Ryerson University
Toronto, Ontario, M5B2K3
Colleen Carney, PhD, 416-979-5000 ext. 2177, ccarney@ryerson.ca
Olya Bogouslavsky, MPH, 416-979-5000 ext. 2185, olya@ryerson.ca

Other trials in Canada

About this study

Official title: 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:

That participants (AYAs) will find the app satisfactory and credible;
DOZE will effect sleep-related behaviour change;
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: Insomnia
Being tested: DOZE Sleep App
Keywords: Insomnia, Adolescents, Young Adults
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03960294
Study group	Role	What they receive
DOZE Users	Experimental	Adolescents and young adults (AYAs) using DOZE for sleep disturbance. Receives: Other: DOZE Sleep App

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Endpoint (week 4 or later)

Secondary outcomes (10)

Google Analytics: time spent on each app page
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.
Measured: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Google Analytics: number of times app logged in
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.
Measured: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Google Analytics: number of times app used
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.
Measured: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Google Analytics: number of quizzes completed
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.
Measured: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Sleep diary parameters
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
Measured: Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Center for Epidemiological Studies Depression Scale-Revised (9 items)
Scores range from 0 to 36, with higher scores indicating more severe depressive symptoms.
Measured: Baseline (week 0) and endpoint (week 4 or later)
State-Trait Inventory of Cognitive and Somatic Anxiety
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.
Measured: Baseline (week 0) and endpoint (week 4 or later)
Fatigue Severity Scale
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.
Measured: Baseline (week 0) and endpoint (week 4 or later)
Cleveland Adolescent Sleepiness Scale
Scores range from 0 to 64, with higher scores indicating greater sleepiness.
Measured: Baseline (week 0) and endpoint (week 4 or later)
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
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.
Measured: Baseline (week 0) and endpoint (week 4 or later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2019Mar 2020

First posted23 May 2019
Study startJun 2019 (estimated)
Primary completionFeb 2020 (estimated)
Study completionMar 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 145 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03960294
Sponsor's protocol ID: 348431
Status last verified: May 2019
First submitted: 5 May 2019
Last updated: 23 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 21257344
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.
PubMed 24292341
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. doi: 10.2466/pms.2001.93.3.660.
PubMed 11806582
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.
PubMed 15206832
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.
PubMed 17383934
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.
PubMed 11379666
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.
PubMed 17068979
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.
PubMed 12728122
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.
PubMed 17702271
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.
PubMed 24364693
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.
PubMed 22537732
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.
PubMed 22654196
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.
PubMed 34723820

Want to know more?

Olya Bogouslavsky, MPH

4169795000 ext. 2185

olya@arts.ryerson.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II
ClinicalTrials.gov ID: NCT03960294
Acronym / sponsor ID: 348431
Conditions: Insomnia
Keywords: Insomnia, Adolescents, Young Adults
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 145 participants (estimated)
Lead sponsor: Toronto Metropolitan UniversityUniversity, hospital or other
Study start: Jun 2019 (estimated)
Primary completion: Feb 2020 (estimated)
Study completion: Mar 2020 (estimated)
First posted: 23 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize:

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DOZE Users	Experimental	Other: DOZE Sleep AppAdolescents and young adults (AYAs) using DOZE for sleep disturbance.

Who may qualify

Ages: 15 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Age between 15 and 24 years
Experiencing sleep disturbance

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DOZE Sleep AppDOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.	Other	DOZE Users

Primary outcome

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.
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.
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.

10 secondary outcomes

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: 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: number of times app used
Time frame: 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)
Sleep diary parameters
Time frame: 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)
State-Trait Inventory of Cognitive and Somatic Anxiety
Time frame: Baseline (week 0) and endpoint (week 4 or later)
Fatigue Severity Scale
Time frame: Baseline (week 0) and endpoint (week 4 or later)
Cleveland Adolescent Sleepiness Scale
Time frame: 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)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
Background: PubMed 21257344Gradisar 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.
Background: PubMed 24292341Sivertsen 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.
Background: PubMed 11806582Hicks 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. doi: 10.2466/pms.2001.93.3.660.
Background: PubMed 15206832Yang 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.
Background: PubMed 17383934Crowley 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.
Background: PubMed 11379666Aoki 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.
Background: PubMed 17068979Mindell 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.
Background: PubMed 12728122Owens 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.
Background: PubMed 17702271Stojanovski 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.
Background: PubMed 24364693Boerner 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.
Background: PubMed 22537732Clarke 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.
BackgroundSpeth 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olya Bogouslavsky, MPH contact

4169795000 ext. 2185

olya@arts.ryerson.ca

Nicole E Carmona, BSc contact

4169795000 ext. 2185

nicole.carmona@psych.ryerson.ca

Colleen E Carney, PhD principal investigator

Toronto Metropolitan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DOZE Sleep App in people with Insomnia, run by Toronto Metropolitan University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olya Bogouslavsky, MPH (4169795000 ext. 2185, olya@arts.ryerson.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Evaluation Questionnaire (time frame: Endpoint (week 4 or later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03960294, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.