Anxiety & Depression Association of America

Paired tVNS With ERP in OCD

Purpose

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.

Condition

Eligibility

Eligible Ages: Between 18 Years and 55 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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.

Exclusion Criteria

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 - 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Active tVNS paired with 12 sessions of ERP		Device: 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 Comparator Sham tVNS paired with 12 sessions of ERP		Device: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Florida

Study Contact

Jennifer DeHart
352-316-7154
jdehart@ufl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.