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:
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 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 |
| 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.
|
| Ages Eligible for Study: | 15 Years to 24 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Olya Bogouslavsky, MPH | 4169795000 ext 2185 | olya@arts.ryerson.ca | |
| Contact: Nicole E Carmona, BSc | 4169795000 ext 2185 | nicole.carmona@psych.ryerson.ca |
| 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 | |
| Principal Investigator: | Colleen E Carney, PhD | Ryerson University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 5, 2019 | ||||
| First Posted Date ICMJE | May 23, 2019 | ||||
| Last Update Posted Date | May 23, 2019 | ||||
| Estimated Study Start Date ICMJE | June 2019 | ||||
| Estimated Primary Completion Date | February 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DOZE Sleep App for Youth With Sleep Disturbance | ||||
| Official Title ICMJE | Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II | ||||
| 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:
Exploratory analyses will also be conducted to evaluate which aspects of DOZE participants (AYAs) found most helpful. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Insomnia | ||||
| Intervention ICMJE | Other: DOZE Sleep App
DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.
|
||||
| Study Arms ICMJE | Experimental: DOZE Users
Adolescents and young adults (AYAs) using DOZE for sleep disturbance.
Intervention: Other: DOZE Sleep App
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
145 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 2020 | ||||
| Estimated Primary Completion Date | February 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 15 Years to 24 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03960294 | ||||
| Other Study ID Numbers ICMJE | 348431 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Colleen Carney, Ryerson University | ||||
| Study Sponsor ICMJE | Ryerson University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Ryerson University | ||||
| Verification Date | May 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||