Nazia Raja-Khan, M.D. is an endocrinologist with a long-term career goal of establishing an integrative medicine research program for Polycystic Ovary Syndrome (PCOS) aimed at integrating evidence-based non-conventional complementary therapies with conventional medical therapies for PCOS to optimize psychological and cardiometabolic health in PCOS. PCOS is a common endocrine disorder that affects 5-10% of reproductive-aged women. Women with PCOS are at increased risk for psychological distress, which may contribute to their increased risk for diabetes and cardiovascular disease. However, there is a lack of effective strategies for managing psychological distress in PCOS. Mindfulness-Based Stress Reduction (MBSR) reduces psychological distress in various patient populations and a pilot study showed that MBSR lowers glucose and blood pressure. Therefore, MBSR could significantly impact PCOS by reducing psychological distress and cardiometabolic risk;however, MBSR has not been investigated in PCOS. MBSR may have similar benefits for overweight or obese women who do not have PCOS (non-PCOS) as stress is also believed to play a major role in obesity. Our objective is to conduct a pilot randomized controlled trial investigating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese. Ninety eight (98) women will be randomized to 8-weeks of MBSR or health education control and followed for 16 weeks. The overall hypothesis is that MBSR will reduce cardiometabolic risk and psychological distress and improve quality of life in PCOS and non-PCOS women.
Specific Aims are to: 1) Determine the effects of MBSR compared to health education control on changes in mindfulness, primarily assessed with the Toronto Mindfulness Scale;2) Conduct a preliminary evaluation of the effects of MBSR compared to health education control on hemoglobin A1c, mean arterial pressure (MAP), quality of life, and overall psychological distress;3) Explore physiologic mechanisms potentially mediating the effects of MBSR, including salivary cortisol and insulin resistance measured by homeostasis model assessment (HOMA-IR). This career development award will provide Dr. Raja-Khan with the skills, experience, and preliminary data to develop a competitive R01 proposal to more comprehensively investigate the effects and mechanisms of MBSR in PCOS. This research will inform the development of novel integrative mind-body approaches for PCOS, diabetes, and cardiovascular disease.

Public Health Relevance

This research will begin to define the roles of mindfulness and psychological distress on cardiometabolic risk and quality of life in PCOS and non-PCOS women who are overweight or obese. As untreated psychological distress may contribute to the increased risk for type 2 diabetes and cardiovascular disease observed in these patient populations, developing effective strategies for the management of psychological distress in PCOS and non-PCOS women is critically important. Given the rising epidemic of diabetes and the fact that cardiovascular disease remains the major cause of mortality, this research may have broader public health implications regarding the prevention or reduction of diabetes and cardiovascular disease in the general population as well.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AT006340-03
Application #
8496724
Study Section
Special Emphasis Panel (ZAT1-PK (16))
Program Officer
Alekel, D Lee
Project Start
2011-09-01
Project End
2016-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$126,928
Indirect Cost
$9,402
Name
Pennsylvania State University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
129348186
City
Hershey
State
PA
Country
United States
Zip Code
17033