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Exposure and Response Prevention for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By Edna B Foa, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects aged between 18- 45
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to approximately 4 weeks later
Awards & highlights

Study Summary

This trial will study whether delivering exposure and response prevention therapy to women during different phases in their menstrual cycle affects the success of the therapy and the women's OCD symptoms.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a psychological therapy rather than medication, side effects may include increased anxiety or stress during exposure exercises, temporary worsening of OCD symptoms, and emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to approximately 4 weeks later
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately 4 weeks later for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OCD Symptoms
fMRI
Secondary outcome measures
rs fMRI

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exposure & Response Prevention (EX/RP)
2014
N/A
~80

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER
475 Previous Clinical Trials
153,787 Total Patients Enrolled
25 Trials studying Obsessive-Compulsive Disorder
947 Patients Enrolled for Obsessive-Compulsive Disorder
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,089 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,636 Total Patients Enrolled
66 Trials studying Obsessive-Compulsive Disorder
13,981 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Exposure & Response Prevention (EX/RP) Clinical Trial Eligibility Overview. Trial Name: NCT05359562 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Active Comparator, Experimental 1, Experimental 2
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure & Response Prevention (EX/RP) Highlights & Side Effects. Trial Name: NCT05359562 — N/A
Exposure & Response Prevention (EX/RP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359562 — N/A
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05359562 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this research study?

"Affirmative. Clinicaltrials.gov data attests to the active recruitment period of this study, which was initially published on June 15th 2022 and revised on July 7th 2022. This medical trial requires 120 participants from 2 sites for its completion."

Answered by AI

Who can partake in the experiment, and what criteria must they meet?

"This medical trial is recruiting 120 subjects, aged 18 to 45 years old and diagnosed with OCD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Women must be menstruating regularly, participants need not have taken psychotropic drugs in the past 12 weeks, exhibit moderate or greater severity symptoms at entry point and agree to a treatment free period. In addition willing participants must provide written informed consent after being briefed on study procedures."

Answered by AI

How many subjects are enrolled in this clinical experiment?

"Affirmative. The clinical trial is recruiting according to the data listed on clinicaltrials.gov, which was first posted on June 15th 2022 and has been modified most recently as of July 7th 2022. This medical study requires 120 volunteers between two sites."

Answered by AI

Does this clinical trial allow for participation from octogenarians?

"The eligibility criteria for this clinical trial specifies that participants must be between 18 and 45 years old. In addition, there are 3 studies intended to involve minors and a further 15 specifically targeted at seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I seem to be having worsening issues with my ocd especially around my period when I'm feeling more emotional and I'd really like some help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
2022. "How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359562.
All > Ocd New York > Ocd
~64 spots leftby Jun 2026
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