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临床试验/NCT05525689
NCT05525689已完成不适用

Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression

Northwestern University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Depression

研究概览

简要总结

Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.

详细描述

Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.

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
None

入排标准

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

入选标准

  • English speaking
  • 18 years or older
  • Referred to Northwestern Medicine COMPASS program for mental health care
  • Currently pregnant or within 3 months of delivery
  • Moderate to severe perinatal depression (defined as a PHQ-9 screen greater than or equal to 10)
  • Owns a smartphone, has used smartphone in last 7 days

排除标准

  • Experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index pregnancy)
  • Severe suicidality (as defined by the presence of a plan and intent to act on that plan)
  • Not meeting the inclusion criteria described above

结局指标

主要结局

Depression

时间窗: At 12 weeks

Assessed by Patient Health Questionnaire-9 Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

次要结局

  • Anxiety(At 12 weeks)
  • Satisfaction Index - Mental Health(Week 6, Week 12)

研究者

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

David Mohr

Principal Investigator

Northwestern University

研究点 (2)

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