Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)

• Change from Baseline in Toronto Mindfulness Scale at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Hemoglobin A1c at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Hemoglobin A1c at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Mean Arterial Pressure at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Mean Arterial Pressure at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in SF-36 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in SF-36 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

• Change from Baseline in Toronto Mindfulness Scale at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Hemoglobin A1c at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Hemoglobin A1c at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Mean Arterial Pressure at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Mean Arterial Pressure at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in PCOS Quality of Life at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in PCOS Quality of Life at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Brief Symptom Inventory-18 at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Brief Symptom Inventory-18 at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.

• Polycystic Ovary Syndrome
• Overweight
• Obesity
• Stress, Physiological
• Stress, Psychological

• Behavioral: Stress reduction
  8 weekly sessions
• Behavioral: Stress reduction with Health education
  8 weekly sessions

• Active Comparator: Stress reduction
  Intervention: Behavioral: Stress reduction
• Active Comparator: Stress reduction with Health education
  Intervention: Behavioral: Stress reduction with Health education

Inclusion Criteria:

1. Women, age 18 years or older
2. Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)

Exclusion criteria:

1. Current pregnancy
2. Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
3. Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
4. Severe active neuropsychological disorder such as psychosis or suicidal ideation
5. Severe untreated depression or anxiety. Women with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study.
6. History of an inpatient admission for psychiatric disorder within the past two years
7. Active alcohol or drug abuse
8. Inability to read, speak or write English
9. Inability to commit to the intervention and follow-up
10. Current enrollment in a stress reduction program
11. Mindfulness practice within the past 6 months (regular formal practice at least once a week)
12. Current enrollment in other investigative studies
13. Type 1 diabetes

• National Center for Complementary and Alternative Medicine (NCCAM)
• Thomas Jefferson University