NCT06672432

Preventing Perinatal Depression with an App-Based CBT Program

Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Jintang County Maternal and Child Health Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perinatal Depression
• Disease Prevention

Interventions

Type	Name	Description
OTHER	CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)	The intervention is divided into daily tasks spread across eight weeks, with each day involving a variety of interactive elements such as videos, text-based content, guided reflections, and mental health check-ins. If the user misses a daily challenge, she can complete that challenge in the later days. Each week has a distinct focus that progressively builds the user's skills and understanding in managing emotional health. Tasks are designed to be short yet impactful, aiming to enhance engagement and adherence.
OTHER	Matched Attention Control (a mobile app-based 8-week online relaxation training program)	This program is designed to mirror the structure and engagement level of the intervention group, providing participants with a similar amount of interaction and daily activities. Each day, participants in the control group will complete 1-2 daily tasks focused on relaxation techniques, such as breathing exercises, mindfulness meditation, and guided imagery. Each task is brief, approximately 3 minutes in duration, making it easy for participants to incorporate into their daily routine.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-07-01
• Completion: 2025-11-01
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: China