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临床试验/NCT05555745
NCT05555745已完成不适用

Audio-based Mental Health Intervention Study

Penn State University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2023年2月15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
101
试验地点
2
主要终点
Change in symptoms of depression

研究概览

简要总结

This is a study on an audio-based digital intervention designed to reduce symptoms of depression. Participants who experience at least moderate symptoms of depression will be invited to participate in the study. Participants will be randomly assigned to receive one of two audio-based digital interventions. The experimental intervention based on behavioral activation treatment for depression. The control intervention is based on self-monitoring. Depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization)

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

  • Adult age 18 or older
  • Score in the moderate or higher range on the BDI-FastScreen
  • Moderate or higher depression confirmed by DIAMOND interview
  • Proficient English reading, writing, and speaking ability
  • Able to provide consent
  • Provide informed consent

排除标准

  • Below 18 years of age
  • Score below the moderate range on the BDI-FastScreen
  • DIAMOND interview does not confirm moderate or higher depression
  • Unable to read, write, and speak in English
  • Unable to provide consent
  • Do not provide informed consent

结局指标

主要结局

Change in symptoms of depression

时间窗: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.

Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

次要结局

  • Change in negative affect(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
  • Change in symptoms of depression(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
  • Change in positive affect(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
  • Change in symptoms of depression, anxiety, and stress(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
  • Change in behavioral activation(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)

研究者

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

Michelle G. Newman

Professor

Penn State University

研究点 (2)

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