Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Combination Product: ERP combined with high-definition active tDCSCombination Product: ERP combined with sham tDCS
- Registration Number
- NCT04527302
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
(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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active tDCS+exposure based CBT ERP combined with high-definition active tDCS The exposure and response prevention (ERP) treatment concurrently with an anode transcranial direct current stimulation over the mPFC will be applied 8 times (tDCS+ERP, 8sessions) in the whole treatment. sham tDCS +exposure based CBT ERP combined with sham tDCS the exposure and response prevention (ERP) treatment concurrently with an sham transcranial direct current stimulation over the mPFC will be applied 8 times (sham tDCS+ERP, 8 sessions) in the whole treatment.
- Primary Outcome Measures
Name Time Method The primary outcome was represented by the percent reduction of Y-BOCS scores 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%.
- Secondary Outcome Measures
Name Time Method Change in Beck Depression Inventory(BDI) baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10) It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Change in Obsessive Compulsive Inventory-Revised(OCI-R) baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10) It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.
Change in Pittsburgh sleep quality index(PSQI) baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10) The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Change in Side-effect questionnaire 2 weeks，4 weeks to 8 weeks(after Session 2, 5, 10) It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Change in Perceived Stress Scale(PSS) baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10) It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.
Change in Beck Anxiety Inventory (BAI) baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10) It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China