Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000141347
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
25/01/2017
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results information initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Project Z: A pilot trial of a mobile-phone application to improve sleep in adolescents
Scientific title
Project Z: A pilot trial of the Sleep Ninja - a mobile-phone application to improve sleep in adolescents
Secondary ID [1] 290973 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 301722 0
Sleep disturbance 301723 0
Depression 301724 0
Anxiety 301725 0
Condition category
Condition code
Mental Health 301419 301419 0 0
Depression
Mental Health 301420 301420 0 0
Anxiety
Mental Health 301421 301421 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a mobile-phone application called "Sleep Ninja" which is based on Cognitive Behavioural Therapy (CBT) for Insomnia, and has been designed to help young people with sleep disturbances. The intervention has been gamified such that user completes six training sessions, which teach them strategies to assist with healthy sleep patterns. The material that is covered includes: psychoeducation, stimulus control, emphasis on regularity in sleep-wake cycles, sleep hygiene, behavioural activation to encourage night-time sleepiness and sleep-focused cognitive therapy. Each training session goes for 5-10 minutes and needs to be completed once in every 3-7 days in order for the user to progress to more challenging levels. This core learning component is supplemented by homework exercise that involve tracking sleep via use of an electronic sleep diary. The app also sends reminders to the user about when they should commence their wind-down routine before bed, provides a weekly update on their progress, includes a wide range of helpful sleep tips as well as a bedtime meditation recording. Sleep Ninja is fully-automated and is used independently by young people for 3-6 weeks.
Intervention code [1] 296925 0
Prevention
Intervention code [2] 296962 0
Treatment: Devices
Comparator / control treatment
There is no control group (this is an uncontrolled pilot trial).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300810 0
Insomnia, measured by mean score on the Insomnia Severity Index
Timepoint [1] 300810 0
Change in score between baseline and following the 6-week intervention
Primary outcome [2] 300811 0
Sleep Quality, measured by mean score on the Pittsburgh Sleep Quality Index
Timepoint [2] 300811 0
Change in score between baseline and following the 6-week intervention
Secondary outcome [1] 330937 0
Depression, as measured by the Patient Health Questionnaire-8 (Adolescent Version)
Timepoint [1] 330937 0
Change in score between baseline and following the 6-week intervention
Secondary outcome [2] 330938 0
Anxiety, as measured on Generalised Anxiety Disorder Scale-7
Timepoint [2] 330938 0
Change in score between baseline and following the 6-week intervention
Secondary outcome [3] 331042 0
Total sleep time in minutes, as measured on a self-report sleep diary
Timepoint [3] 331042 0
Change in total sleep time in minutes between baseline and following the 6-week intervention
Secondary outcome [4] 331043 0
Sleep onset latency in minutes, as measured on a self-report sleep diary
Timepoint [4] 331043 0
Change in sleep onset latency in minutes between baseline and following the 6-week intervention
Secondary outcome [5] 331046 0
Sleep efficiency, reported as a percentage based on total sleep time divided by total time in bed, as measured by a self-report sleep diary
Timepoint [5] 331046 0
Change in sleep efficency percentange between baseline and following the 6-week intervention
Secondary outcome [6] 331048 0
Wake after sleep onset, in minutes, as measured on a self-report sleep diary
Timepoint [6] 331048 0
Change in wake after sleep onset in minutes between baseline and following the 6-week intervention

Eligibility
Key inclusion criteria
Young people who have mild-moderate sleep difficulties and own a smartphone. Consent must be provided by both young people and a parent or guardian.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not own a smartphone
Do not have access to the internet and a valid email address
Do not live in Australia
Have no difficulty with their sleep

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2017
Actual
13/04/2017
Date of last participant enrolment
Anticipated
Actual
7/07/2017
Date of last data collection
Anticipated
30/10/2017
Actual
30/10/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295387 0
Charities/Societies/Foundations
Name [1] 295387 0
Corella Fund
Country [1] 295387 0
Australia
Primary sponsor type
Individual
Name
Professor Helen Christensen
Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 294209 0
None
Name [1] 294209 0
Address [1] 294209 0
Country [1] 294209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296722 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 296722 0
University of New South Wales,
Sydney, NSW, 2052
Ethics committee country [1] 296722 0
Australia
Date submitted for ethics approval [1] 296722 0
30/08/2016
Approval date [1] 296722 0
27/09/2016
Ethics approval number [1] 296722 0
HC16702

Summary
Brief summary
The aim of this project is to evaluate a recently developed mobile phone application (app) designed to reduce adolescent sleep problems, which are a common precursor to the onset of mental health problems. This project will investigate whether the sleep app is a feasible and acceptable tool to improve adolescent sleep, and whether there are any secondary effects on depression and anxiety.

The app was developed by the research team, in collaboration with young people, who were consulted in a series of focus groups. We have used the information provided by adolescents to inform the concept and features of the app, which delivers evidence-based psychological strategies to address sleep problems, based on Cognitive Behavioural Therapy for Insomnia. The purpose of this project is to evaluate whether the app, Sleep Ninja, effectively reduces sleep problems experienced by young people with possible capacity to prevent common mental health problems such as depression and anxiety.
Trial website
https://blackdoginstitute.org.au/research/digital-dog/programs/project-z
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71886 0
Dr Aliza Werner-Seidler
Address 71886 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 71886 0
Australia
Phone 71886 0
+61293823769
Fax 71886 0
Email 71886 0
[email protected]
Contact person for public queries
Name 71887 0
Lara Johnston
Address 71887 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 71887 0
Australia
Phone 71887 0
+61293823718
Fax 71887 0
Email 71887 0
[email protected]
Contact person for scientific queries
Name 71888 0
Aliza Werner-Seidler
Address 71888 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 71888 0
Australia
Phone 71888 0
+61293823769
Fax 71888 0
Email 71888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data is presented in aggregate format, no individual level data is available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes http://bmjopen.bmj.com/cgi/content/full/bmjopen-20... [More Details] 372207-(Uploaded-31-05-2019-13-15-21)-Journal results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
439Study results articleYes http://bmjopen.bmj.com/cgi/content/full/bmjopen-20... [More Details] 372207-(Uploaded-31-05-2019-13-15-21)-Journal results publication.pdf
3022Plain language summaryNo Results from this study indicated that the Sleep N... [More Details]

Documents added automatically
No additional documents have been identified.