Mood and Nutrition Interventions in Polycystic Ovary Syndrome (MANI-PCOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Anuja Dokras, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01899001
First received: July 10, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to help determine the best treatment plan for women with PCOS who are overweight or obese and experiencing significant symptoms of depression and anxiety.

Specifically, the investigators are attempting to see if there is a difference between cognitive behavioral therapy in combination with nutritional counseling in improving mood symptoms, response to stress, and risk factors for heart disease compared to nutrition counseling alone. The investigators hypothesize that combined treatment with Cognitive Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.


Condition Intervention
Polycystic Ovary Syndrome (PCOS)
Behavioral: Cognitive Behavioral Therapy
Behavioral: Nutrition Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone. [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
    Changes in mood symptoms will be assessed using the CES-D, STAI, HRQOL


Secondary Outcome Measures:
  • Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone. [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
    Changes in cardio metabolic risk factors will be assessed using clinical parameters (blood pressure, waist circumference, BMI) and serum parameters (lipid profile, fasting glucose, insulin, total testosterone, free testosterone, sex hormone binding globulin, Apo A1, Apo B, hsCRP, IL-6)

  • Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone. [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST)


Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT and Nutrition Counseling
8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
Behavioral: Cognitive Behavioral Therapy
Participants will receive weekly, 30 minute sessions with a CBT-trained clinical psychologist for the first 8 weeks. Briefly, the purpose of CBT is to treat mood and associated anxiety disorders by changing dysfunctional thoughts that lead to negative mood states and maladaptive behaviors. Through the use of Socratic questioning, the therapist challenges the patient to observe the relationship between thoughts and feelings and to question the underlying beliefs that perpetuate negative affect. Ultimately, patients learns to recognize maladaptive automatic thoughts and develop a more rational and balanced way of thinking about themselves and the world around them.
Other Name: CBT
Behavioral: Nutrition Counseling
All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.
Other Names:
  • Dietary Counseling
  • Exercise Counseling
Nutrition Counseling
16 weeks of Nutrition Counseling alone
Behavioral: Nutrition Counseling
All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.
Other Names:
  • Dietary Counseling
  • Exercise Counseling

Detailed Description:

This study will assess the impact of treatment of mood and associated anxiety disorders in conjunction with nutritional/exercise counseling in overweight/obese women with PCOS on cardiometabolic risk. The investigators hypothesize that women with PCOS will have greater benefit from dual intervention (psychological and nutritional/exercise counseling) for change in depressive symptoms and cardiometabolic risk reduction compared to nutritional/exercise counseling alone. In addition, the investigators hypothesize that psychological counseling may improve cardiometabolic risk by decreasing stress responses and stress associated markers of inflammation.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Polycystic Ovary Syndrome (PCOS)
  • Overweight or obese (BMI 27-45)
  • Screen positive for symptoms of depression

Exclusion Criteria:

  • Smoking 5 or more cigarettes per day
  • Currently in treatment for mood or anxiety disorders
  • Severe depression/anxiety warranting immediate treatment
  • Actively participating in a weight loss program
  • Taking medications to control cholesterol, high blood pressure, or diabetes
  • On hormonal therapy (must be discontinued to be eligible)
  • Pregnancy or planning to become pregnant during the study period
  • Inability to commute to Philadelphia for weekly study sessions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899001

Contacts
Contact: Molly Ruben, MPH 215-662-7727 mani.pcos@gmail.com

Locations
United States, Pennsylvania
Penn PCOS Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Anuja Dokras, MD, PhD         
Sub-Investigator: Lauren W Milman, MD         
Sub-Investigator: David Sarwer, PhD         
Sub-Investigator: C Neill Epperson, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Anuja Dokras, MD, PhD University of Pennsylvania
  More Information

Publications:

Responsible Party: Anuja Dokras, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01899001     History of Changes
Other Study ID Numbers: 818103
Study First Received: July 10, 2013
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Polycystic Ovary Syndrome
PCOS
Depression
Anxiety
Weight loss
Exercise
Nutrition
Therapy
Mood symptoms
Stress

Additional relevant MeSH terms:
Cardiovascular Diseases
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014