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

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Nutrition Counseling
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring Polycystic Ovary Syndrome, PCOS, Depression, Anxiety, Weight loss, Exercise, Nutrition, Therapy, Mood symptoms, Stress

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Polycystic Ovary Syndrome (PCOS)
  • Overweight or obese (BMI 27-50)
  • Screen positive for symptoms of depression

Exclusion Criteria:

  • Smoking 5 or more cigarettes per day
  • Severe depression/anxiety warranting immediate treatment
  • Actively participating in a weight loss program
  • Taking medications to control cholesterol 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

Sites / Locations

  • Penn PCOS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CBT and Nutrition Counseling

Nutrition Counseling

Arm Description

8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling

16 weeks of Nutrition Counseling alone

Outcomes

Primary Outcome Measures

Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
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.
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.
Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST)

Full Information

First Posted
July 10, 2013
Last Updated
November 22, 2016
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01899001
Brief Title
Mood and Nutrition Interventions in Polycystic Ovary Syndrome
Acronym
MANI-PCOS
Official Title
Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)
Keywords
Polycystic Ovary Syndrome, PCOS, Depression, Anxiety, Weight loss, Exercise, Nutrition, Therapy, Mood symptoms, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT and Nutrition Counseling
Arm Type
Experimental
Arm Description
8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
Arm Title
Nutrition Counseling
Arm Type
Other
Arm Description
16 weeks of Nutrition Counseling alone
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counseling
Other Intervention Name(s)
Dietary Counseling, Exercise Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
Description
Changes in mood symptoms will be assessed using the CES-D, STAI, HRQOL
Time Frame
Baseline, Week 8, Week 16
Secondary Outcome Measure Information:
Title
Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
Description
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)
Time Frame
Baseline, Week 8, Week 16
Title
Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
Description
Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST)
Time Frame
Baseline, Week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Polycystic Ovary Syndrome (PCOS) Overweight or obese (BMI 27-50) Screen positive for symptoms of depression Exclusion Criteria: Smoking 5 or more cigarettes per day Severe depression/anxiety warranting immediate treatment Actively participating in a weight loss program Taking medications to control cholesterol 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuja Dokras, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn PCOS Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Mood and Nutrition Interventions in Polycystic Ovary Syndrome

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