How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
NCT ID: NCT05359562
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-06-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Comparator
Male participants will receive a brief EX/RP protocol within a 10-day window.
Exposure & Response Prevention (EX/RP)
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.
Experimental 1
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).
Exposure & Response Prevention (EX/RP)
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.
Experimental 2
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).
Exposure & Response Prevention (EX/RP)
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.
Interventions
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Exposure & Response Prevention (EX/RP)
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.
Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects aged between 18- 45;
3. Women must be menstruating and regularly cycling
4. Ability to tolerate a treatment-free period;
5. No psychotropic medication in the past 12 weeks
6. At entry, at least moderate severity OCD
7. Willingness and ability to give written informed consent after full explanation of study procedures.
Exclusion Criteria
2. Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
3. Neurologic or medical condition that would prevent safe participation in the full study protocol.
4. Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
5. Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
6. Patients with prominent suicidal ideation or with a recent suicide attempt.
7. Current psychotherapy
18 Years
45 Years
ALL
No
Sponsors
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New York State Psychiatric Institute
OTHER
New York University
OTHER
Research Foundation for Mental Hygiene, Inc. / Columbia University
UNKNOWN
National Institute of Mental Health (NIMH)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Edna B Foa, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Helen B Simpson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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New York State Psychiatric Institute
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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