Preventing Perinatal Depression with an App-Based CBT Program

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Changes in depression score at 6 weeks postpartum — From enrollment to 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.
• Changes in depression score at 6 weeks postpartum — From enrollment to 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.
• Changes in anxiety score at 6 weeks postpartum — From enrollment to 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.

Trial sites (1)

Other trials for the same condition