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临床试验/NCT04463914
NCT04463914已完成不适用

Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 649 人开始时间: 2021年10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
649
试验地点
2
主要终点
Mean Score of Depressive Symptoms

研究概览

简要总结

The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.

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

  • Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9)57
  • Currently own an iOS- or Android-compatible smartphone
  • Report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
  • Have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
  • Enrolled in Epic's MyChart program
  • English fluency

排除标准

  • Current suicidal ideation at study screening, defined as a response >1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")

结局指标

主要结局

Mean Score of Depressive Symptoms

时间窗: Between baseline and week 12

Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.

次要结局

未报告次要终点

研究者

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

Jennifer Dahne

Assistant Professor

Medical University of South Carolina

研究点 (2)

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