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

November 22, 2016 updated by: University of Pennsylvania

Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn PCOS Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Changes in mood symptoms will be assessed using the CES-D, STAI, HRQOL
Baseline, Week 8, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Baseline, Week 8, Week 16
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
Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST)
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Anuja Dokras, MD, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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