DOZE Sleep App for Youth With Sleep Disturbance

NCT03960294 | Unknown

• 1 other identifier: 348431
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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. 1.That participants (AYAs) will find the app satisfactory and credible;
2. 2.DOZE will effect sleep-related behaviour change;
3. 3.DOZE will contribute to improvements in energy, mood, and perceived quality of life.

Conditions

Insomnia

Keywords

Insomnia; Adolescents; Young Adults

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Google Analytics: time spent on each app page

  Everyday for duration of study participation (i.e., week 0 to week 4 or later)

• Google Analytics: number of times app logged in

  Everyday for duration of study participation (i.e., week 0 to week 4 or later)

• Google Analytics: number of times app used

  Everyday for duration of study participation (i.e., week 0 to week 4 or later)

• Google Analytics: number of quizzes completed

  Everyday for duration of study participation (i.e., week 0 to week 4 or later)

• Sleep diary parameters

  Everyday for duration of study participation (i.e., week 0 to week 4 or later)

Study Arms (1)

DOZE Users

EXPERIMENTAL

Adolescents and young adults (AYAs) using DOZE for sleep disturbance.

Other: DOZE Sleep App

Interventions

DOZE Sleep App OTHER

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

DOZE Users

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15 and 24 years
• Experiencing sleep disturbance

You may not qualify if:

• None

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B2K3, Canada

Location

Related Publications (14)

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  PMID: 21257344 BACKGROUND

• 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.

  PMID: 24292341 BACKGROUND

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  PMID: 11806582 BACKGROUND

• 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. doi: 10.1080/08964280309596066.

  PMID: 15206832 BACKGROUND

• Crowley SJ, Acebo C, Carskadon MA. Sleep, circadian rhythms, and delayed phase in adolescence. Sleep Med. 2007 Sep;8(6):602-12. doi: 10.1016/j.sleep.2006.12.002. Epub 2007 Mar 26.

  PMID: 17383934 BACKGROUND

• 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. doi: 10.1081/cbi-100103190.

  PMID: 11379666 BACKGROUND

• 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.

  PMID: 17068979 BACKGROUND

• 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. doi: 10.1542/peds.111.5.e628.

  PMID: 12728122 BACKGROUND

• 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. doi: 10.1093/sleep/30.8.1013.

  PMID: 17702271 BACKGROUND

• 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.

  PMID: 24364693 BACKGROUND

• 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.

  PMID: 22537732 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22654196 BACKGROUND

• 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.

  PMID: 34723820 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Colleen E Carney, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olya Bogouslavsky, MPH

CONTACT

4169795000; olya@arts.ryerson.ca

Nicole E Carmona, BSc

CONTACT

4169795000; nicole.carmona@psych.ryerson.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)