Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial

Conditions
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Chronic Dizziness

Intervention / Treatment
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* Behavioral: ACT with VR
* Behavioral: self-treatment VR
* Other: clinical management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT with VR<br>acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management | Behavioral: ACT with VR<br>* 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<br>Other: clinical management<br>* clinical management and pharmacotherapy as usual for chronic dizziness<br>|
| Active Comparator: Self-treatment VR<br>self-treatment vestibular rehabilitation in addition to clinical management | Behavioral: self-treatment VR<br>* booklet written on vestibular rehabilitation for self-treatment<br>Other: clinical management<br>* clinical management and pharmacotherapy as usual for chronic dizziness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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 | Decrease in the total score of DHI equal to or more than 11 | Post-treatment and 1, 3, and 6 months after treatment | 
| Remission | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation