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
University of Pennsylvania
120 participants
Jun 15, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria7
- 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
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05359562