Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

NCT ID: NCT03029949

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Dizziness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Statisticians are blinded.

Study Groups

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ACT with VR

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

Group Type EXPERIMENTAL

ACT with VR

Intervention Type 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

clinical management

Intervention Type OTHER

clinical management and pharmacotherapy as usual for chronic dizziness

Self-treatment VR

self-treatment vestibular rehabilitation in addition to clinical management

Group Type ACTIVE_COMPARATOR

self-treatment VR

Intervention Type BEHAVIORAL

booklet written on vestibular rehabilitation for self-treatment

clinical management

Intervention Type OTHER

clinical management and pharmacotherapy as usual for chronic dizziness

Interventions

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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

Intervention Type BEHAVIORAL

self-treatment VR

booklet written on vestibular rehabilitation for self-treatment

Intervention Type BEHAVIORAL

clinical management

clinical management and pharmacotherapy as usual for chronic dizziness

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya City University

OTHER

Sponsor Role lead

Responsible Party

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Masaki Kondo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masaki Kondo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nagoya City University

Locations

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Nagoya City University

Nagoya, Aichi-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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