Exposure and Response Prevention for Obsessive-Compulsive Disorder

Recruiting at 1 trial location

Overseen By Hannah McManus

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Psychotropic medications

Disqualifiers: Birth control, Pregnancy, Neurologic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how hormones might impact therapy for obsessive-compulsive disorder (OCD), focusing on exposure and response prevention (EX/RP) treatment. The researchers aim to determine if timing the therapy with different phases of the menstrual cycle can affect its effectiveness. Women with OCD who have regular menstrual cycles might be suitable candidates, particularly if they can manage without medication temporarily. The trial also includes men with OCD as a comparison group. Participants will undergo EX/RP therapy in short sessions over a set period. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance OCD treatment strategies.

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 prior data suggests that Exposure & Response Prevention (EX/RP) is safe for treating OCD?

Research shows that Exposure and Response Prevention (EX/RP) is a safe and effective treatment for obsessive-compulsive disorder (OCD). Studies consistently demonstrate that it significantly reduces OCD symptoms. EX/RP involves gradually facing fears instead of avoiding them, which helps reduce anxiety over time.

EX/RP is generally well-tolerated, with no major reports of harmful effects. Therapists closely monitor the process, which involves gradual exposure to anxiety triggers, to ensure it remains manageable for participants.

Overall, EX/RP has a strong track record of safety and effectiveness, making it a reliable option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how timing can optimize the effectiveness of Exposure and Response Prevention (EX/RP) for Obsessive-Compulsive Disorder (OCD). EX/RP is already a well-established therapy for OCD, but this trial is investigating whether the treatment's timing within a menstrual cycle can enhance outcomes for women. By tailoring EX/RP sessions to specific phases of the menstrual cycle, researchers hope to uncover new insights into how hormonal fluctuations might impact therapeutic success. This approach could lead to more personalized and potentially more effective treatment plans for women with OCD.

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

Research has shown that Exposure and Response Prevention (EX/RP) effectively treats Obsessive-Compulsive Disorder (OCD). Studies indicate that EX/RP reduces OCD symptoms more effectively than other treatments, including both inactive and active therapies. In this trial, male participants will receive a brief EX/RP protocol within a 10-day window. Female participants will be randomized to receive the EX/RP protocol either within the first 10 days after the start of menstruation (early follicular phase) or during days 12-22 of the menstrual cycle (late follicular, early luteal phase). Specifically, patients in previous studies often demonstrated significant improvement in OCD symptoms and related depression when EX/RP was combined with medication. This therapy works by gradually exposing patients to their fears and helping them resist the urge to perform compulsive actions. Overall, EX/RP is a proven method for managing OCD symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Edna B Foa, PhD

Principal Investigator

University of Pennsylvania

Helen B Simpson, MD, PhD

Principal Investigator

New York State Psychiatric Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exposure & Response Prevention (EX/RP)

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.

How Is the Trial Designed?

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+

Research Foundation for Mental Hygiene, Inc. / Columbia University

Collaborator

Trials

1

Recruited

120+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

New York University

Collaborator

Trials

249

Recruited

229,000+

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]

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]

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]

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 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]

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]

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 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 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]

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