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An RCT was not valid anymore as app has become open source and will risk a contamination of study population
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| Name | Class |
|---|---|
| Toronto Metropolitan University | OTHER |
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The aim of the Young Adult Cognitive Behavioral Therapy (YAC) study is to evaluate the effectiveness of the Delivering Online "ZZZ's with Empirical support (DOZE) app, a unique digital cognitive behavioral therapy for insomnia (CBTi) in young adult patients with chronic pain.
Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).
Cognitive behavioral therapy for insomnia (CBTi) is a behavioral modification approach and is currently a frontline therapy for adults with sleep disorders. However, CBTi is still in early stages of development for adolescent and young adult populations, and less so for youth with comorbid 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delivering Online "ZZZ's with Empirical support (DOZE) app | Experimental | The mobile Cognitive Behavioral Therapy for insomnia (CBTi) will be offered using the Delivering Online "ZZZ's with Empirical support (DOZE) app. Patients assigned to the intervention group will be given the DOZE app which is an integrated smart phone app and web based self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected application. Participants will be encouraged to log onto the sleep dairy once a day over 10-weeks to complete sleep diary, develop and track their goals, and receive sleep health education tailored sleep health interventions. After 10-weeks, participants will complete questionnaires on sleep health, pain, and Health Related Quality of Life (HQRL). The use of actigraphy will be optional in view of the COVID19 pandemic. |
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| Sleep Diary Only Attention Control | Active Comparator | The control group will receive the control version of the DOZE app where the patients will be able to access the sleep diary only, without the CBTi intervention. Participants will simply use the app to input entries into their sleep diary as an attention control over a 10-week period. After the 10-week intervention period, participants will again complete a battery of questionnaires on sleep health, pain, and HRQL. The use of actigraphy will be optional in view of the COVID19 pandemic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivering Online "ZZZ's with Empirical support (DOZE) app | Other | The DOZE app is a unique digital CBTi intervention that can be used on any mobile phone, tablet or computer, using the iPhone Operating System (iOS) or Android software. It is an innovative program that consists of an integrated smart phone app and web self-management system ("DOZE") to help adolescents and young adults to sleep better. It allows data capture through entries in a sleep diary and calculation of specific clinical indices. The acquisition of baseline sleep health data over a two-week period is then used to provide personalized targets and tailored therapeutic interventions during the treatment phase. The app also includes a self-monitoring tool that fosters goal setting and provides feedback on sleep and goal attainment. DOZE allows for real time assessment of sleep related behaviors and customized reports and graphs from the young adults' data. The app provides reminders about specific goals and positive feedback (increasing scores) for each step towards a goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Study recruitment/retention | Number of Participants recruited/dropping out of study (accrual/dropout rates) | 1 year |
| Study compliance to DOZE app intervention/Sleep diary | Number of Participants completing/using the DOZE app and completing the sleep diary during 10 weeks study intervention | 10 weeks |
| Study DOZE app treatment evaluation | Participants' scoring on a 5 point Likert scale pre and post study intervention | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported improvement in sleep & pain | Number of Participants reporting Pain Inventory & Sleep Health improvement on a scale of 0 to 10 | 12 weeks |
| Patient reported improvement in Health Related Quality Of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mandeep Singh, MD | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Prospective pilot study with participants randomized to either the intervention Delivering Online "ZZZ's with Empirical support- DOZE app with Sleep diary/Cognitive Behavioral Therapy for insomnia- CBTi) or attention control DOZE app with Sleep diary only groups. Participants will input entries into their sleep diary as an attention control over a 10-week period. For the intervention arm, mobile CBTi will be offered using the DOZE app, an integrated smart phone app and web based self-management program. The intervention will be delivered on restricted password-protected applications that will allow adherence to be tracked. Participants will log onto the sleep dairy once a day over 10-weeks to complete sleep diary entries, develop and track their goals, and receive sleep health education tailored sleep health interventions. After 10-weeks, participants will complete questionnaires on sleep health, pain, and Health Related Quality of Life.
Actigraphy use will be optional
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Following consent, participants will be randomized and allocated to either the intervention or control arm of the trial. Randomization will be centrally controlled, and allocation will be concealed using a secure, web-based randomization on the Research Electronic Data Capture (REDCap) platform. The patients, the clinical care team (pain physicians, sleep physician, occupational therapist, and social worker), outcome adjudicators and the study statisticians will all remain blinded to randomization and group allocation. The personnel teaching the app to the intervention group will be aware of group allocation
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| Sleep diary | Other | The control group will receive the control version of the DOZE app where the patients will be able to access the sleep diary only, without the CBTi intervention. Participants will simply use the app to input entries into their sleep diary as an attention control over a 10-week period. |
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Number of Participants reporting an improvement in HRQOL in Questionnaire
| 12 weeks |
| Patient reported Global Impression of Change | Number of Participants reporting an improvement in PGIC in Questionnaire | 12 weeks |
| D001523 |
| Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |