RECRUITING

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

Conditions

OCD Exposure and Ritual Prevention Extinction Learning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-15

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05359562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Bryanna Mackey

CONTACT

2157463344

Bryanna.Mackey@Pennmedicine.upenn.edu

Hannah McManus

CONTACT

6467748062

Hannah.McManus@nyspi.columbia.edu

Principal Investigator

Edna B Foa, PhD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Helen B Simpson, MD, PhD

PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Study Locations (Sites)

New York State Psychiatric Institute

New York, New York, 10032

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Edna B Foa, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
Helen B Simpson, MD, PhD, PRINCIPAL_INVESTIGATOR, New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15

Study Completion Date2026-06

Study Record Updates