tVNS + ERP for Obsessive-Compulsive Disorder

Overseen By Jennifer DeHart

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

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{1 2 3 10 11}

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

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

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

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+

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.

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. [2019]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Exposure and Response Prevention for Obsessive-Compulsive Disorder: A Case Study of a Veteran With Violent Intrusive Thoughts. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Exposure and Response Prevention in the Treatment of Obsessive-Compulsive Disorder: Current Perspectives. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

An Avoidance-Based Rodent Model of Exposure With Response Prevention Therapy for Obsessive-Compulsive Disorder. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus exposure and response prevention for pediatric obsessive-compulsive disorder. A case series with randomized allocation. [2018]