Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
研究概览
简要总结
Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged between 16-40 years;
- •having a score of >7 on the Edinburgh Postnatal Depression Scale (EPDS);
- •gestational age between 17-26 weeks;
- •being literate;
- •owning a functional smartphone with Android for personal use.
排除标准
- •pregnancies classified as being at risk, fetal malformation, or congenital disease;
- •visual, auditory or intellectual disabilities, or chronic diseases associated with fetal development alterations;
- •severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).
结局指标
主要结局
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
时间窗: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).
次要结局
- Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Infant Social/Emotional Problems at 2 Months of Age.(When the infant is two months of age (Follow-up, T3).)
- Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).(Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Infant Developmental Milestones at 2 Months of Age.(When the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Depression From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
研究者
Guilherme Vanoni Polanczyk, MD PhD
Professor
University of Sao Paulo