Mood and Nutrition Interventions in Polycystic Ovary Syndrome (MANI-PCOS)

University of Pennsylvania

Status: Completed

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Behavioral: Nutrition Counseling; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01899001

818103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Polycystic Ovary Syndrome (PCOS)
• Overweight or obese (BMI 27-50)
• Screen positive for symptoms of depression

Exclusion criteria

• Smoking 5 or more cigarettes per day
• Severe depression/anxiety warranting immediate treatment
• Actively participating in a weight loss program
• Taking medications to control cholesterol or diabetes
• On hormonal therapy (must be discontinued to be eligible)
• Pregnancy or planning to become pregnant during the study period
• Inability to commute to Philadelphia for weekly study sessions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CBT and Nutrition Counseling

Experimental group

Description:

8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling

Treatment:

Behavioral: Cognitive Behavioral Therapy

Behavioral: Nutrition Counseling

Nutrition Counseling

Other group

Description:

16 weeks of Nutrition Counseling alone

Treatment:

Behavioral: Nutrition Counseling