Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).
研究概览
简要总结
This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.
详细描述
Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.
This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
- •Strongly held OCRD-related concerns meeting BABS score criterion.
- •No recent change in psychopharmacological treatment, if any
- •Capacity to provide informed consent
排除标准
- •Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
- •Pregnant or nursing women
- •Active or recent substance use
结局指标
主要结局
change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).
时间窗: 1 hour
Changes in clinical insight will be rated using the BABS, a gold-standard measure for assessing multiple dimensions of clinical insight across psychiatric disorders. The BABS is a 24 point scale for which scores ≥13 suggest poor or absent insight.
次要结局
未报告次要终点
研究者
Peter J van Roessel, MD PhD
Clinical Assistant Professor, Dept. Psychiatry and Behavioral Sciences
Stanford University