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
- Are there results?
- None posted in the registry
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
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03029949
- Acronym / sponsor ID
- 1
- Conditions
- Chronic Dizziness
- Keywords
- chronic dizziness, persistent postural-perceptual dizziness, acceptance and commitment therapy, behavior therapy, vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT with VR | Experimental | Behavioral: ACT with VR, Other: clinical managementacceptance and commitment therapy with vestibular rehabilitation in addition to clinical management |
| Self-treatment VR | Active comparator | Behavioral: self-treatment VR, Other: clinical managementself-treatment vestibular rehabilitation in addition to clinical management |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT with VR6 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 | Behavioural | ACT with VR |
| self-treatment VRbooklet written on vestibular rehabilitation for self-treatment | Behavioural | Self-treatment VR |
| clinical managementclinical management and pharmacotherapy as usual for chronic dizziness | Other | ACT with VR, Self-treatment VR |
Primary outcome
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.)
10 secondary outcomes
Response
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Remission
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Frequency of dizziness-related symptoms
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Anxiety
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Depression
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Recovery process
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Health-related quality of life
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Valued living (progress, obstruction)
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Cognitive fusion
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Somatic symptom burden
Time frame: Post-treatment and 1, 3, and 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaki Kondo, MD, PhD principal investigator
Nagoya City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.