Clinical trial NCT04527302: Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)
Official title: A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: transcranial direct current stimulation
cognitive-behavioral therapy
Exposure and Response /Ritual Prevention
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The primary outcome was represented by the percent reduction of Y-BOCS scores
timeFrame: baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)
Secondary outcomes:
measure: Change in Obsessive Compulsive Inventory-Revised(OCI-R)
timeFrame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
measure: Change in Beck Depression Inventory(BDI)
timeFrame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
measure: Change in Perceived Stress Scale(PSS)
timeFrame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
measure: Change in Pittsburgh sleep quality index(PSQI)
timeFrame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
measure: Change in Side-effect questionnaire
timeFrame: 2 weeks，4 weeks to 8 weeks(after Session 2, 5, 10)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: