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Behavioural Intervention
Paired tVNS + ERP for OCD
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
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
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline 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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with OCD by a doctor and have a YBOCS score of 15 or higher, which means your OCD is at least moderately severe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 month post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month post treatment
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
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,310 Previous Clinical Trials
706,281 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be between 18 and 50 years old to participate.You are currently using illegal drugs or misusing prescription medications.You can still participate in the study if you are taking medication for your OCD or other mental health conditions.It's okay if you have received ERP treatment in the past, as long as it has been at least 12 months since your last treatment.You have been diagnosed with OCD by a doctor and have a YBOCS score of 15 or higher, which means your OCD is at least moderately severe.You have been diagnosed with OCD by a healthcare professional and have moderate to severe symptoms, as measured by a specific score (YBOCS) on a test.You have significant neurological conditions, autism spectrum disorder, severe mental illness, major sensory impairments that cannot be corrected, or serious medical conditions that could affect your brain function.You have an eating disorder that is currently being treated, but if you are in remission (not currently experiencing symptoms), you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tVNS paired with 12 sessions of ERP
- Group 2: Active tVNS paired with 12 sessions of ERP
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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