Clinical trial NCT01899001: Mood and Nutrition Interventions in Polycystic Ovary Syndrome
Official title: Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: Polycystic Ovary Syndrome
PCOS
Depression
Anxiety
Weight loss
Exercise
Nutrition
Therapy
Mood symptoms
Stress
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
timeFrame: Baseline, Week 8, Week 16
Secondary outcomes:
measure: Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
timeFrame: Baseline, Week 8, Week 16
measure: Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn PCOS Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anuja Dokras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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