Mood and Nutrition Interventions in Polycystic Ovary Syndrome

NCT01899001 | Completed

• 1 other identifier: 818103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome; PCOS; Depression; Anxiety; Weight loss; Exercise; Nutrition; Therapy; Mood symptoms; Stress

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 8, Week 16

Secondary Outcomes (2)

• Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.

  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.

  Baseline, Week 8

Study Arms (2)

CBT and Nutrition Counseling

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy; Behavioral: Nutrition Counseling

Nutrition Counseling

OTHER

16 weeks of Nutrition Counseling alone

Behavioral: Nutrition Counseling

Interventions

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.

Also known as: CBT

CBT and Nutrition Counseling

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.

Also known as: Dietary Counseling, Exercise Counseling

CBT and Nutrition Counseling; Nutrition Counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn PCOS Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (25)

• Dokras A, Clifton S, Futterweit W, Wild R. Increased risk for abnormal depression scores in women with polycystic ovary syndrome: a systematic review and meta-analysis. Obstet Gynecol. 2011 Jan;117(1):145-152. doi: 10.1097/AOG.0b013e318202b0a4.

  PMID: 21173657 BACKGROUND

• Dokras A, Clifton S, Futterweit W, Wild R. Increased prevalence of anxiety symptoms in women with polycystic ovary syndrome: systematic review and meta-analysis. Fertil Steril. 2012 Jan;97(1):225-30.e2. doi: 10.1016/j.fertnstert.2011.10.022. Epub 2011 Nov 27.

  PMID: 22127370 BACKGROUND

• Hollinrake E, Abreu A, Maifeld M, Van Voorhis BJ, Dokras A. Increased risk of depressive disorders in women with polycystic ovary syndrome. Fertil Steril. 2007 Jun;87(6):1369-76. doi: 10.1016/j.fertnstert.2006.11.039. Epub 2007 Mar 29.

  PMID: 17397839 BACKGROUND

• Wild RA, Carmina E, Diamanti-Kandarakis E, Dokras A, Escobar-Morreale HF, Futterweit W, Lobo R, Norman RJ, Talbott E, Dumesic DA. Assessment of cardiovascular risk and prevention of cardiovascular disease in women with the polycystic ovary syndrome: a consensus statement by the Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society. J Clin Endocrinol Metab. 2010 May;95(5):2038-49. doi: 10.1210/jc.2009-2724. Epub 2010 Apr 7.

  PMID: 20375205 BACKGROUND

• Kelly CC, Lyall H, Petrie JR, Gould GW, Connell JM, Sattar N. Low grade chronic inflammation in women with polycystic ovarian syndrome. J Clin Endocrinol Metab. 2001 Jun;86(6):2453-5. doi: 10.1210/jcem.86.6.7580.

  PMID: 11397838 BACKGROUND

• Boulman N, Levy Y, Leiba R, Shachar S, Linn R, Zinder O, Blumenfeld Z. Increased C-reactive protein levels in the polycystic ovary syndrome: a marker of cardiovascular disease. J Clin Endocrinol Metab. 2004 May;89(5):2160-5. doi: 10.1210/jc.2003-031096.

  PMID: 15126536 BACKGROUND

• Toulis KA, Goulis DG, Farmakiotis D, Georgopoulos NA, Katsikis I, Tarlatzis BC, Papadimas I, Panidis D. Adiponectin levels in women with polycystic ovary syndrome: a systematic review and a meta-analysis. Hum Reprod Update. 2009 May-Jun;15(3):297-307. doi: 10.1093/humupd/dmp006. Epub 2009 Mar 4.

  PMID: 19261627 BACKGROUND

• Shroff R, Kerchner A, Maifeld M, Van Beek EJ, Jagasia D, Dokras A. Young obese women with polycystic ovary syndrome have evidence of early coronary atherosclerosis. J Clin Endocrinol Metab. 2007 Dec;92(12):4609-14. doi: 10.1210/jc.2007-1343. Epub 2007 Sep 11.

  PMID: 17848406 BACKGROUND

• Rozanski A, Blumenthal JA, Kaplan J. Impact of psychological factors on the pathogenesis of cardiovascular disease and implications for therapy. Circulation. 1999 Apr 27;99(16):2192-217. doi: 10.1161/01.cir.99.16.2192.

  PMID: 10217662 BACKGROUND

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  PMID: 15364185 BACKGROUND

• Ferketich AK, Schwartzbaum JA, Frid DJ, Moeschberger ML. Depression as an antecedent to heart disease among women and men in the NHANES I study. National Health and Nutrition Examination Survey. Arch Intern Med. 2000 May 8;160(9):1261-8. doi: 10.1001/archinte.160.9.1261.

  PMID: 10809028 BACKGROUND

• Rutledge T, Linke SE, Krantz DS, Johnson BD, Bittner V, Eastwood JA, Eteiba W, Pepine CJ, Vaccarino V, Francis J, Vido DA, Merz CN. Comorbid depression and anxiety symptoms as predictors of cardiovascular events: results from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) study. Psychosom Med. 2009 Nov;71(9):958-64. doi: 10.1097/PSY.0b013e3181bd6062. Epub 2009 Oct 15.

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• Roest AM, Martens EJ, de Jonge P, Denollet J. Anxiety and risk of incident coronary heart disease: a meta-analysis. J Am Coll Cardiol. 2010 Jun 29;56(1):38-46. doi: 10.1016/j.jacc.2010.03.034.

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• Fagundes CP, Glaser R, Hwang BS, Malarkey WB, Kiecolt-Glaser JK. Depressive symptoms enhance stress-induced inflammatory responses. Brain Behav Immun. 2013 Jul;31:172-6. doi: 10.1016/j.bbi.2012.05.006. Epub 2012 May 22.

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• Kerchner A, Lester W, Stuart SP, Dokras A. Risk of depression and other mental health disorders in women with polycystic ovary syndrome: a longitudinal study. Fertil Steril. 2009 Jan;91(1):207-12. doi: 10.1016/j.fertnstert.2007.11.022. Epub 2008 Feb 4.

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• Azziz R, Marin C, Hoq L, Badamgarav E, Song P. Health care-related economic burden of the polycystic ovary syndrome during the reproductive life span. J Clin Endocrinol Metab. 2005 Aug;90(8):4650-8. doi: 10.1210/jc.2005-0628. Epub 2005 Jun 8.

  PMID: 15944216 BACKGROUND

• Moran LJ, Pasquali R, Teede HJ, Hoeger KM, Norman RJ. Treatment of obesity in polycystic ovary syndrome: a position statement of the Androgen Excess and Polycystic Ovary Syndrome Society. Fertil Steril. 2009 Dec;92(6):1966-82. doi: 10.1016/j.fertnstert.2008.09.018. Epub 2008 Dec 4.

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• Cooney LG, Milman LW, Hantsoo L, Kornfield S, Sammel MD, Allison KC, Epperson CN, Dokras A. Cognitive-behavioral therapy improves weight loss and quality of life in women with polycystic ovary syndrome: a pilot randomized clinical trial. Fertil Steril. 2018 Jul 1;110(1):161-171.e1. doi: 10.1016/j.fertnstert.2018.03.028. Epub 2018 Jun 13.

  PMID: 29908771 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Depression; Anxiety Disorders; Weight Loss; Motor Activity

Interventions

Cognitive Behavioral Therapy; Nutrition Assessment

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Anuja Dokras, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

US (1)