tVNS + ERP for Obsessive-Compulsive Disorder

Overseen By Laura Jones, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Neurological conditions, Autism, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve therapy for individuals with Obsessive-Compulsive Disorder (OCD). It combines a technique called tVNS, which uses a device to stimulate a nerve in the ear to calm the brain, with standard Exposure and Response Prevention Therapy (ERP) to determine if it enhances treatment response. Participants will receive either active nerve stimulation or a sham (inactive) version during therapy. The trial seeks adults with moderate OCD symptoms who are willing to maintain their current medications and have tried ERP at least a year ago. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance OCD treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcutaneous vagal nerve stimulation (tVNS) is generally safe, with most people experiencing only mild and short-term side effects. Although specific information on using tVNS for obsessive-compulsive disorder (OCD) is limited, studies on other conditions suggest it is well-tolerated. For example, in individuals with rheumatoid arthritis, tVNS proved safe and helped reduce symptoms. This offers some reassurance about its safety for those considering participation in a clinical trial involving tVNS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tVNS (transcutaneous vagus nerve stimulation) paired with Exposure and Response Prevention Therapy (ERP) for Obsessive-Compulsive Disorder (OCD) because it introduces a novel approach to treatment. Unlike traditional medications for OCD, which often target serotonin pathways, tVNS involves stimulating the vagus nerve through the skin, potentially offering a non-invasive alternative with fewer side effects. Additionally, this method is combined with ERP, a well-established behavioral therapy, to enhance its effectiveness. The use of a sham tVNS group allows researchers to rigorously assess the true impact of tVNS, paving the way for innovative treatment strategies in mental health.

What evidence suggests that this trial's treatments could be effective for OCD?

Research has shown that transcutaneous vagal nerve stimulation (tVNS) might alleviate OCD symptoms. One study found that tVNS improved sleep and reduced anxiety in people with OCD. In another study, three out of seven OCD patients who received this treatment noticed an improvement in their symptoms. Although the exact mechanism remains unclear, tVNS appears to aid in managing emotions and stress. In this trial, participants will receive either active tVNS or sham tVNS, both paired with exposure and response prevention therapy, a common OCD treatment. This combination could potentially enhance the therapy's effectiveness. ^{2 4 6 7 8}

Who Is on the Research Team?

John Williamson, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Active tVNS paired with 12 sessions of ERP Active Control 1 Intervention

Group II: Sham tVNS paired with 12 sessions of ERP Placebo Group 1 Intervention

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

Approved in United States as Exposure and Response Prevention Therapy for:

• Obsessive-Compulsive Disorder (OCD)

Approved in European Union as Exposure and Response Prevention Therapy for:

• Obsessive-Compulsive Disorder (OCD)

Approved in Canada as Exposure and Response Prevention Therapy for:

• Obsessive-Compulsive Disorder (OCD)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A case study of a veteran with obsessive-compulsive disorder (OCD) showed significant improvement after 34 sessions of Exposure and Response Prevention (ERP) therapy over 14 months, including 15 sessions via video telehealth.

The patient experienced a notable reduction in OCD symptoms and related depression and anxiety, as evidenced by decreased scores on standardized assessment tools, indicating that ERP can be effectively adapted for veterans with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure and Response Prevention for Obsessive-Compulsive Disorder: A Case Study of a Veteran With Violent Intrusive Thoughts. Siffert, V., Riahi, C., Stanley, MA., et al.[2020]

In a study involving 61 participants, both exposure and response prevention (ERP) and cognitive therapy (CT) were found to be equally effective in treating obsessive-compulsive disorder, with no significant differences in how they affected obsessions and compulsions over time.

The research indicated that changes in compulsive behaviors were more predictive of overall treatment success than changes in obsessive thoughts, suggesting that both therapies primarily facilitate change through the reduction of compulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. Anholt, GE., Kempe, P., de Haan, E., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. Jónsson, H., Hougaard, E.[2018]

Serious negative consequences (SNC) from exposure and response prevention (ERP) therapy for obsessive-compulsive disorder (OCD) are extremely rare, occurring in only 0.05% of adult clients and 0.01% of youth clients, indicating that ERP is a safe treatment option.

Despite some therapists' concerns, the study found that most therapists are willing to treat harm-related OCD, and improving communication about the safety and rationale of ERP could enhance access to this effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. Schneider, SC., Knott, L., Cepeda, SL., et al.[2020]

Exposure and response prevention (ERP) is recognized as a first-line, evidence-based treatment for obsessive-compulsive disorder (OCD), supported by numerous clinical trials demonstrating its efficacy in both children and adults.

The review highlights the importance of understanding the behavioral and neurobiological mechanisms behind ERP, as well as discussing predictors of treatment outcomes and strategies to enhance the implementation and dissemination of this effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure and Response Prevention in the Treatment of Obsessive-Compulsive Disorder: Current Perspectives. Law, C., Boisseau, CL.[2023]

Metacognitive therapy (MCT) for children with obsessive-compulsive disorder (OCD) showed clinically and statistically significant improvements in symptom severity after treatment, based on a study involving 10 participants.

The benefits of MCT were maintained at both the 3-month and 2-year follow-ups, suggesting it could be a promising alternative to the traditional exposure with ritual prevention (ERP) therapy for pediatric OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus exposure and response prevention for pediatric obsessive-compulsive disorder. A case series with randomized allocation. Simons, M., Schneider, S., Herpertz-Dahlmann, B.[2018]

In a study of 288 adults with OCD undergoing residential exposure and response prevention (ERP), those who showed greater willingness to experience unpleasant thoughts and feelings reported faster reductions in OCD symptoms during treatment.

This willingness was found to be a significant factor in treatment success, suggesting that embracing discomfort may enhance the effectiveness of ERP for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. Reid, AM., Garner, LE., Van Kirk, N., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 new rodent model of exposure with response prevention (Ext-RP) demonstrated that most rats reduced their avoidance behaviors after treatment, indicating the potential effectiveness of this approach in understanding obsessive-compulsive disorder (OCD).

Pharmacologic inactivation of the lateral orbitofrontal cortex (lOFC) and deep brain stimulation (DBS) of the ventral striatum both successfully eliminated persistent avoidance behaviors, suggesting that hyperactivity in the lOFC may hinder the effectiveness of ERP therapy in OCD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Avoidance-Based Rodent Model of Exposure With Response Prevention Therapy for Obsessive-Compulsive Disorder. Rodriguez-Romaguera, J., Greenberg, BD., Rasmussen, SA., et al.[2022]

Cognitive Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) shows a large effect size (g = 0.74) in reducing OCD symptoms across 36 studies involving 2020 patients, but this effect diminishes with increasing age.

While CBT with ERP is more effective than psychological placebo and pharmacological treatments, its efficacy is influenced by the type of control used in studies and is significantly linked to researcher allegiance, raising concerns about the methodological rigor of the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Reid, JE., Laws, KR., Drummond, L., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9596914/

Therapeutic applications of transcutaneous auricular vagus ... To date, taVNS has been used to help alleviate symptoms not only of epilepsy but also splanchnic diseases (e.g., heart failure) (8), stroke (9, 10) and tinnitus ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X0800003X

A pilot study of vagus nerve stimulation (VNS) for treatment ... Of the seven patients with OCD who received stimulation, three were acute responders, based on the Y-BOCS, and there was some improvement in Y-BOCS scores over ...

3. researchgate.net researchgate.net/publication/377581783_Effectiveness_of_Vagal_Nerve_Stimulation_on_Obsessive_Compulsive_Disorder_Among_Post_Covid-19_Infected_Individuals

Effectiveness of Vagal Nerve Stimulation on Obsessive ... Result: With a p value of 0.001, transcutaneous auricular vagal nerve activation significantly improved sleepquality and reduced anxiety after 4 weeks.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875019/

Effects of transcutaneous auricular vagus nerve stimulation ... While the mechanisms of taVNS remain unclear, studies have discovered its effects in modulating socially relevant emotional and visceral states.

5. withpower.com withpower.com/trial/phase-obsessive-compulsive-disorder-ocd-5-2022-0a896

tVNS + ERP for Obsessive-Compulsive Disorder The study tests if tVNS (non-invasive nerve stimulation) can boost the effectiveness of exposure and response prevention therapy in OCD treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...

7. aetna.com aetna.com/cpb/medical/data/100_199/0191.html

Vagus Nerve Stimulation - Medical Clinical Policy Bulletins VNS with a miniaturized neurostimulator was safe and well-tolerated and reduced signs and symptoms of RA in patients with multidrug-refractory disease.

8. ambetterhealth.com ambetterhealth.com/content/dam/centene/Coordinated%20Care/ambetter/policies/clinicalpolicies/WA.CP.MP.12.pdf?ref=massmarketretailers.com

Clinical Policy: Vagal Nerve Stimulation Noninvasive auricular tVNS stimulates the afferent auricular branch of the vagus nerve located medial of the tragus at the entry of the acoustic meatus. Given ...