Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT06672432
Brief Summary:
The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:
1. Does CareMom lower depression scores after an 8-week intervention?
2. Does CareMom lower depression scores at 6 weeks after childbirth?
3. How satisfied are participants with CareMom?
4. What unfavorable events, if any, are associated with the use of CareMom?
Researchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.
Participants will:
1. Engage in the CareMom program or a relaxation training program every day for 8 weeks
2. Complete a series of online questionnaire tests before and after the 8-week intervention.
3. Report any discomfort experienced throughout the study period.
Detailed Description:
A two-arm parallel randomised controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 20-24 weeks of gestation, and randomly allocated to either the intervention group (participate in a mobile app-based 8-week cognitive behavioral therapy program, named CareMom) or the control group (participate in a mobile app-based, attention-matched, 8-week relaxation training program) using a computer-generated random number. The primary outcomes are the changes in Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) scores from From enrollment to the end of intervention at 8 weeks.
Study:
NCT06672432
Study Brief:
Protocol Section:
NCT06672432