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临床试验/NCT05055674
NCT05055674Unknown不适用

Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression

University of Sao Paulo0 个研究点目标入组 264 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
264
主要终点
Depression symptoms

研究概览

简要总结

Investigators will be test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Participants will be randomly allocated to receive the Motherly app (intervention), or COMVC (active control), a smartphone app that delivers only psychoeducational content related to general mental health.

详细描述

The postpartum period is strongly associated with increased risk for depression, with estimates of approximately 19% of women affected by the disorder. Psychosocial interventions such as home visiting programs and well-established psychological therapies are efficient to treat this condition but require a significant number of qualified trained professionals. However, financial and human resources to meet these demands are scarce in developing countries such as Brazil. Therefore, interventions delivered via electronic devices such as smartphones might fill this gap. Our objective is to test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Two-hundred and sixty-four (N=264) 18-40-years-old women with postpartum depression will be to one of two groups: (1) intervention, which will have access to the Motherly app; or (2) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content on general mental health (COMVC means "With You" in Brazilian Portuguese). Duration of treatment will be four weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), end (post treatment, T1), and 1 month after treatment completion (follow-up, T2).

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
Single (Outcomes Assessor)

盲法说明

Participants will be aware of the intervention received, as well as investigators and professionals responsible for monitoring app usage during the study. The Outcome assessor will be blind to randomization status.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who had given birth to a live baby in the past 12 months;
  • Age between 18-40 years;
  • Edinburgh Postnatal Depression Scale (EPDS) total score ≥ 10;
  • Depression symptoms present in the past 2 weeks;
  • Being literate;
  • Owing an Android or iPhone smartphone for personal use.

排除标准

  • Intellectual, visual, or auditory deficiency;
  • Chronic diseases that prevent using smartphones or understanding how to use the apps;
  • Severe and/or chronic mental health diagnosis (schizophrenia or bipolar disorder).

结局指标

主要结局

Depression symptoms

时间窗: Posttreatment (T1) 1 month after baseline

Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1)

次要结局

  • Parental Distress(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Attachment(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Anxiety symptoms(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Sleep quality(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Parenting stress(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Parenting Competence(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Depression symptoms(Follow-up (T2) 2 months after baseline)
  • Quality of Life: Physical Health(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Quality of Life: Mental Health(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Parent-child Dysfunctional Interaction(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
  • Difficult Child(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Vanoni Polanczyk, MD PhD

Associate Professor

University of Sao Paulo

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