Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

Chronic Dizziness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029949
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2023
• Source: Nagoya City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Dizziness
• Dizziness
• Vertigo

Intervention

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
• self-treatment VR
booklet written on vestibular rehabilitation for self-treatment

Other:
• clinical management
clinical management and pharmacotherapy as usual for chronic dizziness

Locations

Country	Name	City	State
Japan	Nagoya City University	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response	Decrease in the total score of DHI equal to or more than 11	Post-treatment and 1, 3, and 6 months after treatment
Secondary	Remission	The total score of DHI equal to or less than 14	Post-treatment and 1, 3, and 6 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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