NCT01464398CompletedNot Applicable
Stress Reduction for PCOS and Non-PCOS Women
Milton S. Hershey Medical Center1 site in 1 country86 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women, age 18 years or older
- •Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)
Exclusion Criteria
- •Current pregnancy
- •Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin >30)
- •Untreated hypothyroidism or hyperthyroidism (defined as TSH <0.2 or >5.5 mIU/mL)
- •Severe active neuropsychological disorder such as psychosis or suicidal ideation
- •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.
- •History of an inpatient admission for psychiatric disorder within the past two years
- •Active alcohol or drug abuse
- •Inability to read, speak or write English
- •Inability to commit to the intervention and follow-up
- •Current enrollment in a stress reduction program
- •Mindfulness practice within the past 6 months (regular formal practice at least once a week)
- •Current enrollment in other investigative studies
- •Type 1 diabetes
Arms & Interventions
Stress reduction
Active Comparator
Mindfulness-based stress reduction
Intervention: Stress reduction (Behavioral)
Stress reduction with Health education
Active Comparator
General stress management and health education
Intervention: Stress reduction with Health education (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline in Toronto Mindfulness Scale at 8 weeks
Time Frame: baseline and 8 weeks
Secondary Outcomes
- Change from Baseline in Hemoglobin A1c at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Mean Arterial Pressure at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Brief Symptom Inventory-18 at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Toronto Mindfulness Scale at 16 weeks(baseline and 16 weeks)
- Change from Baseline in SF-36 at 16 weeks(baseline and 16 weeks)
- Change from Baseline in Mean Arterial Pressure at 8 weeks(baseline and 8 weeks)
- Change from Baseline in SF-36 at 8 weeks(baseline and 8 weeks)
- Change from Baseline in Brief Symptom Inventory-18 at 8 weeks(baseline and 8 weeks)
- Change from Baseline in Hemoglobin A1c at 8 weeks(baseline and 8 weeks)
Investigators
Nazia Raja-Khan
M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism
Milton S. Hershey Medical Center
Study Sites (1)
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