Treating PCOS With Digital CBT vs. Metformin
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Based on the cognitive-behavioral therapy (CBT) model, this study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digital Cognitive Behavioural Therapy A mini program-based cognitive behavioral therapy. |
Behavioral: Digital Cognitive Behavioral Therapy
Based on the cognitive-behavioral therapy (CBT) model, this study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
Other Names:
|
| Active Comparator: Metformin Traditional metformin monotherapy. |
Drug: Metformin
Traditional metformin monotherapy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Homeostasis model assessment of insulin resistance [3 months]
insulin resistance index
Secondary Outcome Measures
- Anthropometry [3 months]
body mass index (kg/m2)
- menstrual frequency [3 months]
number of menstruation in a year
- fasting glucose [3 months]
fasting glucose（mmol/L)
- fasting insulin [3 months]
fasting insulin（mmol/L)
- Total cholesterol [3 months]
Total cholesterol (mmol/L)
- Triglycerides [3 months]
Triglycerides (mmol/L)
- HDL-c [3 months]
HDL-c (mmol/L)
- LDL-c [3 months]
LDL-c (mmol/L)
- total testosterone [3 months]
total testosterone (nmol/L)
- free testosterone [3 months]
free testosterone (nmol/L)
- Sex hormone-binding globulin [3 months]
Sex hormone-binding globulin (nmol/L)
- Androstenedione [3 months]
Androstenedione (ng/ml)
- Dehydroepiandrosterone [3 months]
Dehydroepiandrosterone (ug/dl)
- Food Frequency Questionnaire (FFQ) [3 months]
Assess diet situation in women with PCOS.
- International Physical Activity Questionnaire (IPAQ) [3 months]
Assess physical activity situation in women with PCOS.
- Pittsburgh Sleep Quality Index (PSQI) [3 months]
Assess sleep situation in women with PCOS.
- Hospital Anxiety and Depression Scale (HADS) [3 months]
To evaluate anxiety and depression in PCOS women.
- Three-Factor Eating Questionnaire (TFEQ-R21) [3 months]
Assess eating behavior in women with PCOS.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
- Study Chair: Shen Qu, Doctor, Shanghai 10th People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- dCBT PCOS