Clinical Trials Directory

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UnknownNCT03960294

DOZE Sleep App for Youth With Sleep Disturbance

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
145 (estimated)
Sponsor
Toronto Metropolitan University · Academic / Other
Sex
All
Age
15 Years – 24 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERDOZE Sleep AppDOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.

Timeline

Start date
2019-06-01
Primary completion
2020-02-01
Completion
2020-03-01
First posted
2019-05-23
Last updated
2019-05-23

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03960294. Inclusion in this directory is not an endorsement.