Skip to main content
OpenTrials
Completed

NCT Number: NCT01899001

Mood and Nutrition Interventions in Polycystic Ovary Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Anxiety Disorders Behavior Behavioral Symptoms Body Weight Body Weight Changes Cysts Depression Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Mental Disorders Motor Activity Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn PCOS Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Nutrition counseling

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS

Acronym: MANI-PCOS

Important dates

Study start
2013
Primary completion
2016
First posted
Jul 15, 2013
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.