- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029949
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
November 14, 2023 updated by: Masaki Kondo, Nagoya City University
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 group acceptance and commitment therapy with vestibular rehabilitation for chronic dizziness, in comparison with self-treatment vestibular rehabilitation in addition to clinical management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Masaki Kondo, MD, PhD
- Phone Number: +81-52-851-5511
- Email: kondo-masaki@umin.ac.jp
Study Locations
-
-
Aichi
-
Nagoya, Aichi, Japan, 467-8601
- Nagoya City University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACT with VR
acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
|
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
clinical management and pharmacotherapy as usual for chronic dizziness
|
Active Comparator: Self-treatment VR
self-treatment vestibular rehabilitation in addition to clinical management
|
clinical management and pharmacotherapy as usual for chronic dizziness
booklet written on vestibular rehabilitation for self-treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.)
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment (The time point of primary interest is 3 months after treatment.)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
Decrease in the total score of DHI equal to or more than 11
|
Post-treatment and 1, 3, and 6 months after treatment
|
Remission
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
The total score of DHI equal to or less than 14
|
Post-treatment and 1, 3, and 6 months after treatment
|
Frequency of dizziness-related symptoms
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Anxiety
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Depression
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points.
The higher the score, the worse.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Recovery process
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points.
The higher the score, the better.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Health-related quality of life
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Valued living (progress, obstruction)
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Cognitive fusion
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points.
The higher the score, the worse.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Somatic symptom burden
Time Frame: Post-treatment and 1, 3, and 6 months after treatment
|
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.)
|
Post-treatment and 1, 3, and 6 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Masaki Kondo, MD, PhD, Nagoya City University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2017
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
January 20, 2017
First Submitted That Met QC Criteria
January 20, 2017
First Posted (Estimated)
January 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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