Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
研究概览
简要总结
In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 18 and 55
- •Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity
- •Participants must be willing and able to provide informed consent.
排除标准
- •Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects.
- •People with an active eating disorder that requires treatment, but we will not exclude people who are in remission.
- •Current illicit or prescription drug abuse
- •Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded
- •No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable
研究组 & 干预措施
Active tVNS paired with 12 sessions of ERP
干预措施: tVNS (Device)
Sham tVNS paired with 12 sessions of ERP
干预措施: Sham (Device)
结局指标
主要结局
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
时间窗: Baseline up to 1 month post treatment
A test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms. The scale can also provide a subscale score for obsessions and compulsions (range 0-20) separately.
次要结局
未报告次要终点