120 Participants Needed

Exposure and Response Prevention for Obsessive-Compulsive Disorder

MH
BM
HM
Overseen ByHannah McManus
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.36789

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.347810

Research Team

EB

Edna B Foa, PhD

Principal Investigator

University of Pennsylvania

HB

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
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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.
See 4 more

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)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental 2Experimental Treatment1 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 1Experimental Treatment1 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 ComparatorActive Control1 Intervention
Male participants will receive a brief EX/RP protocol within a 10-day window.

Find a Clinic Near You

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+

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

References

Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. [2020]
[Obsessive-compulsive disorders--inpatient behavior therapy]. [2006]
Controlled trial of exposure and response prevention in obsessive-compulsive disorder. [2019]
How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. [2018]
Treatment compliance and outcome in obsessive-compulsive disorder. [2019]
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. [2022]
Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]
Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. [2021]
Effectiveness of exposure and ritual prevention for obsessive-compulsive disorder: randomized compared with nonrandomized samples. [2009]
The effectiveness of exposure and response prevention combined with pharmacotherapy for obsessive-compulsive disorder: A systematic review and meta-analysis. [2022]