Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II
试验速览
- 阶段
- 不适用
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Treatment Evaluation Questionnaire
研究概览
简要总结
Insomnia is a highly prevalent problem among adolescents and young adults (AYAs) with mental health issues. Although evidence-based treatments to quickly address insomnia exist, access to such treatments is limited and there is very little research in AYAs. Furthermore, some of the sleep problems of AYA are unique (e.g., voluntary sleep restriction, circadian phase delay, very poor sleep hygiene), so pediatric and adult programs are not suitable for this age group. This study will test an innovative program that consists of an integrated smart phone application (app) and web self-management system ("DOZE") to help adolescents and young adults sleep better. The first phase of this project, now completed, involved interviewing primary stakeholders of the app (AYAs) to evaluate a low-fidelity prototype of the app and to gather information regarding their opinion about what tools participants would use to improve their health and/or sleep. Using the data from phase I, the investigators have created an app that is acceptable, useful and easy to use while meeting the needs of AYAs experiencing sleep problems. In this study, the investigators will conduct an open trial of the app with 145 AYAs to evaluate usability, acceptability, and sleep and corollary outcomes using a mixed methods design.
The investigators hypothesize:
- That participants (AYAs) will find the app satisfactory and credible;
- DOZE will effect sleep-related behaviour change;
- DOZE will contribute to improvements in energy, mood, and perceived quality of life.
Exploratory analyses will also be conducted to evaluate which aspects of DOZE participants (AYAs) found most helpful.
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
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 and 24 years
- •Experiencing sleep disturbance
排除标准
- 未提供
研究组 & 干预措施
DOZE Users
Adolescents and young adults (AYAs) using DOZE for sleep disturbance.
干预措施: DOZE Sleep App (Other)
结局指标
主要结局
Treatment Evaluation Questionnaire
时间窗: Endpoint (week 4 or later)
A quantitative questionnaire consisting of 5 questions evaluating treatment credibility. Scores range from 5 to 35, with higher scores indicating a more favourable evaluation of treatment.
Acceptability E-Scale
时间窗: Endpoint (week 4 or later)
A quantitative questionnaire, created for the purposes of this study, consisting of 6 questions assessing the acceptability of the app (helpfulness, usefulness, understandability, ease of use, enjoyment, and overall satisfaction) using a 5-point Likert scale. Scores range from 5 to 30, with higher scores indicating greater acceptability of the app.
Qualitative Assessment: Post-Test
时间窗: Endpoint (week 4 or later)
A qualitative questionnaire, created for the purposes of this study, consisting of 4 open-ended questions to obtain feedback on the app. Because of its qualitative nature, no scores are associated with this outcome; rather, this assessment will be used to receive open-ended feedback from the participants about the aspects of the app that they did and did not like.
次要结局
- Google Analytics: number of times app logged in(Everyday for duration of study participation (i.e., week 0 to week 4 or later))
- Google Analytics: time spent on each app page(Everyday for duration of study participation (i.e., week 0 to week 4 or later))
- Sleep diary parameters(Everyday for duration of study participation (i.e., week 0 to week 4 or later))
- Google Analytics: number of quizzes completed(Everyday for duration of study participation (i.e., week 0 to week 4 or later))
- Google Analytics: number of times app used(Everyday for duration of study participation (i.e., week 0 to week 4 or later))
- Center for Epidemiological Studies Depression Scale-Revised (9 items)(Baseline (week 0) and endpoint (week 4 or later))
- Cleveland Adolescent Sleepiness Scale(Baseline (week 0) and endpoint (week 4 or later))
- Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)(Baseline (week 0) and endpoint (week 4 or later))
- State-Trait Inventory of Cognitive and Somatic Anxiety(Baseline (week 0) and endpoint (week 4 or later))
- Fatigue Severity Scale(Baseline (week 0) and endpoint (week 4 or later))
研究者
Colleen Carney
Associate Professor
Toronto Metropolitan University