How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD

Part of paid clinical trials in New York, New York.

Sponsor
University of Pennsylvania
Study ID
NCT05359562
Status
Recruiting
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Conditions

  • OCD

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Exposure & Response Prevention (EX/RP) — BEHAVIORAL
    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.

Study Details

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.

Key Dates

Start date
Jun 15, 2022
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator
    Male participants will receive a brief EX/RP protocol within a 10-day window.
  • Experimental: 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).
  • Experimental: 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).

Primary Outcome Measure

fMRI [ Time Frame: Baseline to approximately 4 weeks later ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032
Hannah McManus
[email protected]
646-774-8062
Stephanie Grimaldi
[email protected]
646-774-8062
Helen B Simpson, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Bryanna Mackey, BA
[email protected]
215-746-3344
Jeremy Tyler, PsyD
[email protected]
215-746-3349
Edna B Foa, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
New York State Psychiatric Institute· New York, NYUniversity of Pennsylvania· Philadelphia, PA

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