About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

290 Participants

are divided into 2 treatment groups

Group A: CareMom groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

From enrollment to 6 weeks postpartum

2

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.

Time frame

From enrollment to 6 weeks postpartum

3

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.

Time frame

From enrollment to 6 weeks postpartum

Secondary outcomes

1

Changes in depression score at post-intervention

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.

Time frame

From enrollment to the end of intervention at 8 weeks

2

Changes in depression score at post-intervention

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.

Time frame

From enrollment to the end of intervention at 8 weeks

3

Changes in anxiety score at post-intervention

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.

Time frame

From enrollment to the end of intervention at 8 weeks

4

Comparisons of satisfaction level

Comparisons of Client Satisfaction Questionnaire (CSQ-8) results between the two groups. CSQ-8 consists of 8 items, resulting in scores that range from 8 to 32, with each item evaluated on a Likert scale; higher scores reflect greater levels of satisfaction.

Time frame

From enrollment to the end of intervention at 8 weeks

Preventing Perinatal Depression with an App-Based CBT Program

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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