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

Polycystic Ovary Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Polycystic Ovary Syndrome

Overweight

Obesity

Stress, Physiological

Stress, Psychological

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Stress reduction8 weekly sessions

Behavioral:Stress reduction with Health education8 weekly sessions

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Stress reductionMindfulness-based stress reduction

Stress reduction with Health educationGeneral stress management and health education

Study Status

Completed

Start Date: November 2011

Completed Date: June 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change from Baseline in Toronto Mindfulness Scale at 8 weeks

Secondary Outcome: Change from Baseline in Toronto Mindfulness Scale at 16 weeks

Study sponsors, principal investigator, and references

Principal Investigator: Nazia Raja-Khan, MD

Lead Sponsor: Milton S. Hershey Medical Center

Collaborator: National Center for Complementary and Integrative Health (NCCIH)

More information:https://clinicaltrials.gov/show/NCT01464398

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