Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Handicap due to dizziness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Statisticians are blinded.
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Handicap due to dizziness
时间窗: 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.)
次要结局
- Frequency of dizziness-related symptoms(Post-treatment and 1, 3, and 6 months after treatment)
- Response(Post-treatment and 1, 3, and 6 months after treatment)
- Remission(Post-treatment and 1, 3, and 6 months after treatment)
- Anxiety(Post-treatment and 1, 3, and 6 months after treatment)
- Depression(Post-treatment and 1, 3, and 6 months after treatment)
- Recovery process(Post-treatment and 1, 3, and 6 months after treatment)
- Valued living (progress, obstruction)(Post-treatment and 1, 3, and 6 months after treatment)
- Cognitive fusion(Post-treatment and 1, 3, and 6 months after treatment)
- Health-related quality of life(Post-treatment and 1, 3, and 6 months after treatment)
- Somatic symptom burden(Post-treatment and 1, 3, and 6 months after treatment)
研究者
Masaki Kondo
MD, PhD
Nagoya City University