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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

January 20, 2017
January 24, 2017
April 25, 2017
April 25, 2017
March 31, 2021   (Final data collection date for primary outcome measure)
Handicap due to dizziness [ Time Frame: 3 months after treatment ]
The total score of Dizziness Handicap Inventory (DHI)
Same as current
Complete list of historical versions of study NCT03029949 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 3 months after treatment ]
    Decrease in the total score of DHI equal to or more than 18
  • Remission rate [ Time Frame: 3 months after treatment ]
    The total score of DHI equal to or less than 14
  • Frequency of dizziness-related symptoms [ Time Frame: 3 months after treatment ]
    The total score of Vertigo Symptom Scale-short form (VSS-sf)
  • Anxiety [ Time Frame: 3 months after treatment ]
    The anxiety subscale score of Hospital Anxiety and Depression Scale
  • Depression [ Time Frame: 3 months after treatment ]
    The depression subscale score of Hospital Anxiety and Depression Scale
  • Recovery process [ Time Frame: 3 months after treatment ]
    The total score of Recovery Assessment Scale
  • Quality of life [ Time Frame: 3 months after treatment ]
    EQ-5D score
  • Valued living (progress, obstruction) [ Time Frame: 3 months after treatment ]
    The each subscale score of Valuing Questionnaire
  • Cognitive fusion [ Time Frame: 3 months after treatment ]
    The total score of Cognitive Fusion Questionnaire
Same as current
Not Provided
Not Provided
 
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Dizziness
  • 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
  • Behavioral: self-treatment VR
    booklet written on vestibular rehabilitation for self-treatment
  • Other: clinical management
    clinical management and pharmacotherapy as usual for chronic dizziness
  • Experimental: ACT with VR
    acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
    Interventions:
    • Behavioral: ACT with VR
    • Other: clinical management
  • Active Comparator: Self-treatment VR
    self-treatment vestibular rehabilitation in addition to clinical management
    Interventions:
    • Behavioral: self-treatment VR
    • Other: clinical management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
March 31, 2021
March 31, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact: Masaki Kondo, MD, PhD +81-52-851-5511 kondo-masaki@umin.ac.jp
Japan
 
 
NCT03029949
1
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Masaki Kondo, Nagoya City University
Nagoya City University
Not Provided
Principal Investigator: Masaki Kondo, MD, PhD Nagoya City University
Nagoya City University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP