NCT05964998撤回不适用
Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Quick Inventory of Depressive Symptomology from admission to discharge
研究概览
简要总结
This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Primary diagnosis of Obsessive-Compulsive Disorder (OCD)
- •Resident of state of Wisconsin
- •Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI
- •Ability to communicate effectively using written and spoken English
排除标准
- •Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
- •Currently taking medication that reduces seizure threshold (e.g., clomipramine)
- •Cranial pathologies (e.g., holes, plates)
- •History of seizure or black-out concussion
- •Pregnancy
- •Previous treatment at Rogers Behavioral Health
研究组 & 干预措施
Active stimulation
Experimental
干预措施: transcranial direct current stimulation (Device)
Sham stimulation
Sham Comparator
干预措施: Sham transcranial direct current stimulation (Device)
结局指标
主要结局
Change in Quick Inventory of Depressive Symptomology from admission to discharge
时间窗: Up to 12 weeks
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
时间窗: Up to 12 weeks
次要结局
- Change in Obsessive-Compulsive Inventory-Revised from admission to discharge(Up to 12 weeks)
- Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge(Up to 12 weeks)
- Change in Subjective units of distress from admission to discharge(Up to 12 weeks)
- Number of treatment days between admission and discharge(Up to 12 weeks)
- Change in Intolerance of uncertainty scale from admission to discharge(Up to 12 weeks)
研究者
研究点 (1)
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