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

NCT ID: NCT04527302

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2024-08-30

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active tDCS+exposure based CBT

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.

Group Type: ACTIVE_COMPARATOR

ERP combined with high-definition active tDCS

Intervention Type: COMBINATION_PRODUCT

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).

sham tDCS +exposure based CBT

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.

Group Type: SHAM_COMPARATOR

ERP combined with sham tDCS

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Zhen Wang

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 34773516

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 64387250

Facility Contacts

Zhen Wang

Role: primary

Other Identifiers

SMHC-OCD-008

Identifier Type: -

Identifier Source: org_study_id