Preventing Perinatal Depression with an App-Based CBT Program

Jintang County Maternal and Child Health Hospital

Status: Not yet enrolling

Conditions: Perinatal Depression; Disease Prevention

Treatments: Other: Matched Attention Control (a mobile app-based 8-week online relaxation training program); Other: CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)

Study type: Interventional

Funder types: Other

Identifiers

NCT06672432

2024673 (Other Grant/Funding Number)

20240511-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 18-45 years
• at 20-24 weeks of gestation
• at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12
• own a smartphone
• are able to independently engage with the program

Exclusion criteria

• have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor
• have a prior diagnosis of any mental disorders
• are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments
• have a history of self-harm or suicide
• have any suicidal thoughts in the past 12 months
• experienced fetal deaths in the past 18 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups

CareMom group

Experimental group

Description:

The intervention program, CareMom, is a structured, 8-week digital intervention delivered through a WeChat mini-program in Chinese, developed by Shanghai Thoven Technology Co. Ltd., China, under the guidance of psychologists and psychiatrists. CareMom is designed to support perinatal mental health by providing daily challenges, educational content, and interactive exercises that target cognitive restructuring, behavioral activation, and worry management, key therapeutic components for alleviating symptoms of depression and anxiety. Participants in the intervention group will also receive standard perinatal care throughout the study. This includes routine prenatal check-ups, postpartum nursing care, and scheduled postnatal visits, ensuring that all participants receive the essential healthcare services typically provided during the perinatal period.

Treatment:

Other: CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)

Control group

Active Comparator group

Description:

The control group in this study will participate in an attention-matched, 8-week online relaxation training program delivered through a mobile application. Participants in the control group will also continue to receive standard perinatal care. This standard care is not altered or influenced by participation in the study, ensuring that all participants receive the usual care necessary for perinatal health.

Treatment:

Other: Matched Attention Control (a mobile app-based 8-week online relaxation training program)