A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome was represented by the percent reduction of Y-BOCS scores
研究概览
简要总结
This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Direct Current Stimulation (tDCS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).
详细描述
The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT（ERP）combined with tDCS over the prefrontal cortex (mPFC) in treatment of OCD patients. 60 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into two groups (i.e. ERP+active tDCS or ERP+sham tDCS stimulation). Over a two-month period, all patients are received 10 sessions of individual CBT, including 8 sessions of concurrent tDCS with ERP (tDCS+ERP). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive MRI scan and EEG.
The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) 18-50 years old, with at least 9 years of education, (2) Y-BOCS score ≥16, (3) no history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary), (4) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study (5) no previous exposure to ERP or tDCS.
排除标准
- •history of serious medical, neurological illness or other psychotic disorders other than OCD
- •The inability to receive tDCS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery.
- •Participants who have received ECT, rTMS, tDCS and CBT in the past.
- •Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
- •serious suicide risk
结局指标
主要结局
The primary outcome was represented by the percent reduction of Y-BOCS scores
时间窗: baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)
We defined the tDCS+ERP treatment response as the percent reduction of Y-BOCS scores greater than or equal to 35%.
次要结局
- Change in Beck Depression Inventory(BDI)(baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10))
- Change in Obsessive Compulsive Inventory-Revised(OCI-R)(baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10))
- Change in Pittsburgh sleep quality index(PSQI)(baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10))
- Change in Side-effect questionnaire(2 weeks，4 weeks to 8 weeks(after Session 2, 5, 10))
- Change in Perceived Stress Scale(PSS)(baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10))
- Change in Beck Anxiety Inventory (BAI)(baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10))
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center