Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2022-06-27
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active tVNS paired with 12 sessions of ERP
tVNS
MRI (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.
Sham tVNS paired with 12 sessions of ERP
Sham
MRI (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.
Interventions
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Sham
MRI (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
MRI (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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable
18 Years
55 Years
ALL
No
Sponsors
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International OCD Foundation
UNKNOWN
University of Florida
OTHER
Responsible Party
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Principal Investigators
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John Williamson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OCR41263
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202101733
Identifier Type: -
Identifier Source: org_study_id
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