Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

Not Applicable

Completed

• Conditions: Chronic Dizziness
• Interventions: Behavioral: ACT with VR; Behavioral: self-treatment VR; Other: clinical management

• Registration Number: NCT03029949
• Lead Sponsor: Nagoya City University

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.

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Study Start: 2017-04-25
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT with VR	ACT with VR	acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
ACT with VR	clinical management	acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management
Self-treatment VR	clinical management	self-treatment vestibular rehabilitation in addition to clinical management
Self-treatment VR	self-treatment VR	self-treatment vestibular rehabilitation in addition to clinical management

Primary Outcome Measures

Name	Time	Method
Handicap due to dizziness	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.)

Secondary Outcome Measures

Name	Time	Method
Frequency of dizziness-related symptoms	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.)
Response	Post-treatment and 1, 3, and 6 months after treatment	Decrease in the total score of DHI equal to or more than 11
Remission	Post-treatment and 1, 3, and 6 months after treatment	The total score of DHI equal to or less than 14
Anxiety	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.)
Depression	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.)
Recovery process	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.)
Valued living (progress, obstruction)	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.)
Cognitive fusion	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.)
Health-related quality of life	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.)
Somatic symptom burden	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.)

Trial Locations

Locations (1)

Nagoya City University; 🇯🇵 Nagoya, Aichi, Japan