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临床试验/NCT03110016
NCT03110016已完成不适用

Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression

Kibi International University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Feasibility, as measured by adherence to the smartphone application intervention.

研究概览

简要总结

The study aimed to examine the feasibility, usability, user satisfaction, safety, and preliminary efficacy of a smartphone application intervention for young adults with subthreshold depression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18-24 years
  • •Has a Center for Epidemiologic Studies Depression Scale score of ≥16
  • •Owns a smartphone with the iOS® operating system

排除标准

  • •Lifetime history of major depressive disorder
  • •Lifetime history of bipolar disorder
  • •Currently receiving treatment for a mental health problem from a mental health professional
  • •Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview

研究组 & 干预措施

Smartphone Application

Experimental

SPSRS is a smartphone application system designed to improve self-confidence in individuals with subthreshold depression. The application presents a motion picture that displays words every 5 s for improving self-confidence of the user.

干预措施: Smartphone Application (Device)

结局指标

主要结局

Feasibility, as measured by adherence to the smartphone application intervention.

时间窗: 5 weeks after initiating the intervention

Adherence is calculated as the number of minutes in a week for which the participant uses the SPSRS application divided by the recommended weekly duration (70 min).

次要结局

  • Usability and user satisfaction(5 weeks after initiating the intervention)
  • Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.(baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention)
  • Depressive symptoms(baseline and 5 weeks after initiating the intervention)
  • Inflammatory biomarker(baseline and 5 weeks after initiating the intervention)
  • General self-efficacy(baseline and 5 weeks after initiating the intervention)
  • Social anxiety(baseline and 5 weeks after initiating the intervention)
  • Mental health(baseline and 5 weeks after initiating the intervention)

研究者

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

Kazuki Hirao, PhD, OT

Assistant Professor

Kibi International University

研究点 (1)

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