Exposure and Response Prevention for Obsessive-Compulsive Disorder

Overseen By Amy Rapp, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Psychotropic medication

Disqualifiers: Psychiatric disorders, Medical condition, others

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

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how people with obsessive-compulsive disorder (OCD) learn differently compared to those without the condition. It uses a treatment called Exposure and Response Prevention (Ex/RP), which involves gradually facing fears without performing compulsive behaviors. Participants with OCD will undergo 16 treatment sessions over eight weeks, while healthy participants will not receive treatment. Those with moderate OCD symptoms who haven't recently undergone similar therapy might be a good fit. The researchers aim to better understand the brain's role in OCD by analyzing behavior and brain activity. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for OCD.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current psychotropic medications to participate in this trial.

What prior data suggests that Exposure and Response Prevention is safe for individuals with OCD?

Research shows that Exposure and Response Prevention (Ex/RP) therapy is both safe and effective for treating obsessive-compulsive disorder (OCD). For many years, studies have found that about 80% of people with OCD experience significant relief from their symptoms with this therapy. Research confirms that Ex/RP leads to major and lasting improvements in OCD symptoms. Reports indicate no serious side effects, making it a safe choice for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Exposure and Response Prevention (Ex/RP) for treating Obsessive-Compulsive Disorder (OCD) because it takes a unique approach compared to typical medication treatments like SSRIs. Ex/RP is a behavioral therapy that directly targets the obsessive thoughts and compulsive behaviors at the heart of OCD by exposing patients to their fears in a controlled setting and preventing their usual compulsive responses. This method helps patients gradually build resilience and reduce their anxiety over time, potentially offering long-lasting relief without the side effects associated with medication. Additionally, Ex/RP can empower patients with practical skills to manage their symptoms independently.

What evidence suggests that Exposure and Response Prevention is effective for OCD?

Research has shown that Exposure and Response Prevention (Ex/RP) effectively reduces symptoms of obsessive-compulsive disorder (OCD). Studies have found that Ex/RP often outperforms other treatments in lowering OCD symptoms. In this trial, participants diagnosed with OCD will undergo Ex/RP therapy, which involves confronting their fears without engaging in their usual compulsive actions, gradually reducing anxiety. People with OCD typically experience significant improvement in their symptoms and related issues like depression when using Ex/RP. Overall, evidence strongly supports Ex/RP as a recommended method for treating OCD. ^{1 3 6 7 8}

Who Is on the Research Team?

Amy Rapp, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-50 with a primary diagnosis of OCD of at least moderate severity. It's not suitable for those with significant medical conditions, substance use disorders in the past year, recent Ex/RP therapy for OCD, current psychotropic medication use, or other psychiatric disorders.

Inclusion Criteria

English-speaking

You have the capacity to give informed consent.

You have been diagnosed with OCD that is at least moderately severe.

Exclusion Criteria

You have struggled with alcohol or drug addiction in the past year.

You have received treatment for OCD within the past six weeks that involved avoiding situations that trigger your symptoms and learning how to cope with your compulsions.

You are currently taking medication for mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants diagnosed with OCD will receive 16 sessions of exposure and response prevention (Ex/RP) delivered twice weekly over the course of eight weeks

8 weeks

16 visits (in-person)

Data Collection

EEG data will be collected during one experimental reinforcement learning task

1 day

1 visit (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 (Ex/RP)

Trial Overview The study examines how individuals with OCD and healthy controls employ learning strategies differently. It involves one experimental task to collect behavioral data and EEG recordings from each group (30 participants each), using computational modeling to link neural measures to behavior.

How Is the Trial Designed?

Group I: Behavioral Treatment Experimental Treatment 1 Intervention

Participants diagnosed with OCD will receive 16 sessions (1 hour long) of exposure and response prevention (Ex/RP) delivered twice weekly over the course of eight weeks.

Group II: No intervention Active Control 1 Intervention

Healthy controls will not receive treatment over the course of eight weeks.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

International OCD Foundation

Collaborator

Trials

3

Recruited

160+

Published Research Related to This Trial

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]

In a study of 377 in-patients with OCD, more frequent therapist-guided exposure and response prevention (ERP) sessions were linked to greater symptom reduction, emphasizing the importance of therapist involvement in treatment.

The effectiveness of self-guided ERP was found to be mediated by increased self-efficacy, suggesting that building patients' confidence can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. Voderholzer, U., Hilbert, S., Fischer, A., et al.[2020]

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 study involving 30 adults with OCD found that a stepped care approach to exposure and response prevention (ERP) was equally effective as standard ERP, with 67% of stepped care participants achieving significant improvement compared to 50% in the standard group.

The stepped care model significantly reduced treatment costs for patients and payers without compromising treatment efficacy or patient satisfaction, suggesting it could be a more accessible option for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. Tolin, DF., Diefenbach, GJ., Gilliam, CM.[2021]

In a study of 28 OCD patients undergoing exposure and ritual prevention (EX/RP) therapy, understanding the treatment rationale and compliance with exposure tasks were linked to better post-treatment outcomes.

However, compliance with ritual prevention and self-monitoring did not significantly affect symptom severity, suggesting that focusing on exposure tasks may be more critical for treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment compliance and outcome in obsessive-compulsive disorder. Abramowitz, JS., Franklin, ME., Zoellner, LA., 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]

Exposure and ritual prevention (EX/RP) is an effective treatment for obsessive-compulsive disorder (OCD), showing significant reductions in symptoms among 110 clinical patients in a real-world outpatient setting.

The outcomes for these clinical patients were comparable to those from four randomized controlled trials, suggesting that EX/RP is beneficial for a broader range of patients, regardless of treatment history or severity of OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of exposure and ritual prevention for obsessive-compulsive disorder: randomized compared with nonrandomized samples. Franklin, ME., Abramowitz, JS., Kozak, MJ., et al.[2009]

In a study involving 18 patients with OCD, exposure and response prevention therapy led to a significant reduction in obsessive-compulsive symptoms over three weeks, while a general anxiety management intervention showed no improvement.

The results indicate that the effectiveness of exposure and response prevention is due to its specific techniques, rather than general therapeutic factors, highlighting that standard anxiety management is not effective for treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled trial of exposure and response prevention in obsessive-compulsive disorder. Lindsay, M., Crino, R., Andrews, G.[2019]

A systematic review of 21 studies involving 1113 patients found that combining exposure and response prevention (ERP) with medication significantly improves symptoms of obsessive-compulsive disorder (OCD) compared to medication alone.

The combination treatment also leads to better maintenance of symptom improvement during follow-up, while D-cycloserine (DCS) did not enhance the effectiveness of ERP or improve depression levels in OCD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exposure and response prevention combined with pharmacotherapy for obsessive-compulsive disorder: A systematic review and meta-analysis. Mao, L., Hu, M., Luo, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6343408/

Exposure and response prevention for obsessive-compulsive ... In this review, we will describe the theoretical underpinnings and elements of ERP, examine the evidence for its effectiveness, and discuss new directions for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364921000646

A systematic review and meta-analysis on the effectiveness ... Our review suggests that ERP was superior to the other groups, including both neutral and active treatments, in reducing OCD symptomatology.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36186855/

The effectiveness of exposure and response prevention ... Conclusion: Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834260

Exposure Therapy in Mixed Reality for Obsessive ... In this single-center randomized clinical trial including 36 patients, MERP did not significantly reduce OCD symptom severity compared with an active control ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.973838/full

The effectiveness of exposure and response prevention ... Conclusion: Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with medication, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364912000498

Common pitfalls in exposure and response prevention (EX ... Thus EX/RP can lead to large and sustained reductions in OCD symptoms. A meta-analysis of RCTs that examined CBT programs for anxiety disorders found that EX/RP ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6935308/

Exposure and Response Prevention in the Treatment of ... Numerous clinical trials support the efficacy of exposure and response prevention (ERP) for the treatment of obsessive-compulsive disorder (OCD).

8. treatmyocd.com treatmyocd.com/what-is-ocd/what-is-erp

Exposure and Response Prevention (ERP) Therapy Decades of research show ERP therapy is the most effective treatment for OCD, helping about 80% of people experience significant symptom relief.