Preventing Perinatal Depression with an App-Based CBT Program

Not Applicable

Not yet recruiting

• Conditions: Perinatal Depression; Disease Prevention

• Registration Number: NCT06672432
• Lead Sponsor: Jintang County Maternal and Child Health Hospital

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?

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study Start: 2024-11
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Changes in depression score at post-intervention	From enrollment to the end of intervention at 8 weeks	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 post-intervention	From enrollment to the end of intervention at 8 weeks	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.
Comparisons of satisfaction level	From enrollment to the end of intervention at 8 weeks	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.
Comparisons of adverse events	From enrollment to the end of intervention at 8 weeks	Comparisons of adverse events between the two groups

Trial Locations

Locations (1)

Jintang County Maternity and Child Health Hospital; 🇨🇳 Chengdu, Sichuan, China