Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-04-20
2025-12-31
Brief Summary
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Detailed Description
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Transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like Cognitive behavioral therapy for insomnia (CBTi) in adults with sleep disorders. However, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain.
Primary aim: Assess the feasibility of implementing the DOZE app.
Secondary aim:
1. To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
2. To determine the required sample size for a future definitive trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
We propose a cohort of the YAC patients to be studied, pre \& post-intervention, prospectively.
All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules).
Optional Actigraphy device use for measuring physical activity, sedentary behavior, sleep health parameters.
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention arm
A cohort of YAC patients to be studied, pre \& post-intervention, prospectively. All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules).
DOZE app
Complete DOZE app: Delivering Online "ZZZ's with Empirical support (DOZE) app plus a Consensus Sleep Diary (CSD).
The DOZE app, is a web-based app optimized for desktop, smartphone, or tablet use. It is a self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected applications that will allow tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log onto the sleep dairy (via automated alerts) once a day over a 10-week period to complete sleep diary entries, develop and track their goals, and receive sleep health education/tailored sleep health interventions.
1-week pre- and post- intervention, participants will complete a battery of baseline study questionnaires and have the option of using a Geneactiv actigraphy device along with a CSD.
Interventions
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DOZE app
Complete DOZE app: Delivering Online "ZZZ's with Empirical support (DOZE) app plus a Consensus Sleep Diary (CSD).
The DOZE app, is a web-based app optimized for desktop, smartphone, or tablet use. It is a self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected applications that will allow tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log onto the sleep dairy (via automated alerts) once a day over a 10-week period to complete sleep diary entries, develop and track their goals, and receive sleep health education/tailored sleep health interventions.
1-week pre- and post- intervention, participants will complete a battery of baseline study questionnaires and have the option of using a Geneactiv actigraphy device along with a CSD.
Eligibility Criteria
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Inclusion Criteria
* Non-malignant chronic pain lasting more than 3 months, with
* Clinically assessed as having a sleep disorder
* English speaking with
* Access to a mobile phone or a computer with internet access.
Exclusion Criteria
* Patients who have received CBT in the past 3 months
* Patients participating in other psychological treatments and/or drug trials during the study
* Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
* Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
* Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work \> 2 nights per week in the past 3months
* Pregnancy or breastfeeding.
* Inability to communicate with health care providers or the research personnel
* Inability to fill out self-report questionnaires, study materials, or follow instructions.
18 Years
25 Years
ALL
No
Sponsors
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Toronto Metropolitan University
OTHER
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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Mandeep Singh, M.D
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Women's College Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-0075-B
Identifier Type: -
Identifier Source: org_study_id
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