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Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03029949
Enrollment
66
Registered
2017-01-24
Start date
2017-04-25
Completion date
2021-10-31
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Dizziness

Keywords

chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation

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.

Interventions

BEHAVIORALACT 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

BEHAVIORALself-treatment VR

booklet written on vestibular rehabilitation for self-treatment

clinical management and pharmacotherapy as usual for chronic dizziness

Sponsors

Nagoya City University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Statisticians are blinded.

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Handicap due to dizzinessPost-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

MeasureTime frameDescription
RemissionPost-treatment and 1, 3, and 6 months after treatmentThe total score of DHI equal to or less than 14
Frequency of dizziness-related symptomsPost-treatment and 1, 3, and 6 months after treatmentThe 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.)
AnxietyPost-treatment and 1, 3, and 6 months after treatmentThe 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.)
DepressionPost-treatment and 1, 3, and 6 months after treatmentThe depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)
ResponsePost-treatment and 1, 3, and 6 months after treatmentDecrease in the total score of DHI equal to or more than 11
Health-related quality of lifePost-treatment and 1, 3, and 6 months after treatmentThe 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)Post-treatment and 1, 3, and 6 months after treatmentThe 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 fusionPost-treatment and 1, 3, and 6 months after treatmentThe total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)
Somatic symptom burdenPost-treatment and 1, 3, and 6 months after treatmentThe total score of Somatic Symptom Scale-8 (SSS-8) (The SSS-8 scores range from 0 to 32. The higher the score, the worse.)
Recovery processPost-treatment and 1, 3, and 6 months after treatmentThe total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026