Treating PCOS With Digital CBT vs. Metformin

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior change in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. Besides, cognitive behavioral therapy plays an important role in managing and maintaining a healthy lifestyle. This study aimed to investigate the efficacy of digital cognitive behavioral therapy versus traditional metformin monotherapy in overweight/obese patients with PCOS.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai 10th People's Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

Female aged 18- 45; Meet Rotterdam criteria; overweight/obesity, BMI≥23kg/m2

Exclusion Criteria:

Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and contraceptives in the last 3 months.