tVNS + ERP for Obsessive-Compulsive Disorder
Trial Summary
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. However, you must be on stable doses for at least 6 weeks before the study, and no medication changes are allowed during the study.
What data supports the idea that tVNS + ERP for Obsessive-Compulsive Disorder is an effective treatment?
The available research shows that Exposure and Response Prevention (ERP) is a well-supported treatment for Obsessive-Compulsive Disorder (OCD). While the studies provided do not specifically mention tVNS combined with ERP, they highlight the effectiveness of ERP, often used with cognitive therapy, in reducing OCD symptoms. This suggests that combining ERP with other treatments like tVNS could potentially enhance its effectiveness, although direct evidence for this specific combination is not provided in the available research.12345
What safety data exists for tVNS + ERP treatment for OCD?
The provided research primarily focuses on the safety and efficacy of Exposure and Response Prevention (ERP) for OCD. ERP is recognized as a first-line, evidence-based treatment for OCD, with numerous clinical trials supporting its efficacy. However, concerns about safety, particularly for harm-related OCD symptoms, are noted, with some therapists reporting serious negative consequences. The research does not specifically address the safety of transcutaneous auricular vagus nerve stimulation (tVNS) combined with ERP, indicating a gap in the available safety data for this combined treatment approach.26789
Is Exposure and Response Prevention Therapy (ERP) a promising treatment for Obsessive-Compulsive Disorder?
Yes, Exposure and Response Prevention Therapy (ERP) is a promising treatment for Obsessive-Compulsive Disorder. It is considered one of the most effective psychological treatments for reducing OCD symptoms. ERP helps patients by exposing them to their fears and preventing them from performing compulsive behaviors, which can lead to significant relief from symptoms.1231011
What is the purpose of this trial?
In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.
Research Team
John Williamson, PhD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for adults aged 18-50 with moderate to severe Obsessive-Compulsive Disorder (OCD), as indicated by a YBOCS score of 15 or higher. Participants must be able to consent and have been on stable medication doses for at least six weeks. Those with drug abuse issues, major neurological conditions, active eating disorders, or recent ERP therapy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive active or sham tVNS paired with 12 sessions of ERP
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Exposure and Response Prevention Therapy (ERP)
- Sham
- tVNS
Exposure and Response Prevention Therapy (ERP) is already approved in United States, European Union, Canada for the following indications:
- Obsessive-Compulsive Disorder (OCD)
- Obsessive-Compulsive Disorder (OCD)
- Obsessive-Compulsive Disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
International OCD Foundation
Collaborator