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Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

Primary Purpose

Chronic Dizziness

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ACT with VR
self-treatment VR
clinical management
Sponsored by
Nagoya City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Dizziness focused on measuring chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Vertigo/dizziness/unsteadiness by organic brain diseases, 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 the Japanese language

Sites / Locations

  • Nagoya City UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT with VR

Self-treatment VR

Arm Description

acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management

self-treatment vestibular rehabilitation in addition to clinical management

Outcomes

Primary Outcome Measures

Handicap due to dizziness
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.)

Secondary Outcome Measures

Response
Decrease in the total score of DHI equal to or more than 11
Remission
The total score of DHI equal to or less than 14
Frequency of dizziness-related symptoms
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.)
Anxiety
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.)
Depression
The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)
Recovery process
The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)
Health-related quality of life
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.)
Valued living (progress, obstruction)
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.)
Cognitive fusion
The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)
Somatic symptom burden
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.)

Full Information

First Posted
January 20, 2017
Last Updated
March 1, 2021
Sponsor
Nagoya City University
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1. Study Identification

Unique Protocol Identification Number
NCT03029949
Brief Title
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
Official Title
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya City University

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Dizziness
Keywords
chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Statisticians are blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT with VR
Arm Type
Experimental
Arm Description
acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
Arm Title
Self-treatment VR
Arm Type
Active Comparator
Arm Description
self-treatment vestibular rehabilitation in addition to clinical management
Intervention Type
Behavioral
Intervention Name(s)
ACT with VR
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
self-treatment VR
Intervention Description
booklet written on vestibular rehabilitation for self-treatment
Intervention Type
Other
Intervention Name(s)
clinical management
Intervention Description
clinical management and pharmacotherapy as usual for chronic dizziness
Primary Outcome Measure Information:
Title
Handicap due to dizziness
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment (The time point of primary interest is 3 months after treatment.)
Secondary Outcome Measure Information:
Title
Response
Description
Decrease in the total score of DHI equal to or more than 11
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Remission
Description
The total score of DHI equal to or less than 14
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Frequency of dizziness-related symptoms
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Anxiety
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Depression
Description
The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Recovery process
Description
The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Health-related quality of life
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Valued living (progress, obstruction)
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Cognitive fusion
Description
The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment
Title
Somatic symptom burden
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.)
Time Frame
Post-treatment and 1, 3, and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persistent postural-perceptual dizziness (diagnosed by the diagnostic guideline of ICD-11 beta version at Dec. 2016) Existing handicap due to dizziness (DHI equal to or more than 16) Written consent Exclusion Criteria: Vertigo/dizziness/unsteadiness by organic brain diseases, 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 the Japanese language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masaki Kondo, MD, PhD
Phone
+81-52-851-5511
Email
kondo-masaki@umin.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaki Kondo, MD, PhD
Organizational Affiliation
Nagoya City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya City University
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Kondo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

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