DOZE Sleep App for Youth With Sleep Disturbance

• ClinicalTrials.gov Identifier: NCT03960294
• Recruitment Status: Unknown
• First Posted: May 23, 2019
• Last Update Posted: May 23, 2019
• Sponsor: Ryerson University
• Information provided by (Responsible Party): Colleen Carney, Ryerson University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Insomnia	Other: DOZE Sleep App	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 145 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II
• Estimated Study Start Date: June 2019
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: March 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age between 15 and 24 years
• Experiencing sleep disturbance

Exclusion Criteria:

• None

Contacts and Locations

Contacts

Contact: Olya Bogouslavsky, MPH; 4169795000 ext 2185; olya@arts.ryerson.ca

Contact: Nicole E Carmona, BSc; 4169795000 ext 2185; nicole.carmona@psych.ryerson.ca

Locations

Canada, Ontario

Ryerson University

Toronto, Ontario, Canada, M5B2K3

Contact: Colleen Carney, PhD 416-979-5000 ext 2177 ccarney@ryerson.ca

Contact: Olya Bogouslavsky, MPH 416-979-5000 ext 2185 olya@ryerson.ca

Sponsors and Collaborators

Ryerson University

Investigators

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

More Information

Publications:

Gradisar M, Gardner G, Dohnt H. Recent worldwide sleep patterns and problems during adolescence: a review and meta-analysis of age, region, and sleep. Sleep Med. 2011 Feb;12(2):110-8. doi: 10.1016/j.sleep.2010.11.008. Epub 2011 Jan 22. Review.

Sivertsen B, Harvey AG, Lundervold AJ, Hysing M. Sleep problems and depression in adolescence: results from a large population-based study of Norwegian adolescents aged 16-18 years. Eur Child Adolesc Psychiatry. 2014 Aug;23(8):681-9. doi: 10.1007/s00787-013-0502-y. Epub 2013 Nov 30.

Hicks RA, Fernandez C, Pellegrini RJ. Striking changes in the sleep satisfaction of university students over the last two decades. Percept Mot Skills. 2001 Dec;93(3):660.

Yang CM, Wu CH, Hsieh MH, Liu MH, Lu FH. Coping with sleep disturbances among young adults: a survey of first-year college students in Taiwan. Behav Med. 2003 Fall;29(3):133-8.

Crowley SJ, Acebo C, Carskadon MA. Sleep, circadian rhythms, and delayed phase in adolescence. Sleep Med. 2007 Sep;8(6):602-12. Epub 2007 Mar 26. Review.

Aoki H, Ozeki Y, Yamada N. Hypersensitivity of melatonin suppression in response to light in patients with delayed sleep phase syndrome. Chronobiol Int. 2001 Mar;18(2):263-71.

Mindell JA, Kuhn B, Lewin DS, Meltzer LJ, Sadeh A; American Academy of Sleep Medicine. Behavioral treatment of bedtime problems and night wakings in infants and young children. Sleep. 2006 Oct;29(10):1263-76. Review. Erratum in: Sleep. 2006 Nov 1;29(11):1380.

Owens JA, Rosen CL, Mindell JA. Medication use in the treatment of pediatric insomnia: results of a survey of community-based pediatricians. Pediatrics. 2003 May;111(5 Pt 1):e628-35.

Stojanovski SD, Rasu RS, Balkrishnan R, Nahata MC. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep. 2007 Aug;30(8):1013-7.

Boerner KE, Coulombe JA, Corkum P. Barriers and facilitators of evidence-based practice in pediatric behavioral sleep care: qualitative analysis of the perspectives of health professionals. Behav Sleep Med. 2015;13(1):36-51. doi: 10.1080/15402002.2013.838766. Epub 2013 Dec 23.

Clarke G, Harvey AG. The complex role of sleep in adolescent depression. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):385-400. doi: 10.1016/j.chc.2012.01.006. Review.

Speth TA, Coulombe JA, Markovich AN, Chambers CT, Godbout R, Gruber R, Hall WA, Reid GJ, Stremler R, Weiss SK, Witmans M, Corkum PV. Barriers, facilitators, and usability of an Internet intervention for children aged 1 to 10 years with insomnia. Translational Issues in Psychological Science 1(1): 16-31, 2015.

Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Colleen Carney, Associate Professor, Ryerson University
• ClinicalTrials.gov Identifier: NCT03960294
• Other Study ID Numbers: 348431
• First Posted: May 23, 2019
• Last Update Posted: May 23, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Colleen Carney, Ryerson University:

Insomnia; Adolescents; Young Adults

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders