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临床试验/NCT04914299
NCT04914299撤回不适用

Positive Intelligence - Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

Massachusetts General Hospital0 个研究点目标入组 400 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
400
主要终点
Postpartum Depression Symptoms

研究概览

简要总结

The primary aim of the study is to investigate whether a novel mobile App-based behavioral intervention in pregnant women can: (1) prevent and/or decrease the incidence of perinatal mood disorders (2) decrease the severity and/or duration of perinatal mood disorders in affected participants (3) increase access of pregnant women to behavioral intervention and support tools (4) increase the satisfaction of pregnant women with their prenatal care.

详细描述

Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers. Postpartum depression accounts for 12.5% of psychologically related hospitalizations among women.

In 2019, the United States Preventive Services Task Force (USPSTF) recommended screening pregnant women to identify those at risk for perinatal depression and refer them for counseling. The USPSTF recommendation is based on growing literature indicating that counseling women at risk for perinatal depression reduce the risk of having an episode of major depression by 40%.

Supporting that, multiple studies have shown that cognitive-behavioral intervention and mental health care adjuvant therapy can effectively improve the condition of patients with postpartum depression. Finally, access to care has also been shown to be an important factor in determining the success of any intervention. Women across high and low-risk groups often have barriers to treatment due to stigma, shame, and fear to disclose symptoms to health providers

In this research, the investigators aim to investigate whether a novel mobile App-based behavioral intervention can meaningfully increase access and demonstrate a beneficial effect in preventing anxiety and depression in the postpartum period. Furthermore and adding to the existing literature in post-partum depression, this study aims to investigate the role of "positive intelligence", an integrative positive cognitive behavioral therapy, as a tool in the prevention and treatment of perinatal mood disorders.

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
None

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

  • •Able to read and speak English
  • •Have a low-risk singleton pregnancy with more than 24 weeks of gestation
  • •Have smartphone with internet access
  • •Failure to meet criteria for a diagnosis of MDD in the last two months

排除标准

  • •Physical or mental disorders which would interfere with their ability to participate in the study
  • •High-risk pregnancy
  • •Give birth to a newborn at still-birth or a newborn with congenital anomalies and/or Medical complications that require special care in hospital
  • •Infant has a birth weight lower than 2,500 grams
  • •Infant has a 5-minute Apgar score lower than 7

研究组 & 干预措施

A novel mobile-App based intervention

Experimental

An App-based "positive intelligence" intervention consisting of 6 weeks of weekly videos and support group sessions, and 6 weeks of daily App-guided practices.

干预措施: App-based "positive intelligence" intervention (Behavioral)

A novel mobile-App based intervention

Experimental

An App-based "positive intelligence" intervention consisting of 6 weeks of weekly videos and support group sessions, and 6 weeks of daily App-guided practices.

干预措施: Standard of care (Behavioral)

Standard of Care

Active Comparator

Standard prenatal care and follow up

干预措施: Standard of care (Behavioral)

结局指标

主要结局

Postpartum Depression Symptoms

时间窗: 3rd trimester pregnancy till 6 months postpartum

Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale postpartum. Scale 1-30,with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms.

次要结局

  • Patient Satisfaction(6 weeks postpartum to 6 months postpartum)
  • Generalized Anxiety Symptoms(3rd trimester pregnancy till 6 months postpartum)
  • Completion of App-based intervention program(6 weeks postpartum)
  • Patient depression symptoms and severity(3rd trimester pregnancy till 6 months postpartum)

研究者

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

Shay Erisson

Physician, Obstetrics and Gynecology

Massachusetts General Hospital

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