RECRUITING

Paired tVNS With ERP in OCD

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD

Quick Facts

Study Start:2022-06-27

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05580614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jennifer DeHart

CONTACT

352-316-7154

jdehart@ufl.edu

Principal Investigator

John Williamson, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

John Williamson, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-27

Study Completion Date2025-09-30

Study Record Updates