Clinical trial NCT03029949: Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
Official title: Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Dizziness
Keywords: chronic dizziness
persistent postural-perceptual dizziness
acceptance and commitment therapy
behavior therapy
vestibular rehabilitation
Lead sponsor: Nagoya City University
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Handicap due to dizziness
timeFrame: Post-treatment and 1, 3, and 6 months after treatment (The time point of primary interest is 3 months after treatment.)
Secondary outcomes:
measure: Response
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Remission
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Frequency of dizziness-related symptoms
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Anxiety
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Depression
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Recovery process
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Health-related quality of life
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Valued living (progress, obstruction)
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Cognitive fusion
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
measure: Somatic symptom burden
timeFrame: Post-treatment and 1, 3, and 6 months after treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University
state: Aichi
Study officials:
affiliation: Nagoya City University
name: Masaki Kondo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: