Clinical trial NCT03960294: DOZE Sleep App for Youth With Sleep Disturbance
Official title: Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Adolescents
Young Adults
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 145
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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:

1. That participants (AYAs) will find the app satisfactory and credible;
2. DOZE will effect sleep-related behaviour change;
3. 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.


Eligibility criteria: Inclusion Criteria:

* Age between 15 and 24 years
* Experiencing sleep disturbance

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment Evaluation Questionnaire
timeFrame: Endpoint (week 4 or later)
measure: Acceptability E-Scale
timeFrame: Endpoint (week 4 or later)
measure: Qualitative Assessment: Post-Test
timeFrame: Endpoint (week 4 or later)
Secondary outcomes:
measure: Google Analytics: time spent on each app page
timeFrame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
measure: Google Analytics: number of times app logged in
timeFrame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
measure: Google Analytics: number of times app used
timeFrame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
measure: Google Analytics: number of quizzes completed
timeFrame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
measure: Sleep diary parameters
timeFrame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
measure: Center for Epidemiological Studies Depression Scale-Revised (9 items)
timeFrame: Baseline (week 0) and endpoint (week 4 or later)
measure: State-Trait Inventory of Cognitive and Somatic Anxiety
timeFrame: Baseline (week 0) and endpoint (week 4 or later)
measure: Fatigue Severity Scale
timeFrame: Baseline (week 0) and endpoint (week 4 or later)
measure: Cleveland Adolescent Sleepiness Scale
timeFrame: Baseline (week 0) and endpoint (week 4 or later)
measure: Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
timeFrame: Baseline (week 0) and endpoint (week 4 or later)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Colleen E Carney, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Carmona NE, Usyatynsky A, Kutana S, Corkum P, Henderson J, McShane K, Shapiro C, Sidani S, Stinson J, Carney CE. A Transdiagnostic Self-management Web-Based App for Sleep Disturbance in Adolescents and Young Adults: Feasibility and Acceptability Study. JMIR Form Res. 2021 Nov 1;5(11):e25392. doi: 10.2196/25392.