Actively Recruiting
Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
Led by University of Pennsylvania · Updated on 2025-10-07
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
New York State Psychiatric Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how hormones influence the brain's fear extinction network, which is important for exposure and response prevention (EX/RP), a key treatment for obsessive compulsive disorder (OCD). This study aims to understand how delivering EX/RP during different phases of the menstrual cycle affects brain function and OCD symptoms in women, while also exploring sex differences by including men. The goal is to improve and personalize EX/RP therapy for people with OCD. Participants will undergo neuroimaging, hormonal tests, and symptom assessments before and after a brief EX/RP treatment consisting of eight sessions, including two psychoeducation/planning sessions and six exposure sessions. Male participants will receive the brief EX/RP within a 10-day window. Female participants will be randomly assigned to receive EX/RP either in the early follicular phase (first 10 days after menstruation begins) or in the late follicular to early luteal phase (days 12-22 of the menstrual cycle). This design allows researchers to evaluate how hormonal changes affect treatment outcomes. Throughout the study, participants will have brain scans using fMRI and resting-state fMRI, along with OCD symptom ratings at the start and about four weeks later. The study also includes monitoring of hormonal levels. The research team will assess changes in brain activity related to fear extinction and OCD symptoms to better understand treatment mechanisms. Participants must be able to tolerate a treatment-free period and provide informed consent. The total participation duration covers baseline and follow-up assessments approximately four weeks apart.
CONDITIONS
Brief Title
How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of OCD according to DSM-5
- Male or female aged 18 to 45 years
- Women must be menstruating regularly
- Ability to tolerate a period without treatment
- No use of psychotropic medication in the past 12 weeks
- At least moderate severity of OCD at study entry
- Willing and able to provide written informed consent
You will not qualify if you...
- Use of hormonal birth control or IUD affecting menstrual cycle, or menopause
- Pregnancy or intention to become pregnant during the study
- Neurologic or medical conditions preventing safe study participation
- Contraindications to MRI, such as metallic implants or devices
- Comorbid psychiatric conditions that increase risk or confound results
- Prominent suicidal thoughts or recent suicide attempt
- Current psychotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within a 10-day window
Participants receive a brief course of Exposure and Response Prevention (EX/RP) therapy consisting of 8 sessions including psychoeducation and exposure sessions. Female participants are randomized to receive treatment during specific phases of their menstrual cycle.
8 therapy sessions over approximately 10 days
Duration - Approximately 4 weeks from baseline
Participants complete neuroimaging, hormonal assays, and symptom ratings before and after the brief EX/RP treatment to assess treatment response.
2 visits (pre- and post-treatment assessments)
Trial Site Locations
Total: 2 locations
1
New York State Psychiatric Institute
New York, New York, United States, 10032
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
B
Bryanna Mackey
H
Hannah McManus
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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