56 Participants Needed

tVNS + ERP for Obsessive-Compulsive Disorder

RN
JW
JD
Overseen ByJennifer DeHart
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. However, you must be on stable doses for at least 6 weeks before the study, and no medication changes are allowed during the study.

What data supports the idea that tVNS + ERP for Obsessive-Compulsive Disorder is an effective treatment?

The available research shows that Exposure and Response Prevention (ERP) is a well-supported treatment for Obsessive-Compulsive Disorder (OCD). While the studies provided do not specifically mention tVNS combined with ERP, they highlight the effectiveness of ERP, often used with cognitive therapy, in reducing OCD symptoms. This suggests that combining ERP with other treatments like tVNS could potentially enhance its effectiveness, although direct evidence for this specific combination is not provided in the available research.12345

What safety data exists for tVNS + ERP treatment for OCD?

The provided research primarily focuses on the safety and efficacy of Exposure and Response Prevention (ERP) for OCD. ERP is recognized as a first-line, evidence-based treatment for OCD, with numerous clinical trials supporting its efficacy. However, concerns about safety, particularly for harm-related OCD symptoms, are noted, with some therapists reporting serious negative consequences. The research does not specifically address the safety of transcutaneous auricular vagus nerve stimulation (tVNS) combined with ERP, indicating a gap in the available safety data for this combined treatment approach.26789

Is Exposure and Response Prevention Therapy (ERP) a promising treatment for Obsessive-Compulsive Disorder?

Yes, Exposure and Response Prevention Therapy (ERP) is a promising treatment for Obsessive-Compulsive Disorder. It is considered one of the most effective psychological treatments for reducing OCD symptoms. ERP helps patients by exposing them to their fears and preventing them from performing compulsive behaviors, which can lead to significant relief from symptoms.1231011

What is the purpose of this trial?

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.

Research Team

JW

John Williamson, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

Participants must be willing and able to provide informed consent
Meet DSM-5 criteria for OCD, based on a structured clinical interview and have a YBOCS score of 15 or higher indicating at least moderate OCD severity

Exclusion Criteria

I am taking medication for OCD or another mental health condition.
My medications have been the same for at least 6 weeks.
Current illicit or prescription drug abuse
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham tVNS paired with 12 sessions of ERP

12 weeks
12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Exposure and Response Prevention Therapy (ERP)
  • Sham
  • tVNS
Trial Overview 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.
Participant Groups
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

Exposure and Response Prevention Therapy (ERP) is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Exposure and Response Prevention Therapy for:
  • Obsessive-Compulsive Disorder (OCD)
πŸ‡ͺπŸ‡Ί
Approved in European Union as Exposure and Response Prevention Therapy for:
  • Obsessive-Compulsive Disorder (OCD)
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Approved in Canada as Exposure and Response Prevention Therapy for:
  • Obsessive-Compulsive Disorder (OCD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

International OCD Foundation

Collaborator

Trials
3
Recruited
160+

Findings from Research

A study involving 127 participants with OCD found that integrating cognitive therapy with exposure and response prevention (ERP) significantly improved treatment outcomes compared to ERP alone, leading to greater reductions in symptoms and obsessive beliefs.
More patients in the ERP + cognitive therapy group were classified as treatment responders, indicating that combining these approaches can enhance the effectiveness of OCD treatment.
Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting.Rector, NA., Richter, MA., Katz, D., et al.[2022]
Exposure and response prevention (ERP) therapy shows a small-to-medium effect size in reducing symptoms for patients with obsessive-compulsive disorder (OCD) and Tourette syndrome (TS), based on a meta-analysis of 18 studies involving 1057 OCD patients and 267 TS patients.
The study suggests that while ERP is effective, combining it with other therapies and developing online ERP services could enhance treatment outcomes, as the exact neurological mechanisms behind its efficacy remain unclear.
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis.Yan, J., Cui, L., Wang, M., et al.[2022]
A meta-analysis of 13 trials showed that group cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for obsessive-compulsive disorder (OCD), with a strong pre-post effect size of 1.18.
Group CBT/ERP outperformed waiting list controls and achieved better results than pharmacological treatments in some studies, indicating its efficacy as a psychological intervention for OCD.
Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis.JΓ³nsson, H., Hougaard, E.[2018]

References

Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting. [2022]
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. [2022]
Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]
Cognitive behavioural therapy with exposure and response prevention in the treatment of obsessive-compulsive disorder: A systematic review and meta-analysis of randomised controlled trials. [2021]
Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. [2019]
Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]
How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. [2018]
Exposure and Response Prevention for Obsessive-Compulsive Disorder: A Case Study of a Veteran With Violent Intrusive Thoughts. [2020]
Exposure and Response Prevention in the Treatment of Obsessive-Compulsive Disorder: Current Perspectives. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
An Avoidance-Based Rodent Model of Exposure With Response Prevention Therapy for Obsessive-Compulsive Disorder. [2022]
Metacognitive therapy versus exposure and response prevention for pediatric obsessive-compulsive disorder. A case series with randomized allocation. [2018]
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