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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05359562

Enrollment

120

Registered

2022-05-04

Start date

2022-06-15

Completion date

2028-06-30

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OCD

Keywords

OCD, Exposure and Ritual Prevention, Extinction Learning

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.

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.

Interventions

BEHAVIORALExposure & 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTBryanna Mackey

Bryanna.Mackey@Pennmedicine.upenn.edu2157463344

CONTACTSara Rose Shannon, BS, MS

SaraRose.Shannon@nyspi.columbia.edu6467748082

PRINCIPAL_INVESTIGATORLily Brown, PhD

University of Pennsylvania

PRINCIPAL_INVESTIGATORHelen B Simpson, MD, PhD

New York State Psychiatric Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026