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Stress Reduction for PCOS and Non-PCOS Women


N/A
18 Years
N/A
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Overweight, Obesity, Stress, Physiological, Stress, Psychological

Thank you

Trial Information

Stress Reduction for PCOS and Non-PCOS Women


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Toronto Mindfulness Scale at 8 weeks

Outcome Time Frame:

baseline and 8 weeks

Safety Issue:

No

Principal Investigator

Nazia Raja-Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pennsylvania State University College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

34145EP

NCT ID:

NCT01464398

Start Date:

December 2011

Completion Date:

December 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Overweight
  • Obesity
  • Stress, Physiological
  • Stress, Psychological
  • Polycystic Ovary Syndrome
  • stress
  • mindfulness
  • meditation
  • health education
  • women
  • overweight
  • obesity
  • Obesity
  • Polycystic Ovary Syndrome
  • Stress, Psychological
  • Overweight

Name

Location

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033