Mood and Nutrition Interventions in Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome (PCOS)
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Nutrition Counseling

• Registration Number: NCT01899001
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Primary Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT and Nutrition Counseling	Nutrition Counseling	8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
CBT and Nutrition Counseling	Cognitive Behavioral Therapy	8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
Nutrition Counseling	Nutrition Counseling	16 weeks of Nutrition Counseling alone

Primary Outcome Measures

Name	Time	Method
Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.	Baseline, Week 8, Week 16	Changes in mood symptoms will be assessed using the CES-D, STAI, HRQOL

Secondary Outcome Measures

Name	Time	Method
Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.	Baseline, Week 8	Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST)
Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.	Baseline, Week 8, Week 16	Changes in cardio metabolic risk factors will be assessed using clinical parameters (blood pressure, waist circumference, BMI) and serum parameters (lipid profile, fasting glucose, insulin, total testosterone, free testosterone, sex hormone binding globulin, Apo A1, Apo B, hsCRP, IL-6)

Trial Locations

Locations (1)

Penn PCOS Center; 🇺🇸 Philadelphia, Pennsylvania, United States