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Treating PCOS With Digital CBT vs. Metformin

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Digital Cognitive Behavioral Therapy
Metformin
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Endocrinology, Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Cognitive Behavioural Therapy

Metformin

Arm Description

A mini program-based cognitive behavioral therapy.

Traditional metformin monotherapy.

Outcomes

Primary Outcome Measures

Homeostasis model assessment of insulin resistance
insulin resistance index

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2022
Last Updated
October 19, 2023
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05386706
Brief Title
Treating PCOS With Digital CBT vs. Metformin
Official Title
Treating Polycystic Ovarian Syndrome (PCOS) With Digital Cognitive Behavior Therapy (CBT) vs. Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
August 12, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
A mini program-based cognitive behavioral therapy.
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Traditional metformin monotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Digital Cognitive Behavioral Therapy
Other Intervention Name(s)
Digital CBT
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Metformin treatment
Intervention Description
Traditional metformin monotherapy.
Primary Outcome Measure Information:
Title
Homeostasis model assessment of insulin resistance
Description
insulin resistance index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Anthropometry
Description
body mass index (kg/m2)
Time Frame
3 months
Title
menstrual frequency
Description
number of menstruation in a year
Time Frame
3 months
Title
fasting glucose
Description
fasting glucose（mmol/L)
Time Frame
3 months
Title
fasting insulin
Description
fasting insulin（mmol/L)
Time Frame
3 months
Title
Total cholesterol
Description
Total cholesterol (mmol/L)
Time Frame
3 months
Title
Triglycerides
Description
Triglycerides (mmol/L)
Time Frame
3 months
Title
HDL-c
Description
HDL-c (mmol/L)
Time Frame
3 months
Title
LDL-c
Description
LDL-c (mmol/L)
Time Frame
3 months
Title
total testosterone
Description
total testosterone (nmol/L)
Time Frame
3 months
Title
free testosterone
Description
free testosterone (nmol/L)
Time Frame
3 months
Title
Sex hormone-binding globulin
Description
Sex hormone-binding globulin (nmol/L)
Time Frame
3 months
Title
Androstenedione
Description
Androstenedione (ng/ml)
Time Frame
3 months
Title
Dehydroepiandrosterone
Description
Dehydroepiandrosterone (ug/dl)
Time Frame
3 months
Title
Food Frequency Questionnaire (FFQ)
Description
Assess diet situation in women with PCOS.
Time Frame
3 months
Title
International Physical Activity Questionnaire (IPAQ)
Description
Assess physical activity situation in women with PCOS.
Time Frame
3 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Assess sleep situation in women with PCOS.
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
To evaluate anxiety and depression in PCOS women.
Time Frame
3 months
Title
Three-Factor Eating Questionnaire (TFEQ-R21)
Description
Assess eating behavior in women with PCOS.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, Doctor
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200070
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating PCOS With Digital CBT vs. Metformin

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