Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000833460
Ethics application status
Approved
Date submitted
25/06/2025
Date registered
4/08/2025
Date last updated
4/08/2025
Date data sharing statement initially provided
4/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
What happens when a program is released into the wild? Measuring the impact of the Sleep Ninja application
Scientific title
What happens when a program is released into the wild? Measuring the impact of the Sleep Ninja application on insomnia among users of the app from the general Australian public.
Secondary ID [1] 314739 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12617000141347 - Pilot trial of the Sleep Ninja intervention that included N=50 Australian adolescents and was completed in 2017.

ACTRN12619001462178 - Randomised controlled trial of the Sleep Ninja intervention that included N=260 Australian adolescents and was completed in 2021.

Health condition
Health condition(s) or problem(s) studied:
Sleep 337950 0
Depression 337951 0
Condition category
Condition code
Mental Health 334271 334271 0 0
Depression
Mental Health 334359 334359 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sleep Ninja® is a self-guided, smartphone-based intervention based on Cognitive Behavioural Therapy for Insomnia (CBTi) to treat sleep disturbance in young people. https://www.blackdoginstitute.org.au/sleep-ninja/

The Sleep Ninja app takes the form of a chat-bot i.e. when the app is open, users communicate with the Sleep Ninja in the app via a forced choice text messaging platform. The Sleep Ninja, who acts as a sleep coach is programmed to respond to the selection made by the user.

Sleep Ninja includes six training modules based on CBT-I with each module taking approximately 5-10 minutes to complete. The modules include the following skills and strategies: psychoeducation, sleep scheduling, stimulus control, sleep focused cognitive therapy, sleep hygiene and behavioural activation. Modules are unlocked sequentially, with the next module unlocked after completion of the previous module and three nights of sleep tracking within the apps sleep diary. At the completion of each module, users are given feedback about their sleep.

There are additional optional features that users can access at their discretion, which include a meditation recording, extra sleep information, sleep tips and a “Get Help Now” button that links directly to Australian crisis support services.

A randomised controlled trial that included N=264 Australian teenagers (ACTRN12619001462178) demonstrated a reduction in insomnia and depression symptoms for those in the intervention group relative to an attention-matched control group. The app is now available to the Australian public, free of charge, via the Google Play and Apple stores.

This study is a follow-up study to the previously completed RCT (ACTRN12619001462178) that will assess clinical effectiveness and adherence in a real-world setting. Sleep Ninja was made available to the Australian general public in Feb-2023. This real-world study will include data from all app users (i.e. general public users) who downloaded the Sleep Ninja app between Feb-2023 and July-2024.

Sleep Ninja users complete brief self-report measures on sleep, depression, anxiety and quality of life at download, after completion of three (of six) content modules, and on completion of the final (sixth) content module.

These data will be collected via a one-off extraction from the Sleep Ninja data server. Data will also include the number of content modules completed (range 0-6) as a measure of adherence.
Intervention code [1] 331587 0
Not applicable
Comparator / control treatment
This trial will examine the ongoing clinical efficacy of a publically available digital mental health tool (Sleep Ninja). There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341935 0
Sleep
Timepoint [1] 341935 0
Baseline, mid-intervention (after completion of the third of six modules), post-intervention (after completion of the sixth and final module; primary timepoint)
Secondary outcome [1] 449062 0
Depression
Timepoint [1] 449062 0
Baseline, mid-intervention (after completion of the third of six modules), post-intervention (after completion of the sixth and final module)
Secondary outcome [2] 449063 0
Anxiety
Timepoint [2] 449063 0
Baseline, mid-intervention (after completion of the third of six modules), post-intervention (after completion of the sixth and final module)
Secondary outcome [3] 449064 0
Quality of life
Timepoint [3] 449064 0
Baseline, mid-intervention (after completion of the third of six modules), post-intervention (after completion of the sixth and final module)
Secondary outcome [4] 450272 0
Adherence
Timepoint [4] 450272 0
Post-intervention.

Eligibility
Key inclusion criteria
Data from all individuals who used the Sleep Ninja app between Feb-2023 (when the app was released publicly) and Jul-2024 will be included. Note that a waiver of cosnent was sought and received from an Australian Human Research Ethics Committee to access and analyse these daya for the purposes of this study.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil. Data from all individuals who used the Sleep Ninja app between Feb-2023 and Jul-2024 will be included.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
This 'in the wild' trial will include data from 12,195 individuals who used the Sleep Ninja app between Feb-2023 and Jul-2024.. This sample size is consistent with other recent studies that have examined the “real world” impact of digital mental health apps for young people, where samples between 9,000 and 13,000 have been reported (1, 2).

Descriptive and frequency analyses will be used to characterise users of the app. Linear mixed level modelling will be used to examine changes in sleep, depression, anxiety and quality of life among users of the app. Correlations, t-tests, and chi square tests will be used to examine patterns of usage associated with the greatest benefits for sleep, mood, anxiety and quality of life.


1. Lucassen, M.F., Stasiak, K., Fleming, T., Frampton, C., Perry, Y., Sheperd, M., & Merry, S.N. (2021). Computerized cognitive behavioural therapy for gender minority adolescents: Analysis of the real-world implementation of SPARX in New Zealand. Australian & New Zealand Journal of Psychiatry, 55(9):874-882.

2. Prochaska, J.J., Wang, Y., Bowdring, M.A., Chieng, A., Chaudhary, N.P., Ramo, D.E. (2023). Acceptability and utility of a smartphone app to support adolescent mental health: Program evaluation study. JMIR mHealth & uHealth. 11:e47183.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
12195
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319292 0
Other Collaborative groups
Name [1] 319292 0
Black Dog Institute
Country [1] 319292 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321769 0
None
Name [1] 321769 0
Address [1] 321769 0
Country [1] 321769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317871 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317871 0
Ethics committee country [1] 317871 0
Australia
Date submitted for ethics approval [1] 317871 0
11/07/2024
Approval date [1] 317871 0
13/09/2024
Ethics approval number [1] 317871 0
6960

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142414 0
A/Prof Aliza Werner-Seidler
Address 142414 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 142414 0
Australia
Phone 142414 0
+61 412 657 812
Fax 142414 0
Email 142414 0
[email protected]
Contact person for public queries
Name 142415 0
Adam Theobald
Address 142415 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 142415 0
Australia
Phone 142415 0
+61435342923
Fax 142415 0
Email 142415 0
[email protected]
Contact person for scientific queries
Name 142416 0
Aliza Werner-Seidler
Address 142416 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 142416 0
Australia
Phone 142416 0
+61 412 657 812
Fax 142416 0
Email 142416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The conditions of our ethics approval prohibit sharing of individual participant data.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.