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Completed

NCT Number: NCT03029949

Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

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.

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Key information

Conditions

Chronic Dizziness

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT with VR

Behavioral

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

Behavioral

booklet written on vestibular rehabilitation for self-treatment

Clinical Management

Other

clinical management and pharmacotherapy as usual for chronic dizziness

Primary outcomes

  1. 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.)

Secondary outcomes

  1. 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

  2. Remission

    Time frame: Post-treatment and 1, 3, and 6 months after treatment

    The total score of DHI equal to or less than 14

  3. 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.)

  4. 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.)

  5. 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.)

  6. 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.)

  7. 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.)

  8. 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.)

  9. 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.)

  10. 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.)

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2017
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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