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Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

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ClinicalTrials.gov Identifier: NCT03029949
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Masaki Kondo, Nagoya City University

Brief Summary:
The purpose of this study is to examine the effectiveness of acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management for chronic dizziness, in comparison with treatment-as-usual(TAU) which is self-treatment vestibular rehabilitation in addition to clinical management for chronic dizziness.

Condition or disease Intervention/treatment Phase
Chronic Dizziness Behavioral: ACT with VR Behavioral: self-treatment VR Other: clinical management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
Estimated Study Start Date : April 25, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT with VR
acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
Behavioral: ACT with VR
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

Other: clinical management
clinical management and pharmacotherapy as usual for chronic dizziness

Active Comparator: Self-treatment VR
self-treatment vestibular rehabilitation in addition to clinical management
Behavioral: self-treatment VR
booklet written on vestibular rehabilitation for self-treatment

Other: clinical management
clinical management and pharmacotherapy as usual for chronic dizziness




Primary Outcome Measures :
  1. Handicap due to dizziness [ Time Frame: 3 months after treatment ]
    The total score of Dizziness Handicap Inventory (DHI)


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 3 months after treatment ]
    Decrease in the total score of DHI equal to or more than 18

  2. Remission rate [ Time Frame: 3 months after treatment ]
    The total score of DHI equal to or less than 14

  3. Frequency of dizziness-related symptoms [ Time Frame: 3 months after treatment ]
    The total score of Vertigo Symptom Scale-short form (VSS-sf)

  4. Anxiety [ Time Frame: 3 months after treatment ]
    The anxiety subscale score of Hospital Anxiety and Depression Scale

  5. Depression [ Time Frame: 3 months after treatment ]
    The depression subscale score of Hospital Anxiety and Depression Scale

  6. Recovery process [ Time Frame: 3 months after treatment ]
    The total score of Recovery Assessment Scale

  7. Quality of life [ Time Frame: 3 months after treatment ]
    EQ-5D score

  8. Valued living (progress, obstruction) [ Time Frame: 3 months after treatment ]
    The each subscale score of Valuing Questionnaire

  9. Cognitive fusion [ Time Frame: 3 months after treatment ]
    The total score of Cognitive Fusion Questionnaire



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent postural-perceptual dizziness (diagnosed by ICD-11 beta version at Dec. 2016)
  • Existing handicap due to dizziness (DHI equal to or more than 16)
  • Written consent

Exclusion Criteria:

  • Central vertigo/dizziness/unsteadiness diagnosed by neuro-otologist
  • Vertigo/dizziness/unsteadiness explained by only organic cause or drug, diagnosed by neuro-otologist
  • Physical status inappropriate for psychotherapy or vestibular rehabilitation
  • Current psychiatric disorder other than anxiety disorders, somatic symptom disorder, or illness anxiety disorder (DSM-5), diagnosed by psychiatrist
  • History of schizophrenia or bipolar disorder diagnosed by psychiatrist
  • Increased risk of suicide or self-harm diagnosed by psychiatrist
  • Started or increased SSRI/Venlafaxine within 1 month before treatment
  • Any cognitive behavioral therapy or vestibular rehabilitation except this study
  • Otological surgery or device therapy for dizziness
  • Insufficient understanding of Japanese language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029949


Contacts
Contact: Masaki Kondo, MD, PhD +81-52-851-5511 kondo-masaki@umin.ac.jp

Locations
Japan
Nagoya City University Recruiting
Nagoya, Aichi, Japan, 467-8601
Contact: Masaki Kondo, MD, PhD         
Sponsors and Collaborators
Nagoya City University
Investigators
Principal Investigator: Masaki Kondo, MD, PhD Nagoya City University

Responsible Party: Masaki Kondo, MD, PhD, Nagoya City University
ClinicalTrials.gov Identifier: NCT03029949     History of Changes
Other Study ID Numbers: 1
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Masaki Kondo, Nagoya City University:
chronic dizziness
persistent postural-perceptual dizziness
acceptance and commitment therapy
behavior therapy
vestibular rehabilitation

Additional relevant MeSH terms:
Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases