Treating PCOS With Digital CBT vs. Metformin

Treating Polycystic Ovarian Syndrome (PCOS) With Digital Cognitive Behavior Therapy (CBT) vs. Metformin

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Behavioral: Digital Cognitive Behavioral Therapy; Drug: Metformin

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manna Zhang, Doctor; Phone Number: +86-021-66301004; Email: mannazhang@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Department of Endocrinology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Digital CBT
Active Comparator: Metformin; Traditional metformin monotherapy.	Drug: Metformin; Traditional metformin monotherapy.; Other Names: Metformin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homeostasis model assessment of insulin resistance	insulin resistance index	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	body mass index (kg/m2)	3 months
menstrual frequency	number of menstruation in a year	3 months
fasting glucose	fasting glucose（mmol/L)	3 months
fasting insulin	fasting insulin（mmol/L)	3 months
Total cholesterol	Total cholesterol (mmol/L)	3 months
Triglycerides	Triglycerides (mmol/L)	3 months
HDL-c	HDL-c (mmol/L)	3 months
LDL-c	LDL-c (mmol/L)	3 months
total testosterone	total testosterone (nmol/L)	3 months
free testosterone	free testosterone (nmol/L)	3 months
Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	3 months
Androstenedione	Androstenedione (ng/ml)	3 months
Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	3 months
Food Frequency Questionnaire (FFQ)	Assess diet situation in women with PCOS.	3 months
International Physical Activity Questionnaire (IPAQ)	Assess physical activity situation in women with PCOS.	3 months
Pittsburgh Sleep Quality Index (PSQI)	Assess sleep situation in women with PCOS.	3 months
Hospital Anxiety and Depression Scale (HADS)	To evaluate anxiety and depression in PCOS women.	3 months
Three-Factor Eating Questionnaire (TFEQ-R21)	Assess eating behavior in women with PCOS.	3 months

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Shen Qu, Doctor, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): August 12, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: dCBT PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No