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

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

Recruiting
18-50 years
All
Phase N/A

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Overview

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).

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.

Eligibility

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

Study details
    Obsessive-Compulsive Disorder

NCT04527302

Shanghai Mental Health Center

29 April 2024

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