Mood and Nutrition Interventions in Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome (PCOS)

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Nutrition Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT and Nutrition Counseling<br>8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling | Behavioral: Cognitive Behavioral Therapy<br>* Participants will receive weekly, 30 minute sessions with a CBT-trained clinical psychologist for the first 8 weeks. Briefly, the purpose of CBT is to treat mood and associated anxiety disorders by changing dysfunctional thoughts that lead to negative mood states and maladaptive behaviors. Through the use of Socratic questioning, the therapist challenges the patient to observe the relationship between thoughts and feelings and to question the underlying beliefs that perpetuate negative affect. Ultimately, patients learns to recognize maladaptive automatic thoughts and develop a more rational and balanced way of thinking about themselves and the world around them.<br>* Other names: CBT;Behavioral: Nutrition Counseling<br>* All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.<br>* Other names: Exercise Counseling;|
| Other: Nutrition Counseling<br>16 weeks of Nutrition Counseling alone | Behavioral: Nutrition Counseling<br>* All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.<br>* Other names: Exercise Counseling;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone. | 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) | Baseline, Week 8, Week 16 | 
| Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone. | Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST) | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, PCOS, Depression, Anxiety, Weight loss, Exercise, Nutrition, Therapy, Mood symptoms, Stress