Clinical trial NCT06717165: Efficacy and Mechanism of Augmentation of Cognitive Behavioral Therapy With Transcranial Alternating Current Stimulation(tACS) for Obsessive-Compulsive Disorder (OCD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Keywords: cognitive-behavioral therapy
exposure and response prevention
transcranial alternating current stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
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 Alternating Current Stimulation (tACS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by electroencephalography (EEG).

Detailed description: The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT (ERP) combined with tACS over the prefrontal cortex (mPFC) in treatment of OCD patients. 120 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into three groups (ERP+active tACS, ERP+sham tACS stimulation and waiting list). All patients except those in the waiting list will be received 10 sessions of individual CBT in a two-month period, including 8 sessions of concurrent tACS with ERP (tACS+ERP). Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). 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 EEG at each point. The current study aims to explore whether the administration of online tACS together with ERP (tACS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Eligibility 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 2 months before entering the study and continued the same medication throughout the study
* No previous exposure to ERP or tACS

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

Primary outcomes:
measure: To explore the differences in treatment efficacy between active and sham transcranial alternating current stimulation (tACS) concurrent with exposure and response prevention (ERP)(tACS+ERP) in patients with obsessive-compulsive disorder (OCD).
timeFrame: baseline, 2weeks, 4weeks,8 weeks (baseline, after Session 2, 5, 10)
Secondary outcomes:
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: