<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/NCT03029949</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03029949</nct_id>
  </id_info>
  <brief_title>Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness</brief_title>
  <official_title>Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nagoya City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nagoya City University</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>
      The purpose of this study is to examine the effectiveness of group acceptance and commitment&#xD;
      therapy with vestibular rehabilitation for chronic dizziness, in comparison with&#xD;
      self-treatment vestibular rehabilitation in addition to clinical management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine whether group acceptance and commitment therapy&#xD;
      combined with vestibular rehabilitation in addition to clinical management for patients with&#xD;
      persistent postural-perceptual dizziness is more effective than treatment-as-usual(TAU),&#xD;
      which is self-treatment vestibular rehabilitation in addition to clinical management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</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>
    <masking_description>Statisticians are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Handicap due to dizziness</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment (The time point of primary interest is 3 months after treatment.)</time_frame>
    <description>The total score of Dizziness Handicap Inventory (DHI) (The DHI scores range from 0 to 100 points. The higher the score, the greater the handicap.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>Decrease in the total score of DHI equal to or more than 11</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The total score of DHI equal to or less than 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of dizziness-related symptoms</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The total score of Vertigo Symptom Scale-short form (VSS-sf) (The VSS-sf scores range from 0 to 60 points. The higher the score, the worse.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The anxiety subscale score of Hospital Anxiety and Depression Scale (HADS) (The HADS-anxiety scores range from 0 to 21 points. The higher the score, the worse.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery process</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The score of EuroQOL 5 dimensions 5-level (EQ-5D-5L) (The EQ-5D-5L scores range from 0 to 1. The higher the score, the better.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valued living (progress, obstruction)</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The each subscale score of Valuing Questionnaire (VQ) (The scores for both VQ-progress and VQ-obstruction range from 0 to 30. The higher the VQ-progress score, the better; the higher the VQ-obstruction score, the worse.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive fusion</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic symptom burden</measure>
    <time_frame>Post-treatment and 1, 3, and 6 months after treatment</time_frame>
    <description>The total score of Somatic Symptom Scale-8 (SSS-8) (The SSS-8 scores range from 0 to 32. The higher the score, the worse.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Dizziness</condition>
  <arm_group>
    <arm_group_label>ACT with VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-treatment VR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>self-treatment vestibular rehabilitation in addition to clinical management</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACT with VR</intervention_name>
    <description>6 weekly 120-minute group sessions of acceptance and commitment therapy with vestibular rehabilitation, and brief (approximately 15 minute) individual follow-up sessions at 1 and 3 months after the group treatment</description>
    <arm_group_label>ACT with VR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-treatment VR</intervention_name>
    <description>booklet written on vestibular rehabilitation for self-treatment</description>
    <arm_group_label>Self-treatment VR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clinical management</intervention_name>
    <description>clinical management and pharmacotherapy as usual for chronic dizziness</description>
    <arm_group_label>ACT with VR</arm_group_label>
    <arm_group_label>Self-treatment VR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persistent postural-perceptual dizziness (diagnosed by the diagnostic guideline of&#xD;
             ICD-11 beta version at Dec. 2016)&#xD;
&#xD;
          -  Existing handicap due to dizziness (DHI equal to or more than 16)&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vertigo/dizziness/unsteadiness by organic brain diseases, diagnosed by neuro-otologist&#xD;
&#xD;
          -  Vertigo/dizziness/unsteadiness explained by only organic cause or drug, diagnosed by&#xD;
             neuro-otologist&#xD;
&#xD;
          -  Physical status inappropriate for psychotherapy or vestibular rehabilitation&#xD;
&#xD;
          -  Current psychiatric disorder other than anxiety disorders, somatic symptom disorder,&#xD;
             or illness anxiety disorder (DSM-5), diagnosed by psychiatrist&#xD;
&#xD;
          -  History of schizophrenia or bipolar disorder diagnosed by psychiatrist&#xD;
&#xD;
          -  Increased risk of suicide or self-harm diagnosed by psychiatrist&#xD;
&#xD;
          -  Started or increased SSRI/Venlafaxine within 1 month before treatment&#xD;
&#xD;
          -  Any cognitive behavioral therapy or vestibular rehabilitation except this study&#xD;
&#xD;
          -  Otological surgery or device therapy for dizziness&#xD;
&#xD;
          -  Insufficient understanding of the Japanese language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masaki Kondo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nagoya City University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Masaki Kondo, MD, PhD</last_name>
    <phone>+81-52-851-5511</phone>
    <email>kondo-masaki@umin.ac.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nagoya City University</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>467-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Masaki Kondo, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nagoya City University</investigator_affiliation>
    <investigator_full_name>Masaki Kondo</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>chronic dizziness</keyword>
  <keyword>persistent postural-perceptual dizziness</keyword>
  <keyword>acceptance and commitment therapy</keyword>
  <keyword>behavior therapy</keyword>
  <keyword>vestibular rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03029949
org study id: 1
nct id: NCT03029949
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of group acceptance and commitment
      therapy with vestibular rehabilitation for chronic dizziness, in comparison with
      self-treatment vestibular rehabilitation in addition to clinical management.
The purpose of this study is to examine whether group acceptance and commitment therapy
      combined with vestibular rehabilitation in addition to clinical management for patients with
      persistent postural-perceptual dizziness is more effective than treatment-as-usual(TAU),
      which is self-treatment vestibular rehabilitation in addition to clinical management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Statisticians are blinded.
measure: Handicap due to dizziness
time frame: Post-treatment and 1, 3, and 6 months after treatment (The time point of primary interest is 3 months after treatment.)
description: The total score of Dizziness Handicap Inventory (DHI) (The DHI scores range from 0 to 100 points. The higher the score, the greater the handicap.)
measure: Response
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: Decrease in the total score of DHI equal to or more than 11
measure: Remission
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The total score of DHI equal to or less than 14
measure: Frequency of dizziness-related symptoms
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The total score of Vertigo Symptom Scale-short form (VSS-sf) (The VSS-sf scores range from 0 to 60 points. The higher the score, the worse.)
measure: Anxiety
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The anxiety subscale score of Hospital Anxiety and Depression Scale (HADS) (The HADS-anxiety scores range from 0 to 21 points. The higher the score, the worse.)
measure: Depression
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)
measure: Recovery process
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)
measure: Health-related quality of life
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The score of EuroQOL 5 dimensions 5-level (EQ-5D-5L) (The EQ-5D-5L scores range from 0 to 1. The higher the score, the better.)
measure: Valued living (progress, obstruction)
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The each subscale score of Valuing Questionnaire (VQ) (The scores for both VQ-progress and VQ-obstruction range from 0 to 30. The higher the VQ-progress score, the better; the higher the VQ-obstruction score, the worse.)
measure: Cognitive fusion
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)
measure: Somatic symptom burden
time frame: Post-treatment and 1, 3, and 6 months after treatment
description: The total score of Somatic Symptom Scale-8 (SSS-8) (The SSS-8 scores range from 0 to 32. The higher the score, the worse.)
arm group label: ACT with VR
arm group type: Experimental
description: acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
arm group label: Self-treatment VR
arm group type: Active Comparator
description: self-treatment vestibular rehabilitation in addition to clinical management
intervention type: Behavioral
intervention name: ACT with VR
description: 6 weekly 120-minute group sessions of acceptance and commitment therapy with vestibular rehabilitation, and brief (approximately 15 minute) individual follow-up sessions at 1 and 3 months after the group treatment
arm group label: ACT with VR
intervention type: Behavioral
intervention name: self-treatment VR
description: booklet written on vestibular rehabilitation for self-treatment
arm group label: Self-treatment VR
intervention type: Other
intervention name: clinical management
description: clinical management and pharmacotherapy as usual for chronic dizziness
arm group label: ACT with VR
arm group label: Self-treatment VR
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
last name: Masaki Kondo, MD, PhD
role: Principal Investigator
affiliation: Nagoya City University
last name: Masaki Kondo, MD, PhD
phone: +81-52-851-5511
email: kondo-masaki@umin.ac.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Nagoya City University
investigator full name: Masaki Kondo
investigator title: MD, PhD
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: Undecided