跳至主要内容
临床试验/NCT04640090
NCT04640090已完成不适用

Effectiveness of a Smartphone Wellness App to Improve Mental Well-being: A Pilot Study

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月12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
60
试验地点
2
主要终点
Mean change in depression symptoms

研究概览

简要总结

This pilot project will evaluate the potential of an affordable smartphone app to improve users' mental well-being.

详细描述

The goal of this pilot study is to evaluate whether a smartphone wellness application has the potential to improve anxiety and depression symptoms in people who otherwise would not have access to behavioral health care. In this pilot study, participants will include patients who present to an orthopedic specialist for chronic musculoskeletal pain and who also endorse elevated anxiety and/or depression symptoms. Patients who otherwise do not have access to adequate behavioral health resources will be eligible to enroll in the study. Through the study, participants will have two months of full access to a commercially available smartphone wellness application which offers resources such as cognitive behavioral therapy via an artificial chatbot, mindfulness and deep breathing training, and text-based access to a human well-being coach. Participants' baseline and 2-month follow-up anxiety and depression symptoms will be compared. Qualitative feedback regarding the user experience with the smartphone application will also be collected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Presentation to an orthopedic specialist at the Washington University Living Well Center for a musculoskeletal condition
  • Score of 55 or higher on Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and/or Anxiety measures
  • Advised to consider behavioral health treatment as a component of comprehensive care for a musculoskeletal condition
  • Cannot or does not wish to pursue in-person behavioral health treatment (e.g., with the center psychologist)

排除标准

  • No access to an electronic device (such as a smartphone) to download and use the wellness app and to electronically complete follow-up self-reported health measures
  • In active mental health crisis (e.g., suicidal/homicidal thoughts, psychosis) which would require an escalated level of care
  • Initiating care with a behavioral health specialist

结局指标

主要结局

Mean change in depression symptoms

时间窗: 2 months

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores

Mean change in anxiety symptoms

时间窗: 2 months

Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores

次要结局

  • Mean change in depression symptoms(1 month)
  • Mean change in pain interference symptoms(1 month and 2 months)
  • Mean change in physical function symptoms(1 month and 2 months)
  • Frequency of app usage(1 month and 2 months)
  • Mean change in anxiety symptoms(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验