Exposure and Response Prevention for Obsessive-Compulsive Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Helen B Simpson, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Must not be taking: Psychotropic medications

Disqualifiers: Birth control, Pregnancy, Neurologic conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies how hormonal changes during the menstrual cycle affect the effectiveness of a common OCD therapy called Exposure and Response Prevention (EX/RP). Women will undergo therapy at various points in their cycle, and men will also participate for comparison. The goal is to see if timing therapy with hormonal changes can improve outcomes for women with OCD.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic medications, as the trial requires that participants have not used them in the past 12 weeks.

What data supports the effectiveness of the treatment Exposure & Response Prevention (EX/RP) for Obsessive-Compulsive Disorder?

Research shows that Exposure and Response Prevention (EX/RP) is considered the most effective treatment for Obsessive-Compulsive Disorder (OCD), with studies indicating that it helps reduce symptoms by encouraging patients to face their fears and resist the urge to perform compulsive behaviors. ^{1 2 3 4 5}

Is exposure and response prevention (ERP) safe for treating obsessive-compulsive disorder (OCD)?

Some therapists have concerns about the safety of ERP, especially for certain OCD symptoms, but there is no specific evidence of serious negative consequences from the studies provided. ^{3 6 7 8 9}

How is the treatment Exposure and Response Prevention (EX/RP) unique for obsessive-compulsive disorder?

Exposure and Response Prevention (EX/RP) is unique because it involves gradually exposing patients to their fears and preventing their usual compulsive responses, which helps them learn to manage anxiety without relying on compulsions. Unlike some other treatments, it focuses on behavior change rather than medication, and it can be combined with medication for enhanced effectiveness. ^{3 4 7 8 10}

Research Team

Edna B Foa, PhD

Principal Investigator

University of Pennsylvania

Helen B Simpson, MD, PhD

Principal Investigator

New York State Psychiatric Institute

Eligibility Criteria

This trial is for men and women aged 18-45 with moderate to severe OCD. Women must have regular menstrual cycles and not be on psychotropic meds for the past 12 weeks. Participants can't use certain birth controls, be pregnant, or have conditions that conflict with MRI scans or elevate risks.

Inclusion Criteria

You have OCD that is moderate or severe in intensity.

Women who do not have regular periods will be excluded.

Willingness and ability to give written informed consent after full explanation of study procedures

Exclusion Criteria

Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study

Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices)

You use birth control that affects your menstrual cycle or have reached menopause.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuroimaging and Hormonal Assays

Participants complete neuroimaging, hormonal assays, and symptom ratings before starting EX/RP

1 week

Treatment

Participants receive a brief EX/RP protocol. Female participants are randomized to receive treatment during specific menstrual cycle phases.

10 days

Follow-up

Participants are monitored for changes in brain activation and OCD symptoms using fMRI and symptom scales

4 weeks

Treatment Details

Interventions

• Exposure & Response Prevention (EX/RP) (Behavioral Intervention)

Trial Overview The study tests how hormones during different menstrual cycle phases affect brain response in women undergoing Exposure & Response Prevention (EX/RP) therapy for OCD. It aims to understand hormone influence on the fear extinction network and OCD symptoms.

Participant Groups

Group I: Experimental 2 Experimental Treatment 1 Intervention

Half of female participants will be randomized to receive a brief EX/RP protocol in days 12-22 of the menstrual cycle (late follicular, early luteal phase).

Group II: Experimental 1 Experimental Treatment 1 Intervention

Half of female participants will be randomized to receive a brief EX/RP protocol within the first 10 days after the start of menstruation (early follicular phase).

Group III: Active Comparator Active Control 1 Intervention

Male participants will receive a brief EX/RP protocol within a 10-day window.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Research Foundation for Mental Hygiene, Inc. / Columbia University

Collaborator

Trials

1

Recruited

120+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

Dr. Elizabeth B. Ford

New York State Psychiatric Institute

Chief Medical Officer since 2023

MD

Dr. Joshua A. Gordon

New York State Psychiatric Institute

Chief Executive Officer

MD, PhD in Neuroscience

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

Dr. Jeffrey Borenstein

Research Foundation for Mental Hygiene, Inc.

Chief Executive Officer since 2012

MD from New York University, undergraduate degree from Harvard University

Dr. John McDaniel

Research Foundation for Mental Hygiene, Inc.

Chief Medical Officer since 2018

MD from Harvard Medical School

New York University

Collaborator

Trials

249

Recruited

229,000+

Dr. Fritz François

New York University

Chief Medical Officer

MD from NYU Grossman School of Medicine

Dr. Robert I. Grossman

New York University

Chief Executive Officer since 2007

MD from NYU Grossman School of Medicine

Findings from Research

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 therapy with response prevention is considered the most effective treatment for obsessive-compulsive disorder (OCD), highlighting its importance in managing this condition.

This therapy has been successfully applied to both outpatient and inpatient settings, demonstrating its versatility and effectiveness across different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorders--inpatient behavior therapy]. Winkelmann, G., Hohagen, F.[2006]

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 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]

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]

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]

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]

References

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

Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorders--inpatient behavior therapy]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Controlled trial of exposure and response prevention in obsessive-compulsive disorder. [2019]

4. 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]

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

Treatment compliance and outcome in obsessive-compulsive disorder. [2019]

6. 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]

7. 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]

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

Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. [2021]

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

Effectiveness of exposure and ritual prevention for obsessive-compulsive disorder: randomized compared with nonrandomized samples. [2009]

10. Switzerland 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. [2022]