<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/NCT03820973</url>
  </required_header>
  <id_info>
    <org_study_id>H-44258</org_study_id>
    <nct_id>NCT03820973</nct_id>
  </id_info>
  <brief_title>Brief Cognitive Behavioral Therapy for Anxiety</brief_title>
  <official_title>Development and Pilot Testing of Video-based Deliver of Brief Cognitive Behavioral Therapy for Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael E. DeBakey VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Michael E. DeBakey VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 proposed clinical intervention is a modular skills-based intervention for flexible&#xD;
      delivery of care, measurement-based care practices, and integration of exposure strategies&#xD;
      critical for anxiety symptom reduction. Notably, the treatment targets anxiety symptoms&#xD;
      rather than diagnoses to improve use in PCMHI and CBOC settings. The pilot study will develop&#xD;
      and conduct preliminary testing of bCBT for anxiety using Veterans Affairs (VA) Video Connect&#xD;
      to Home (VVC-H) to deliver care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety disorders are identified in over 30% of primary care patients and are associated with&#xD;
      substantial functional impairment, poor health-related quality of life, and suicide; however,&#xD;
      rates of treatment are low. In contrast to advances in improving treatment of depression and&#xD;
      posttraumatic stress disorder in VA, far less attention has been given to anxiety disorders.&#xD;
      In the absence of VA clinical practice guidelines for anxiety disorders, evidence-based&#xD;
      treatment practices are unstandardized in VA primary care and Community Based Outpatient&#xD;
      Clinics (CBOCs). Cognitive behavioral therapy (CBT) is an evidence-based intervention for the&#xD;
      anxiety disorders but was developed for use in specialty mental health settings and often&#xD;
      targets individual anxiety disorders (e.g.generalized anxiety, panic, and social phobia) with&#xD;
      diagnosis-specific treatment packages. These interventions are not practical for primary care&#xD;
      and CBOC settings where treatment must be brief and focused on reduction of anxiety symptoms&#xD;
      rather than targeted anxiety diagnoses. Further complicating the delivery of CBT for anxiety&#xD;
      disorders is that repeated exposure to feared cues is considered a critical component of CBT&#xD;
      for anxiety but is rarely used in these settings. Providers within VA currently have no&#xD;
      standardized options for delivering brief evidence-based psychotherapy for Veterans with&#xD;
      anxiety. Although Primary Care Mental Health Integration (PCMHI) and CBOCs increase access to&#xD;
      mental health services, VA recognizes the need to deliver mental health services using video&#xD;
      to home technology to increase access, decrease barriers (i.e., geographic distance,&#xD;
      transportation, travel time, stigma, child care) and provide more Veteran-centric care. VA is&#xD;
      pioneering implementation of VA Video Connect to Home (VVC-H) technology in specialty mental&#xD;
      health clinics, but VVC-H continues to be rarely used and little is known about the&#xD;
      implementation potential of VVC-H to improve psychotherapy access and outcomes in primary&#xD;
      care and CBOC settings. In summary, VA needs a flexible evidence-based approach for anxiety&#xD;
      that fits within primary care and CBOC settings and offers innovative delivery strategies to&#xD;
      increase access to care. Although treatment in PCMHI and CBOC settings must be time-limited,&#xD;
      it must also be highly effective. The investigators have developed robust brief CBT (bCBT)&#xD;
      interventions and provider support programs for depression and is now seeking to address&#xD;
      anxiety using a similar approach. The proposed clinical intervention will use&#xD;
      state-of-the-art practices including delivery of services via VVC-H. This open trial seeks to&#xD;
      recruit 12 Veterans who have significant anxiety symptoms according to the GAD-7 (standard&#xD;
      assessment tool for VA clinical settings). Veterans will be recruited from the Michael E.&#xD;
      DeBakey VAMC primary care clinic and affiliated Community Based Outpatient Clinics (CBOCs).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time</measure>
    <time_frame>Baseline, and 3-Months</time_frame>
    <description>scale used to measure anxiety, scores range from 0 to 21, where higher scores equal higher levels of anxiety.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Brief CBT for Anxiety</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Brief Cognitive Behavioral Therapy for Anxiety (bCBT). Sessions with clinicians will be provided via VA Video Connect to Home (VVC-H). Participants will have the option to select from a list of skills to tailor to his/her preferences. Participants will be able to receive up to 9 total sessions and generally last 30 to 40 minutes. For the purpose of this study, treatment duration will be limited to 3 months to ensure standardization of study outcome measures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief CBT for Anxiety</intervention_name>
    <description>All participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts.</description>
    <arm_group_label>Brief CBT for Anxiety</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Veteran participants: The sample will include Veterans who:&#xD;
&#xD;
          1. receive care at the Houston VA and surrounding area CBOCs,&#xD;
&#xD;
          2. have documentation in the medical chart of an anxiety disorder or anxiety-related&#xD;
             problems, and&#xD;
&#xD;
          3. report clinically significant symptoms of anxiety, defined as a score of 10 or greater&#xD;
             on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Veteran participants will be excluded for factors that would render bCBT inappropriate,&#xD;
        including:&#xD;
&#xD;
          1. cognitive impairment;&#xD;
&#xD;
          2. presence of bipolar, psychotic or substance use disorders, and&#xD;
&#xD;
          3. Veteran is currently receiving psychotherapy for anxiety. If receiving medications&#xD;
             that target anxiety Veterans WILL NOT be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Cully, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michael E. DeBakey VAMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michael E. DeBakey VAMC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michael E. DeBakey VA Medical Center</investigator_affiliation>
    <investigator_full_name>Jeffrey Cully</investigator_full_name>
    <investigator_title>Clinicial Research Psychologist</investigator_title>
  </responsible_party>
  <keyword>brief Cognitive Behavioral Therapy</keyword>
  <keyword>VA Video Connect to home</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03820973
org study id: H-44258
nct id: NCT03820973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed clinical intervention is a modular skills-based intervention for flexible
      delivery of care, measurement-based care practices, and integration of exposure strategies
      critical for anxiety symptom reduction. Notably, the treatment targets anxiety symptoms
      rather than diagnoses to improve use in PCMHI and CBOC settings. The pilot study will develop
      and conduct preliminary testing of bCBT for anxiety using Veterans Affairs (VA) Video Connect
      to Home (VVC-H) to deliver care.
Anxiety disorders are identified in over 30% of primary care patients and are associated with
      substantial functional impairment, poor health-related quality of life, and suicide; however,
      rates of treatment are low. In contrast to advances in improving treatment of depression and
      posttraumatic stress disorder in VA, far less attention has been given to anxiety disorders.
      In the absence of VA clinical practice guidelines for anxiety disorders, evidence-based
      treatment practices are unstandardized in VA primary care and Community Based Outpatient
      Clinics (CBOCs). Cognitive behavioral therapy (CBT) is an evidence-based intervention for the
      anxiety disorders but was developed for use in specialty mental health settings and often
      targets individual anxiety disorders (e.g.generalized anxiety, panic, and social phobia) with
      diagnosis-specific treatment packages. These interventions are not practical for primary care
      and CBOC settings where treatment must be brief and focused on reduction of anxiety symptoms
      rather than targeted anxiety diagnoses. Further complicating the delivery of CBT for anxiety
      disorders is that repeated exposure to feared cues is considered a critical component of CBT
      for anxiety but is rarely used in these settings. Providers within VA currently have no
      standardized options for delivering brief evidence-based psychotherapy for Veterans with
      anxiety. Although Primary Care Mental Health Integration (PCMHI) and CBOCs increase access to
      mental health services, VA recognizes the need to deliver mental health services using video
      to home technology to increase access, decrease barriers (i.e., geographic distance,
      transportation, travel time, stigma, child care) and provide more Veteran-centric care. VA is
      pioneering implementation of VA Video Connect to Home (VVC-H) technology in specialty mental
      health clinics, but VVC-H continues to be rarely used and little is known about the
      implementation potential of VVC-H to improve psychotherapy access and outcomes in primary
      care and CBOC settings. In summary, VA needs a flexible evidence-based approach for anxiety
      that fits within primary care and CBOC settings and offers innovative delivery strategies to
      increase access to care. Although treatment in PCMHI and CBOC settings must be time-limited,
      it must also be highly effective. The investigators have developed robust brief CBT (bCBT)
      interventions and provider support programs for depression and is now seeking to address
      anxiety using a similar approach. The proposed clinical intervention will use
      state-of-the-art practices including delivery of services via VVC-H. This open trial seeks to
      recruit 12 Veterans who have significant anxiety symptoms according to the GAD-7 (standard
      assessment tool for VA clinical settings). Veterans will be recruited from the Michael E.
      DeBakey VAMC primary care clinic and affiliated Community Based Outpatient Clinics (CBOCs).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Generalized Anxiety Disorder - 7 item scale - looking at change in scores over time
time frame: Baseline, and 3-Months
description: scale used to measure anxiety, scores range from 0 to 21, where higher scores equal higher levels of anxiety.
arm group label: Brief CBT for Anxiety
arm group type: Experimental
description: Participants will receive Brief Cognitive Behavioral Therapy for Anxiety (bCBT). Sessions with clinicians will be provided via VA Video Connect to Home (VVC-H). Participants will have the option to select from a list of skills to tailor to his/her preferences. Participants will be able to receive up to 9 total sessions and generally last 30 to 40 minutes. For the purpose of this study, treatment duration will be limited to 3 months to ensure standardization of study outcome measures.
intervention type: Behavioral
intervention name: Brief CBT for Anxiety
description: All participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts.
arm group label: Brief CBT for Anxiety
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jeffrey Cully, PhD
role: Principal Investigator
affiliation: Michael E. DeBakey VAMC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Michael E. DeBakey VA Medical Center
investigator full name: Jeffrey Cully
investigator title: Clinicial Research Psychologist
mesh term: Anxiety Disorders
sharing ipd: No