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临床试验/NCT05757453
NCT05757453已完成1 期

BoostOne Study (MHealth)

NXTech2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Interaction Engagement, as Assessed by Interactions Completed

研究概览

简要总结

The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

详细描述

The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone package (mHealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Diagnosis of opioid use disorder
  • Experiencing symptoms multiple times per week
  • Familiar with smartphone usage

排除标准

  • None specified

结局指标

主要结局

Interaction Engagement, as Assessed by Interactions Completed

时间窗: At 8 weeks

Interactions Completed (interactions completed, range 0 to unbound)

次要结局

  • Intervention Usability Rating, as Assessed by Likert User Experience Scale(At 8 weeks)
  • Treatment Progress Measure, as Assessed by TEA Score(At 8 weeks)

研究者

发起方
NXTech
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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