An RCT was not valid anymore as app has become open source and will risk a contamination of study population
YAC
Evaluating the Effectiveness of Cognitive Behavioral Therapy for Insomnia on Patient Centered Outcomes Such as Self Efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population: The Young Adult CBTi (YAC)
Sponsor study identifier
interventional
0
1 country
1
Study Start
August 10, 2021
Actual (reported)Primary Completion
August 10, 2021
Actual (reported)Study Completion
August 10, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2021
Actual (reported)August 10, 2021
Actual (reported)August 10, 2021
Actual (reported)August 10, 2021
Actual (reported)November 30, 2021
Actual (reported)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
Patient reported improvement in sleep & pain
12 weeks
Patient reported improvement in Health Related Quality Of Life
12 weeks
Patient reported Global Impression of Change
12 weeks
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.
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.
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.
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Mandeep Singh, MD
Women's College Hospital
0 participants (actual enrollment reported by the registry).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Submitted
March 8, 2021
First Posted
November 30, 2021
Study Start
August 10, 2021
Actual (reported)Primary Completion
August 10, 2021
Actual (reported)Study Completion
August 10, 2021
Actual (reported)Last Updated
September 20, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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