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RECRUITINGINTERVENTIONAL

Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)

A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

We recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied: Who May Qualify: (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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
We recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied: Inclusion Criteria: (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. Exclusion Criteria: * 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

Treatments Being Tested

COMBINATION_PRODUCT

ERP combined with high-definition active tDCS

The active tDCS +ERP referred to a period of tDCS applied in the first 20 minutes of the ERP treatment (the tDCS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tDCS+ERP treatment. The tDCS device will deliver a direct current of 1.5mA during 20 minutes. Anode electrode will be localized in front of the mPFC on the FpZ point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AF7, AF8, F3, F4).

COMBINATION_PRODUCT

ERP combined with sham tDCS

Patients will get the same CBT setting as the active tDCS group and they were applied the sham tDCS cocurrently with ERP. The sham tDCS device is the same as the active comparator's except that the sham tDCS will only deliver a current stimulation for the first and last 15 seconds in order to produce somatic sensation in patients similar to that induced by the active tDCS.

Locations (1)

Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China