NCT03029949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

January 20, 2017

Last Update Submit

November 14, 2023

Conditions

Chronic Dizziness

Keywords

chronic dizzinesspersistent postural-perceptual dizzinessacceptance and commitment therapybehavior therapyvestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Response

    Post-treatment and 1, 3, and 6 months after treatment

  • Remission

    Post-treatment and 1, 3, and 6 months after treatment

  • Frequency of dizziness-related symptoms

    Post-treatment and 1, 3, and 6 months after treatment

  • Anxiety

    Post-treatment and 1, 3, and 6 months after treatment

  • Depression

    Post-treatment and 1, 3, and 6 months after treatment

  • +5 more secondary outcomes

Study Arms (2)

ACT with VR

EXPERIMENTAL

acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management

Behavioral: ACT with VROther: clinical management

Self-treatment VR

ACTIVE COMPARATOR

self-treatment vestibular rehabilitation in addition to clinical management

Behavioral: self-treatment VROther: clinical management

Interventions

ACT with VRBEHAVIORAL

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

ACT with VR
self-treatment VRBEHAVIORAL

booklet written on vestibular rehabilitation for self-treatment

Self-treatment VR
clinical managementOTHER

clinical management and pharmacotherapy as usual for chronic dizziness

ACT with VRSelf-treatment VR

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

Location

Study Officials

  • Masaki Kondo, MD, PhD

    Nagoya City University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statisticians are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

April 25, 2017

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

JP(1)