Paired tVNS With ERP in OCD
ConditionOCD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Florida
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults between the ages of 18 and 55
Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity
Participants must be willing and able to provide informed consent.
Disqualifiers
Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects.
People with an active eating disorder that requires treatment, but we will not exclude people who are in remission.
Current illicit or prescription drug abuse
Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded
Trial design
Design model
Parallel
Treatments tested in this trial
Sham
DeviceMRI (Magnetic Resonance Imaging) paired ERP/Sham YBOCs(Yale-Brown Obsessive Compulsive Scale) (4,8,12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.
tVNS
DeviceMRI (Magnetic Resonance Imaging) paired ERP/tVNS YBOC's (Yale-Brown Obsessive Compulsive Scale) (4, 8, 12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Active tVNS paired with 12 sessions of ERPActive comparator 1 intervention
Group B: Sham tVNS paired with 12 sessions of ERPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
A test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms. The scale can also provide a subscale score for obsessions and compulsions (range 0-20) separately.
Time frame
Baseline up to 1 month post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
International OCD Foundation
Collaborator
Source ClinicalTrials.gov