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

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University of Pennsylvania

Status

Completed

Conditions

Polycystic Ovary Syndrome (PCOS)

Treatments

Behavioral: Nutrition Counseling
Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

CBT and Nutrition Counseling
Experimental group
Description:
8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
Treatment:
Behavioral: Cognitive Behavioral Therapy
Behavioral: Nutrition Counseling
Nutrition Counseling
Other group
Description:
16 weeks of Nutrition Counseling alone
Treatment:
Behavioral: Nutrition Counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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