Combining Cognitive Behavioral Therapy with Brain Stimulation for OCD Treatment
A Randomized, Double-Blind, Clinical Trial to Study the Efficacy and Mechanisms of Transcranial Alternating Current Stimulation (tACS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
This study is testing if combining a type of therapy called Cognitive Behavioral Therapy with a brain stimulation technique can help people with obsessive-compulsive disorder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06717165 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining exposure-based Cognitive Behavioral Therapy (CBT) with Transcranial Alternating Current Stimulation (tACS) in treating patients with obsessive-compulsive disorder (OCD). A total of 120 participants will be randomized into three groups: one receiving active tACS with CBT, another receiving sham tACS with CBT, and a waiting list group. The treatment will consist of 10 sessions over two months, with assessments of OCD symptoms and EEG monitoring to explore the neural mechanisms involved. The goal is to determine if the combination of tACS and CBT enhances treatment outcomes for OCD patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a confirmed diagnosis of OCD and a Y-BOCS score of 16 or higher.
Not a fit: Patients with severe OCD symptoms that hinder assessment, those with serious medical or neurological conditions, or those currently on antiepileptic medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with OCD.
How similar studies have performed: While the combination of CBT and tACS is a novel approach, previous studies have shown promise in using tACS for various neurological and psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
The investigators recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied: Inclusion Criteria: * 18-60 years old * With at least 9 years of education * Y-BOCS score ≥16 * 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) * Medication-free or had received stable medication for at least 8 weeks before entering the study and continued the same medication throughout the study Exclusion Criteria: * History of serious medical, neurological illness or other psychotic disorders other than OCD * OCD symptoms are severe, preventing the patient from completing the required assessment and examination * Serious suicide risk * Women who are pregnant or planning to become pregnant * Currently taking antiepileptic medication * Clinically significant physical illnesses or laboratory test abnormalities that have clinical significance * Previous completion of a full course of CBT/ERP treatment
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, 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.