<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/NCT03230006</url>
  </required_header>
  <id_info>
    <org_study_id>R01AA023676</org_study_id>
    <nct_id>NCT03230006</nct_id>
  </id_info>
  <brief_title>Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders</brief_title>
  <official_title>Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</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>
      Almost 18 million US adults have alcohol use disorders (AUD), with one third of these&#xD;
      individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD&#xD;
      imposes a high burden via healthcare costs and lost productivity. To date, existing treatment&#xD;
      approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is&#xD;
      a lack of adequate research to guide treatment decisions.&#xD;
&#xD;
      The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown&#xD;
      efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence&#xD;
      from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with&#xD;
      results from this study indicating a reduction from baseline in drinks consumed per day.&#xD;
      However, further evaluation of the UP for managing AUD/AXD is warranted.&#xD;
&#xD;
      In this clinical trial, the investigators will further assess the UP's effectiveness in&#xD;
      reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be&#xD;
      randomized to one of two conditions: 1) treatment with the UP or 2) treatment with&#xD;
      therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in&#xD;
      a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be&#xD;
      used to examine the effects of the UP on changes in brain activity in areas important to&#xD;
      regulation of emotional and reward processes implicated in excessive alcohol consumption.&#xD;
&#xD;
      The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1)&#xD;
      be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater&#xD;
      reductions in percent days heavy drinking, percent days of drinking per week, and alcohol&#xD;
      craving.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>
    <intervention_model_description>Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Number of Drinks Consumed Per Day</measure>
    <time_frame>Change from baseline following 16-week treatment</time_frame>
    <description>The Timeline Followback (TLFB) will be used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and will subsequently be administered at the beginning of each psychotherapy session and during the follow-up sessions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Unified Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur (Boswell et al., 2013; Carl et al., 2014; Sauer-Zavala et al., 2012). These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Take Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unified Protocol for Transdiagnostic Treatment of Emotional Disorders</intervention_name>
    <description>The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.</description>
    <arm_group_label>Unified Protocol</arm_group_label>
    <other_name>UP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Take Control</intervention_name>
    <description>TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.</description>
    <arm_group_label>Take Control</arm_group_label>
    <other_name>TC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. DSM-5 diagnosis of an alcohol use disorder (AUD)&#xD;
&#xD;
          2. DSM-5 diagnosis of Social Anxiety Disorder (SAD), Panic Disorder/Agoraphobia (PD/A),&#xD;
             Generalized Anxiety Disorder (GAD), and/or Obsessive Compulsive Disorder (OCD) as&#xD;
             determined by a clinician-administered diagnostic assessment using the Anxiety&#xD;
             Disorder Interview Schedule for DSM-5 (ADIS-5); and are rated as crossing the&#xD;
             threshold for a formal DSM-5 diagnosis by assignment of an ADIS clinical severity&#xD;
             rating (CSR) of 4 (definitely disturbing/disabling on the 0-8 CSR scale) or higher on&#xD;
             at least the principal diagnosis.&#xD;
&#xD;
          3. Adults 21 years old or older&#xD;
&#xD;
          4. Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption&#xD;
&#xD;
          5. Reported drinking an average of at least 15 standard drinks per week for males, or 8&#xD;
             for females occurring over a 28-consecutive day period during the 90 day-long time&#xD;
             window that preceded the screening session&#xD;
&#xD;
          6. Must be willing to discontinue any form of psychotherapy, except AA, that he or she&#xD;
             may be receiving for either anxiety or depression prior to screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. DSM-5 diagnosis of current major depressive disorder (with the exception of&#xD;
             substance-induced depressive disorder) that requires immediate treatment with&#xD;
             pharmacologic agents, bipolar disorder, schizophrenia, current bulimia/anorexia,&#xD;
             dementia, or other substance dependence, with the exception of nicotine, marijuana,&#xD;
             and caffeine dependence.&#xD;
&#xD;
          2. Presence of suicidal ideation or history of suicide attempts&#xD;
&#xD;
          3. Non-English speakers&#xD;
&#xD;
          4. Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions&#xD;
             within the past 5 years)&#xD;
&#xD;
          5. Contraindications to MRI scans&#xD;
&#xD;
          6. History of head injury with &gt;5-minute loss of consciousness&#xD;
&#xD;
          7. Pregnancy Note: Women of childbearing potential (not postmenopausal for at least one&#xD;
             year) will be required to provide a negative urine pregnancy test prior to each scan.&#xD;
&#xD;
          8. Implantation of anything containing magnetically sensitive material including metal&#xD;
             plates, aneurysm clips, and cardiac pacemakers, stents; history of sheet metal work,&#xD;
             claustrophobia&#xD;
&#xD;
          9. Cognitive impairment (MOCA&lt;21).&#xD;
&#xD;
         10. Serious medical illness or instability for which hospitalization may be likely within&#xD;
             the next year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Farchione, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Univeristy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Todd Farchione, PhD</last_name>
    <phone>617-353-9610</phone>
    <email>tfarchio@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David H Barlow, PhD</last_name>
    <phone>617-353-9610</phone>
    <email>dhbarlow@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston University, Charles River Campus</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Todd Farchione, PhD</last_name>
      <phone>617-353-9610</phone>
      <email>tfarchio@bu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Todd Farchione</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </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>Alcohol Drinking</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/NCT03230006
org study id: R01AA023676
nct id: NCT03230006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these
      individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD
      imposes a high burden via healthcare costs and lost productivity. To date, existing treatment
      approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is
      a lack of adequate research to guide treatment decisions.

      The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown
      efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence
      from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with
      results from this study indicating a reduction from baseline in drinks consumed per day.
      However, further evaluation of the UP for managing AUD/AXD is warranted.

      In this clinical trial, the investigators will further assess the UP's effectiveness in
      reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be
      randomized to one of two conditions: 1) treatment with the UP or 2) treatment with
      therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in
      a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be
      used to examine the effects of the UP on changes in brain activity in areas important to
      regulation of emotional and reward processes implicated in excessive alcohol consumption.

      The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1)
      be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater
      reductions in percent days heavy drinking, percent days of drinking per week, and alcohol
      craving.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Number of Drinks Consumed Per Day
time frame: Change from baseline following 16-week treatment
description: The Timeline Followback (TLFB) will be used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and will subsequently be administered at the beginning of each psychotherapy session and during the follow-up sessions.
arm group label: Unified Protocol
arm group type: Active Comparator
description: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur (Boswell et al., 2013; Carl et al., 2014; Sauer-Zavala et al., 2012). These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
arm group label: Take Control
arm group type: Placebo Comparator
description: TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
intervention type: Behavioral
intervention name: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
description: The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.
arm group label: Unified Protocol
other name: UP
intervention type: Behavioral
intervention name: Take Control
description: TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
arm group label: Take Control
other name: TC
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Todd Farchione, PhD
role: Principal Investigator
affiliation: Boston Univeristy
last name: Todd Farchione, PhD
phone: 617-353-9610
email: tfarchio@bu.edu
last name: David H Barlow, PhD
phone: 617-353-9610
email: dhbarlow@bu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Todd Farchione
investigator title: Research Associate Professor
mesh term: Alcoholism
mesh term: Anxiety Disorders
mesh term: Alcohol Drinking