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Spots Global Cancer Trial Database for Mood and Nutrition Interventions in Polycystic Ovary Syndrome

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Trial Identification

Brief Title: Mood and Nutrition Interventions in Polycystic Ovary Syndrome

Official Title: Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS

Study ID: NCT01899001

Study Description

Brief Summary: The purpose of this study is to help determine the best treatment plan for women with PCOS who are overweight or obese and experiencing significant symptoms of depression and anxiety. Specifically, the investigators are attempting to see if there is a difference between cognitive behavioral therapy in combination with nutritional counseling in improving mood symptoms, response to stress, and risk factors for heart disease compared to nutrition counseling alone. The investigators hypothesize that combined treatment with Cognitive Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.

Detailed Description: This study will assess the impact of treatment of mood and associated anxiety disorders in conjunction with nutritional/exercise counseling in overweight/obese women with PCOS on cardiometabolic risk. The investigators hypothesize that women with PCOS will have greater benefit from dual intervention (psychological and nutritional/exercise counseling) for change in depressive symptoms and cardiometabolic risk reduction compared to nutritional/exercise counseling alone. In addition, the investigators hypothesize that psychological counseling may improve cardiometabolic risk by decreasing stress responses and stress associated markers of inflammation.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Penn PCOS Center, Philadelphia, Pennsylvania, United States

Contact Details

Name: Anuja Dokras, MD, PhD

Affiliation: University of Pennsylvania

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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