DOZE Sleep App for Youth With Sleep Disturbance

Study Overview
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Brief Summary
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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.

Official Title
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Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II

Conditions
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Insomnia

Intervention / Treatment
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* Other: DOZE Sleep App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 15 and 24 years Experiencing sleep disturbance Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DOZE Users<br>Adolescents and young adults (AYAs) using DOZE for sleep disturbance. | Other: DOZE Sleep App<br>* DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Evaluation Questionnaire | 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. | Endpoint (week 4 or later) | 
| Acceptability E-Scale | 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. | Endpoint (week 4 or later) | 
| Qualitative Assessment: Post-Test | 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. | Endpoint (week 4 or later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Google Analytics: time spent on each app page | Google Analytics will be used to track the time spent by each participant on each page/area of the app. This information will be used qualitatively to understand which aspects of the app were found least/most helpful. | Everyday for duration of study participation (i.e., week 0 to week 4 or later) | 
| Google Analytics: number of times app logged in | Google Analytics will be used to track the number of times each participant logged into the app. Greater adherence to app use (and daily sleep tracking) indicates greater acceptability of the app. | Everyday for duration of study participation (i.e., week 0 to week 4 or later) | 
| Google Analytics: number of times app used | Google Analytics will be used to track the number of times participants used the app. Greater app use indicates greater acceptability of the app. Google Analytics will provide a count of the number of times the app was accessed. | Everyday for duration of study participation (i.e., week 0 to week 4 or later) | 
| Google Analytics: number of quizzes completed | Google Analytics will be used to track the number of quizzes each participant completed. Quizzes are included in the app under the Tips heading, and include questions that related to chronotype, difficulty winding down, difficulty getting up, sleep drunkenness, trouble staying awake, and fatigue. Quizzes are an optional feature of the app which are used to provide participants with psychoeducation about these topics and how they relate to symptoms of sleep disturbance. | Everyday for duration of study participation (i.e., week 0 to week 4 or later) | 
| Sleep diary parameters | Data extracted from sleep diaries, including variability in bedtime, variability in rise time, total sleep time, total time in bed, sleep onset latency, wake after sleep onset, number of awakenings, naps | Everyday for duration of study participation (i.e., week 0 to week 4 or later) | 
| Center for Epidemiological Studies Depression Scale-Revised (9 items) | Scores range from 0 to 36, with higher scores indicating more severe depressive symptoms. | Baseline (week 0) and endpoint (week 4 or later) | 
| State-Trait Inventory of Cognitive and Somatic Anxiety | This measure includes two scales: a state scale (with scores ranging from 21 to 84) and a trait scale (with scores ranging from 21 to 84). Higher scores on both scales indicate more severe symptoms of anxiety. | Baseline (week 0) and endpoint (week 4 or later) | 
| Fatigue Severity Scale | A total score is computed by summing all of the items (range: 9 to 63) and dividing the score by the number of items to yield an item average. Average scores range from 1 to 7, with higher average scores indicating more impairment due to fatigue. | Baseline (week 0) and endpoint (week 4 or later) | 
| Cleveland Adolescent Sleepiness Scale | Scores range from 0 to 64, with higher scores indicating greater sleepiness. | Baseline (week 0) and endpoint (week 4 or later) | 
| Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) | Assesses health-related quality of life using 8 subscales: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Items in which higher scores indicate better functioning are reverse scored when creating subscale scores. Subscale scores are converted to T scores ranging from 0 to 100, with higher scores indicating worse functioning. | Baseline (week 0) and endpoint (week 4 or later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Adolescents, Young Adults