Laura G Cooney1, Lauren W Milman1, Liisa Hantsoo2, Sara Kornfield2, Mary D Sammel3, Kelly C Allison2, C Neill Epperson2, Anuja Dokras4. 1. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, Philadelphia, Pennsylvania. 4. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: adokras@obgyn.upenn.edu.
Abstract
OBJECTIVE: To compare the effects of cognitive-behavioral therapy (CBT) and lifestyle modification (LS) versus LS alone on weight, depressive and anxiety symptoms, and stress response in women with polycystic ovary syndrome (PCOS), overweight/obesity, and depressive symptoms. DESIGN: A 16-week pilot randomized clinical trial. SETTING: Tertiary-care PCOS center. PATIENT(S): Overweight/obese women with PCOS and depressive symptoms. INTERVENTION(S): Weekly CBT (n = 7) or contact only/no therapy (n = 8) for 8 weeks. Both groups received weekly LS for 16 weeks. MAIN OUTCOME MEASURE(S): Changes in weight, depression (Center for Epidemiologic Studies Depression Scale [CES-D]), anxiety (State-Trait Anxiety Inventory [STAI]), quality of life (Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire [PCOSQ]), laboratory tests, and response to a Trier Social Stress Test (TSST). RESULT(S): The CBT+LS group lost more weekly weight (-0.35 kg/wk vs. -0.16 kg/wk) compared with the LS group. Overall, the CBT+LS group lost 3.2 kg versus 1.8 kg for the LS group. The CBT+LS group had greater improvement in PCOSQ at 8 weeks (+3.7 vs. +1.2 points). In the overall cohort, STAI and CES-D decreased by -0.27 points per week and -0.31 points/wk, respectfully, and total and free T decreased at week 8. Heart rate response to TSST was lower at 15 minutes after stressor in the CBT+LS group. CONCLUSION(S): Weekly CBT+LS for 8 weeks compared with LS alone resulted in significant weight loss and improved quality of life in overweight/obese women with PCOS and depressive symptoms. These interventions were associated with a decreased autonomic response to a laboratory stressor, suggesting a potential link between CBT, weight loss, and modulation of the stress response. CLINICAL TRIAL REGISTRATION NUMBER: NCT01899001.
RCT Entities:
OBJECTIVE: To compare the effects of cognitive-behavioral therapy (CBT) and lifestyle modification (LS) versus LS alone on weight, depressive and anxiety symptoms, and stress response in women with polycystic ovary syndrome (PCOS), overweight/obesity, and depressive symptoms. DESIGN: A 16-week pilot randomized clinical trial. SETTING: Tertiary-care PCOS center. PATIENT(S): Overweight/obesewomen with PCOS and depressive symptoms. INTERVENTION(S): Weekly CBT (n = 7) or contact only/no therapy (n = 8) for 8 weeks. Both groups received weekly LS for 16 weeks. MAIN OUTCOME MEASURE(S): Changes in weight, depression (Center for Epidemiologic Studies Depression Scale [CES-D]), anxiety (State-Trait Anxiety Inventory [STAI]), quality of life (Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire [PCOSQ]), laboratory tests, and response to a Trier Social Stress Test (TSST). RESULT(S): The CBT+LS group lost more weekly weight (-0.35 kg/wk vs. -0.16 kg/wk) compared with the LS group. Overall, the CBT+LS group lost 3.2 kg versus 1.8 kg for the LS group. The CBT+LS group had greater improvement in PCOSQ at 8 weeks (+3.7 vs. +1.2 points). In the overall cohort, STAI and CES-D decreased by -0.27 points per week and -0.31 points/wk, respectfully, and total and free T decreased at week 8. Heart rate response to TSST was lower at 15 minutes after stressor in the CBT+LS group. CONCLUSION(S): Weekly CBT+LS for 8 weeks compared with LS alone resulted in significant weight loss and improved quality of life in overweight/obesewomen with PCOS and depressive symptoms. These interventions were associated with a decreased autonomic response to a laboratory stressor, suggesting a potential link between CBT, weight loss, and modulation of the stress response. CLINICAL TRIAL REGISTRATION NUMBER: NCT01899001.
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