DOZE Sleep App for Youth With Sleep Disturbance

May 21, 2019 updated by: Colleen Carney, Ryerson University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B2K3
        • Ryerson University
        • Contact:
        • Contact:
          • Olya Bogouslavsky, MPH
          • Phone Number: 2185 416-979-5000
          • Email: olya@ryerson.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 15 and 24 years
  • Experiencing sleep disturbance

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Google Analytics: time spent on each app page
Time Frame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
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
Time Frame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
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
Time Frame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
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
Time Frame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
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
Time Frame: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
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)
Time Frame: Baseline (week 0) and endpoint (week 4 or later)
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
Time Frame: Baseline (week 0) and endpoint (week 4 or later)
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
Time Frame: Baseline (week 0) and endpoint (week 4 or later)
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
Time Frame: Baseline (week 0) and endpoint (week 4 or later)
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)
Time Frame: Baseline (week 0) and endpoint (week 4 or later)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Investigators

  • Principal Investigator: Colleen E Carney, PhD, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

May 5, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 348431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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