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

NCT04527302 | Recruiting

• 1 other identifier: SMHC-OCD-008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Keywords

transcranial direct current stimulation; cognitive-behavioral therapy; Exposure and Response /Ritual Prevention

Outcome Measures

Primary Outcomes (1)

• The primary outcome was represented by the percent reduction of Y-BOCS scores

  We defined the tDCS+ERP treatment response as the percent reduction of Y-BOCS scores greater than or equal to 35%.

  baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)

Secondary Outcomes (6)

• Change in Obsessive Compulsive Inventory-Revised(OCI-R)

  baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)

• Change in Beck Depression Inventory(BDI)

  baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)

• Change in Beck Anxiety Inventory (BAI)

  baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)

• Change in Perceived Stress Scale(PSS)

  baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)

• Change in Pittsburgh sleep quality index(PSQI)

  baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)

Study Arms (2)

active tDCS+exposure based CBT

ACTIVE COMPARATOR

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.

Combination Product: ERP combined with high-definition active tDCS

sham tDCS +exposure based CBT

SHAM COMPARATOR

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.

Combination Product: ERP combined with sham tDCS

Interventions

ERP combined with high-definition active tDCS 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).

active tDCS+exposure based CBT

ERP combined with sham tDCS 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.

sham tDCS +exposure based CBT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Wang, PhD,MD

CONTACT

+86 34773516; wangzhen@smhc.org.cn

Zhen Wang, PhD,MD

CONTACT

+86 64387250; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start: October 26, 2020
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)