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

Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD

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.

Study Overview

• Status: Recruiting
• Conditions: OCD
• Intervention / Treatment: Behavioral: Exposure & Response Prevention (EX/RP)

Detailed Description

This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryanna Mackey; Phone Number: 2157463344; Email: Bryanna.Mackey@Pennmedicine.upenn.edu
• Study Contact Backup: Name: Hannah McManus; Phone Number: 6467748062; Email: Hannah.McManus@nyspi.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Suspended
      • New York State Psychiatric Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Bryanna Mackey, BA; Phone Number: 215-746-3344; Email: Bryanna.Mackey@Pennmedicine.upenn.edu
      • Contact: Jeremy Tyler, PsyD; Phone Number: 215-746-3349; Email: jeremyty@pennmedicine.upenn.edu
      • Principal Investigator: Edna B Foa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
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:

1. Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; Male participants will receive a brief EX/RP protocol within a 10-day window.	Behavioral: 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: 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).	Behavioral: 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: 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).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI	Slope of change in brain activation (fMRI)	Baseline to approximately 4 weeks later
OCD Symptoms	Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)	Baseline to approximately 4 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rs fMRI	Slope of change in resting state functional connectivity (fMRI)	Baseline to approximately 4 weeks later

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH); New York University; New York State Psychiatric Institute; Research Foundation for Mental Hygiene, Inc.
• Investigators: Principal Investigator: Edna B Foa, PhD, University of Pennsylvania; Principal Investigator: Helen B Simpson, MD, PhD, New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: OCD; Extinction Learning; Exposure and Ritual Prevention
• Other Study ID Numbers: 1R01MH121608-01A1 (U.S. NIH Grant/Contract); 1R01MH121597-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No