Clinical trial · Interventional
Mood and Nutrition Interventions in Polycystic Ovary Syndrome
Improving Psychological Health and Cardiovascular Disease Risk in Women With PCOS
NCT01899001CI-TRIAL-00024879MANI-PCOScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Nutrition Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBT and Nutrition Counseling
- description
- 8 weeks of Cognitive Behavioral Therapy (CBT) and 16 weeks of Nutrition Counseling
- interventionNames
- Behavioral: Cognitive Behavioral Therapy
- Behavioral: Nutrition Counseling
- type
- OTHER
- label
- Nutrition Counseling
- description
- 16 weeks of Nutrition Counseling alone
- interventionNames
- Behavioral: Nutrition Counseling
Primary outcomes (1)
- measure
- Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (25)
- BACKGROUNDDokras 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
- BACKGROUNDDokras 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
- BACKGROUNDHollinrake 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
- BACKGROUNDWild 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
- BACKGROUNDKelly 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
- BACKGROUNDBoulman 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
- BACKGROUNDToulis 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.