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临床试验/NCT03990389
NCT03990389已完成不适用

Automated Symptom Tracking for Measurement-Based Care of Depression

University of Chicago4 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年2月20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
31
试验地点
4
主要终点
Longitudinal Change in Depression Severity

研究概览

简要总结

The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators have developed a chatbot which will assist in performing measurement-based care (MBC) via Facebook Messenger. Participants will be randomized to either Usual Care or Usual Care with additional Chatbot Care.

详细描述

The goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. The investigators will be looking specifically at depressed women soon after they give birth, otherwise known as known as perinatal depression. Measurement-based care (MBC) which involves the use of quantitative assessments for depression screening, diagnosis, and symptom monitoring is recognized as one of the keys to depression management. MBC can be difficult to implement within the clinical setting due to the administrative overhead and close follow-up required. It is reasonable to hypothesize that low rates of MBC adoption are responsible for low rates of adequate depression care.

The investigators have developed an automated conversational agent or "chatbot" (CB) for delivering MBC via Facebook Messenger. The investigators hypothesize that the use of CB-MBC, which combines a conversational interface with state-of-the-art quantitative assessments, will improve depression symptom severity for patients with perinatal depression. If successful, this project will provide primary care physicians with a new and inexpensive method for delivering better and safer care to their patients with depression. This study works to determine the impact of the chatbot in improving depression outcomes for patients under treatment for perinatal 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
All
接受健康志愿者

入选标准

  • Provider Subject Cohort: residents and attendings from University of Chicago Medical Center OBGYN and NorthShore Hospital OBGYN clinics.
  • Patient Subject Cohort:
  • Age ≥ 18 years and able to and demonstrate English reading literacy of at least 8th-grade level (REALM-R ≥ 6)
  • Postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (EPDS ≥ 12)
  • Willing to participate and able to give written informed consent
  • Must own a smart phone with a data plan
  • Must have a Facebook account and Facebook Messaging app on phone (or willing to create account/download app today)
  • Sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance

排除标准

  • Provider Subject Cohort: None
  • Patient Subject Cohort:
  • Subjects with documented dysthymia or Axis II diagnoses
  • Subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation
  • Active suicidality as determined by clinician
  • Non-English speakers

结局指标

主要结局

Longitudinal Change in Depression Severity

时间窗: 3 months

Measured by the Edinburgh Postnatal Depression Scale (EPDS) Range 0-30 (dimensionless) Risk of depression goes up with an increasing score

次要结局

  • Change in Maternal Confidence(3 months)
  • Medication Adherence(3 months)
  • Change in Depression Severity(3 months)
  • Change in Side-effect Burden(3 months)
  • Change in Maternal Function(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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