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

NCT05359562 | Recruiting DMC

• 2 other identifiers: 1R01MH121608-01A11R01MH121597-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

OCD

Keywords

OCD; Exposure and Ritual Prevention; Extinction Learning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• rs fMRI

  Baseline to approximately 4 weeks later

Study Arms (3)

Active Comparator

ACTIVE COMPARATOR

Male participants will receive a brief EX/RP protocol within a 10-day window.

Behavioral: Exposure & Response Prevention (EX/RP)

Experimental 1

EXPERIMENTAL

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)

Experimental 2

EXPERIMENTAL

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)

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.

Active Comparator; Experimental 1; Experimental 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
• Male and female subjects aged between 18- 45;
• Women must be menstruating and regularly cycling
• Ability to tolerate a treatment-free period;
• No psychotropic medication in the past 12 weeks
• At entry, at least moderate severity OCD
• Willingness and ability to give written informed consent after full explanation of study procedures.

You may not qualify if:

• Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
• Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
• Neurologic or medical condition that would prevent safe participation in the full study protocol.
• Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
• Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
• Patients with prominent suicidal ideation or with a recent suicide attempt.
• Current psychotherapy

Sponsors & Collaborators

• University of Pennsylvania: lead
• New York State Psychiatric Institute: collaborator
• New York University: collaborator
• Research Foundation for Mental Hygiene, Inc. / Columbia University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Edna B Foa, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Helen B Simpson, MD, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryanna Mackey

CONTACT

2157463344; Bryanna.Mackey@Pennmedicine.upenn.edu

Hannah McManus

CONTACT

6467748062; Hannah.McManus@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study hypotheses will be masked to participant, therapist, and outcome assessor. Assignment of women participants to groups will be masked to therapist, investigator, and outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 4, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (2)