Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Changes in anxiety score at 6 weeks postpartum
研究概览
简要总结
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:
- Does CareMom lower depression scores after an 8-week intervention?
- Does CareMom lower depression scores at 6 weeks after childbirth?
- How satisfied are participants with CareMom?
- 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:
- Engage in the CareMom program or a relaxation training program every day for 8 weeks
- Complete a series of online questionnaire tests before and after the 8-week intervention.
- Report any discomfort experienced throughout the study period.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Biostatisticians will be blinded to the study groups, ensuring that all results are analyzed and interpreted without bias.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in anxiety score at 6 weeks postpartum
时间窗: 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.
Changes in depression score at 6 weeks postpartum
时间窗: 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.
次要结局
- 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)
- Changes in depression score at post-intervention(From enrollment to the end of intervention at 8 weeks)