Preventing Perinatal Depression with an App-Based CBT Program
2 other identifiers
interventional
290
1 country
1
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?
- 5.Engage in the CareMom program or a relaxation training program every day for 8 weeks
- 6.Complete a series of online questionnaire tests before and after the 8-week intervention.
- 7.Report any discomfort experienced throughout the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedNovember 4, 2024
October 1, 2024
8 months
October 31, 2024
October 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in depression score at 6 weeks postpartum
Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.
From enrollment to 6 weeks postpartum
Changes in depression score at 6 weeks postpartum
Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.
From enrollment to 6 weeks postpartum
Changes in anxiety score at 6 weeks postpartum
Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.
From enrollment to 6 weeks postpartum
Secondary Outcomes (5)
Changes in depression score at post-intervention
From enrollment to the end of intervention at 8 weeks
Changes in depression score at post-intervention
From enrollment to the end of intervention at 8 weeks
Changes in anxiety score at post-intervention
From enrollment to the end of intervention at 8 weeks
Comparisons of satisfaction level
From enrollment to the end of intervention at 8 weeks
Comparisons of adverse events
From enrollment to the end of intervention at 8 weeks
Study Arms (2)
CareMom group
EXPERIMENTALThe 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.
Control group
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jintang County Maternity and Child Health Hospital
Chengdu, Sichuan, 610499, China
Related Publications (1)
Tang L, Qing H, Li H, Liu C, Wang H, Sun Y, Tan Q, Wu Y, Xiao Y, Lai J, Wang L, Zhong L, Huang F, Li C. Reducing the risk of perinatal depression using an app-based cognitive behavioral therapy program: protocol of a randomized controlled trial. Front Psychiatry. 2025 Apr 14;16:1544753. doi: 10.3389/fpsyt.2025.1544753. eCollection 2025.
PMID: 40297330DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Biostatisticians will be blinded to the study groups, ensuring that all results are analyzed and interpreted without bias.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 4, 2024
Study Start
November 1, 2024
Primary Completion
July 1, 2025
Study Completion
November 1, 2025
Last Updated
November 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
IPD may not be shared due to privacy concerns and the need to protect sensitive information. However, we are open to sharing IPD upon reasonable request, ensuring that appropriate safeguards are in place to maintain participant confidentiality and comply with relevant regulations.