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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
Adults between the ages of 18 and 55
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 month post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,300 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
303 Patients Enrolled for Obsessive-Compulsive Disorder
International OCD FoundationUNKNOWN
2 Previous Clinical Trials
118 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
118 Patients Enrolled for Obsessive-Compulsive Disorder
John Williamson, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Exposure and Response Prevention Therapy (ERP) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05580614 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Sham tVNS paired with 12 sessions of ERP, Active tVNS paired with 12 sessions of ERP
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure and Response Prevention Therapy (ERP) Highlights & Side Effects. Trial Name: NCT05580614 — N/A
Exposure and Response Prevention Therapy (ERP) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580614 — N/A
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05580614 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 40 or older eligible to join this research?

"This medical trial is searching for participants aged 18 to 50."

Answered by AI

What demographics qualify to participate in this experiment?

"This medical trial is actively seeking 56 adults between the ages of 18 and 50, who have been diagnosed with OCD using DSM-5 criteria through a structured clinical interview. Additionally, all candidates must be willing to provide informed consent and have a Yale–Brown Obsessive Compulsive Scale (YBOCS) score greater than 15 - indicating moderate severity or higher."

Answered by AI

What is the cap on the number of individuals taking part in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that this medical trial, initially posted in June 27th 2022, is actively enrolling participants. 56 patients are needed at one location to complete the research study."

Answered by AI

Is this research study still welcoming participants?

"Clinicaltrials.gov laid out that this medical study is recruiting participants, which was initially posted on June 27th 2022 and has been modified as recently as October 13th 2022."

Answered by AI

Who else is applying?

What state do they live in?
North Dakota
Texas
Oklahoma
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
University of Florida

Why did patients apply to this trial?

I wanna get cured. Lonely with this disease because I can’t talk about it.
PatientReceived no prior treatments
~11 spots leftby Aug 2024