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临床试验/NCT05108194
NCT05108194Unknown早期 1 期

Feasibility of a Personalized Short Message Service Intervention for Insomnia

University of Missouri, St. Louis1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月15日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
50
试验地点
1
主要终点
Insomnia Severity Index

研究概览

简要总结

The goal of this research is to establish a proof of concept for optimizing and evaluating a personalized SMS intervention based for individuals with chronic sleep problems.

详细描述

Insomnia is a pervasive disorder affecting approximately 10-40% of the U.S. population in a given year. In addition, insomnia has been identified as a transdiagnostic symptom that cuts across numerous other psychological disorders. Interventions that target disordered sleep may attenuate symptomatic distress for a multitude of psychological disorders, making it a potentially potent intervention target with broad public health potential. Despite the ubiquity of the problem, only a fraction of individuals who could benefit actually receive the most effective intervention for insomnia, cognitive behavioral therapy for insomnia (CBT-I). Emerging research has pointed to the possibility of monitoring behavior and delivering personalized interventions to specific individuals via mobile devices. Personalized and adaptive interventions delivered via Short Message Service (SMS) provide a relatively simple solution to prompt individuals to engage in personalized interventions outside the context of opening or downloading a mobile mental health app. The content of text messages have the capacity to modulate behavior via prompts, motivational messages, and "nudges." By using brief, motivational messages based on evidence-based treatment for sleep (e.g. CBT-I), there is the potential to reduce dysfunctional sleep patterns at scale.

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

盲法说明

All participants will be enrolled in the intervention and all participants and study staff will be aware.

入排标准

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

入选标准

  • •clinical insomnia (defined by scoring ≥ 15 on the insomnia severity index)

排除标准

  • •under 18 y.o.
  • •unable to read or write in English
  • •do not own a Smart Phone

研究组 & 干预措施

Arm 1: Intervention

Experimental

Participants (N=50) who endorse insomnia will be followed for 8 weeks. All participants will be asked to download a separate app to passively monitor sleep that will inform the personalized messages. Participants will also be asked to respond to daily prompts in order to validate the passive sleep data. The study includes two phases: (1) a training and validation phase and (2) an intervention phase. During phase 1, participants' sleep habits and other behaviors will be monitored for two weeks in order to validate and optimize the SMS personalized sleep intervention (PSI). In phase 2, participants will be transitioned to the intervention phase of the study.

干预措施: SMS Personalized Sleep Intervention (Behavioral)

结局指标

主要结局

Insomnia Severity Index

时间窗: 8 weeks

Insomnia severity

次要结局

  • System Usability Scale(8 weeks)

研究者

发起方
University of Missouri, St. Louis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chelsey Wilks

Assistant Professor

University of Missouri, St. Louis

研究点 (1)

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