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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH121597-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York State Psychiatric Institute | OTHER |
| New York University | OTHER |
| Columbia University | OTHER |
| National Institute of Mental Health (NIMH) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Active Comparator | Male participants will receive a brief EX/RP protocol within a 10-day window. |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| rs fMRI | Slope of change in resting state functional connectivity (fMRI) | Baseline to approximately 4 weeks later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryanna Mackey | Contact | 2157463344 | Bryanna.Mackey@Pennmedicine.upenn.edu | |
| Hannah McManus | Contact | 6467748062 | Hannah.McManus@nyspi.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lily Brown, PhD | University of Pennsylvania | Principal Investigator |
| Helen B Simpson, MD, PhD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | Recruiting | New York | New York | 10032 | United States |
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| NIH |
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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.
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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