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Behavioural Intervention
tVNS + ERP for Obsessive-Compulsive Disorder
N/A
Recruiting
Led By John Williamson, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month post treatment
Awards & highlights
Summary
This trial will research how combining tVNS and ERP can improve OCD treatment success. Therapists and patients will give feedback on how well it works.
Who is the study for?
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.
What is being tested?
The study tests if tVNS (non-invasive nerve stimulation) can boost the effectiveness of exposure and response prevention therapy in OCD treatment. It will measure tolerability, impact on OCD symptoms, and brain changes due to the combined treatment approach.
What are the potential side effects?
While specific side effects are not listed here, tVNS generally may cause discomfort at the stimulation site, headache, voice changes or hoarseness. Side effects from ERP could include temporary increases in anxiety and distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 month post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active tVNS paired with 12 sessions of ERPActive Control1 Intervention
Group II: Sham tVNS paired with 12 sessions of ERPPlacebo Group1 Intervention
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,339 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
303 Patients Enrolled for Obsessive-Compulsive Disorder
International OCD FoundationUNKNOWN
2 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
99 Patients Enrolled for Obsessive-Compulsive Disorder
John Williamson, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for OCD or another mental health condition.My medications have been the same for at least 6 weeks.I am between 18 and 55 years old.I had ERP treatment over a year ago.I do not have major neurological conditions or severe diseases affecting my brain.I am between 18 and 50 years old.You have been diagnosed with OCD by a healthcare professional and have moderate to severe symptoms, as measured by a specific score (YBOCS) on a test.
Research Study Groups:
This trial has the following groups:- Group 1: Active tVNS paired with 12 sessions of ERP
- Group 2: Sham tVNS paired with 12 sessions of ERP
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05580614 — N/A
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