Preventing Perinatal Depression with an App-Based CBT Program

Official title

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

Overview

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.

Interventions

• 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 engagemen
• 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.

Primary outcome measures

• Changes in depression score at 6 weeks postpartum [Time frame: From enrollment to 6 weeks postpartum]
• Changes in depression score at 6 weeks postpartum [Time frame: From enrollment to 6 weeks postpartum]
• Changes in anxiety score at 6 weeks postpartum [Time frame: From enrollment to 6 weeks postpartum]

Secondary outcome measures (5)

• Changes in depression score at post-intervention [Time frame: From enrollment to the end of intervention at 8 weeks]
• Changes in depression score at post-intervention [Time frame: From enrollment to the end of intervention at 8 weeks]
• Changes in anxiety score at post-intervention [Time frame: From enrollment to the end of intervention at 8 weeks]
• Comparisons of satisfaction level [Time frame: From enrollment to the end of intervention at 8 weeks]
• Comparisons of adverse events [Time frame: From enrollment to the end of intervention at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Jintang County Maternity and Child Health Hospital — Chengdu

Publications

• 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 40297330

Identifiers

NCT: NCT06672432 · 20240511-1 · 2024673

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗