Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

• Sponsor: Nagoya City University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03029949
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Dizziness	Behavioral: ACT with VR; Behavioral: self-treatment VR; Other: clinical management	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Statisticians are blinded.
• Primary Purpose: Treatment
• Official Title: Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
• Actual Study Start Date: Apr 25, 2017
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACT with VR acceptance and commitment therapy with vestibular rehabilitation in addition to clinical management	Behavioral: 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; Other: clinical management; clinical management and pharmacotherapy as usual for chronic dizziness
Active Comparator: Self-treatment VR self-treatment vestibular rehabilitation in addition to clinical management	Behavioral: self-treatment VR; booklet written on vestibular rehabilitation for self-treatment; Other: clinical management; clinical management and pharmacotherapy as usual for chronic dizziness

Outcome Measures

Primary Outcome Measures

1. Handicap due to dizziness [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.)

Secondary Outcome Measures

1. Response [Post-treatment and 1, 3, and 6 months after treatment]

   Decrease in the total score of DHI equal to or more than 11

2. Remission [Post-treatment and 1, 3, and 6 months after treatment]

   The total score of DHI equal to or less than 14

3. Frequency of dizziness-related symptoms [Post-treatment and 1, 3, and 6 months after treatment]

   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.)

4. Anxiety [Post-treatment and 1, 3, and 6 months after treatment]

   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.)

5. Depression [Post-treatment and 1, 3, and 6 months after treatment]

   The depression subscale score of HADS (The HADS-depression scores range from 0 to 21 points. The higher the score, the worse.)

6. Recovery process [Post-treatment and 1, 3, and 6 months after treatment]

   The total score of Recovery Assessment Scale (RAS) (The RAS scores range from 24 to 120 points. The higher the score, the better.)

7. Health-related quality of life [Post-treatment and 1, 3, and 6 months after treatment]

   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.)

8. Valued living (progress, obstruction) [Post-treatment and 1, 3, and 6 months after treatment]

   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.)

9. Cognitive fusion [Post-treatment and 1, 3, and 6 months after treatment]

   The total score of Cognitive Fusion Questionnaire (CFQ) (The CFQ scores range from 7 to 49 points. The higher the score, the worse.)

10. Somatic symptom burden [Post-treatment and 1, 3, and 6 months after treatment]

    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.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University	Nagoya	Aichi	Japan	467-8601

Sponsors and Collaborators

• Nagoya City University

Investigators

• Principal Investigator: Masaki Kondo, MD, PhD, Nagoya City University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masaki Kondo, MD, PhD, Nagoya City University
• ClinicalTrials.gov Identifier: NCT03029949
• Other Study ID Numbers: 1
• First Posted: Jan 24, 2017
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Masaki Kondo, MD, PhD, Nagoya City University: chronic dizziness; persistent postural-perceptual dizziness; acceptance and commitment therapy; behavior therapy; vestibular rehabilitation
• Additional relevant MeSH terms: Vertigo; Dizziness

Study Results

No Results Posted as of Mar 3, 2021