Combining Cognitive Behavioral Therapy with Transcranial Direct Current Stimulation for OCD
A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
This study is testing whether combining a type of therapy for OCD with a brain stimulation technique can help people feel better than just therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04527302 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining Exposure-based Cognitive-Behavioral Therapy (CBT) with Transcranial Direct Current Stimulation (tDCS) in treating patients with obsessive-compulsive disorder (OCD). A total of 60 participants will be randomized into two groups, receiving either active tDCS or sham tDCS alongside their CBT sessions. The study will assess clinical outcomes using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at multiple points during the treatment. Additionally, MRI and EEG will be utilized to explore potential neural mechanisms underlying the treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 with a confirmed diagnosis of OCD and a Y-BOCS score of 16 or higher.
Not a fit: Patients with serious medical or neurological conditions, or those who have previously undergone certain treatments for OCD, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the treatment outcomes for patients suffering from OCD.
How similar studies have performed: While the combination of CBT and tDCS is a novel approach, similar studies have shown promising results in enhancing treatment efficacy for various mental health conditions.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Shanghai, Shanghai
- Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Zhen Wang, PhD,MD — Shanghai Mental Health Center
- Study coordinator: Zhen Wang, PhD,MD
- Email: wangzhen@smhc.org.cn
- Phone: +86 34773516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.