Chronic DizzinessNCT03029949
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness
A study testing ACT with VR, self-treatment VR and clinical management in people with Chronic Dizziness, run by Nagoya City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Chronic Dizziness
- What is being tested?
- ACT with VR, self-treatment VR and clinical management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteJapan
- Study dates
- 25 Apr 2017to 31 Oct 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Dizziness
- Being tested
- ACT with VR, self-treatment VR, clinical management
- Keywords
- chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT with VRBehavioural
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 VRBehavioural
booklet written on vestibular rehabilitation for self-treatment
clinical managementOther
clinical management and pharmacotherapy as usual for chronic dizziness
| Study group | Role | What they receive |
|---|---|---|
| ACT with VR | Experimental | acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management Receives: Behavioral: ACT with VR; Other: clinical management |
| Self-treatment VR | Active comparator | self-treatment vestibular rehabilitation in addition to clinical management Receives: Behavioral: self-treatment VR; Other: clinical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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
Decrease in the total score of DHI equal to or more than 11
Measured: Post-treatment and 1, 3, and 6 months after treatment
Remission
The total score of DHI equal to or less than 14
Measured: Post-treatment and 1, 3, and 6 months after treatment
Frequency of dizziness-related symptoms
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.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Anxiety
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.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Depression
The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Recovery process
The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Health-related quality of life
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.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Valued living (progress, obstruction)
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.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Cognitive fusion
The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Somatic symptom burden
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.)
Measured: Post-treatment and 1, 3, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start25 Apr 2017
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masaki Kondo, Nagoya City University
- Investigators
- Masaki Kondo, MD, PhD, Principal investigator, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029949
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2017
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided