Likert scale ratings of understanding, engagement, and applicability to current problems
measure: Knowledge Acquisition
time frame: up to 4 days post-treatment
description: Multiple choice and True/False questions to assess knowledge communicated in program
measure: Skills Acquisition
time frame: up to 4 days post-treatment
description: Skill demonstration rated by study staff for accuracy
arm group label: Computer-based VC-CBT
arm group type: Experimental
description: Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
intervention type: Behavioral
intervention name: Computer-based VC-CBT
description: Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
arm group label: Computer-based VC-CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Matt Kushner, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Anxiety Disorders
mesh term: Panic Disorder