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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Obsessive-Compulsive Disorder

Treatments: Combination Product: ERP combined with sham tDCS; Combination Product: ERP combined with high-definition active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04527302

SMHC-OCD-008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

active tDCS+exposure based CBT

Active Comparator group

Description:

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.

Treatment:

Combination Product: ERP combined with high-definition active tDCS

sham tDCS +exposure based CBT

Sham Comparator group

Description:

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.

Treatment:

Combination Product: ERP combined with sham tDCS