Health TrialsbyHealthPanel

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

ConditionOCD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Pennsylvania

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Active ComparatorActive comparator 1 intervention
Group B: Experimental 1Experimental treatment 1 intervention
Group C: Experimental 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

fMRI

Slope of change in brain activation (fMRI)

Time frame
Baseline to approximately 4 weeks later
2

OCD Symptoms

Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)

Time frame
Baseline to approximately 4 weeks later

Secondary outcomes

1

rs fMRI

Slope of change in resting state functional connectivity (fMRI)

Time frame
Baseline to approximately 4 weeks later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

New York State Psychiatric Institute

Collaborator

New York University

Collaborator

Columbia University

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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