Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000777392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/06/2026
Date registered
Help: Date registered
29/06/2026
Date last updated
Help: Date last updated
29/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a smartphone app, Sleep Ninja, on insomnia, sleep and depression in young people experiencing insomnia and depression symptoms
Scientific title
BRAINWAVES: A Randomised Controlled Trial of a Sleep app (Sleep Ninja, Cognitive Behavioural Therapy for Insomnia) on insomnia and depression and anxiety symptoms in young people experiencing insomnia and depression symptoms
Additional trial identifiers [1] 316640 0
23/480
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study is an extension of ACTRN12622001453774 pilot study in healthy young people.
The participants recruited to ACTRN12622001453774 were healthy. The current trial is an RCT of Sleep Ninja (an attention-matched control app) and participants are those experiencing insomnia and depression symptoms

Health condition
Health condition(s) studied:
Mental Health 340846 0
depression 340847 0
anxiety 342415 0
insomnia 342610 0
Condition category
Condition code
Mental Health 337007 337007 0 0
Depression
Mental Health 338427 338427 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Sleep Ninja
Sleep Ninja is a smartphone app that delivers CBT-I in an accessible, relevant way for young people. It was developed by the Black Dog Institute and includes the core CBT-I approaches: psychoeducation, sleep scheduling, stimulus control, sleep-focused cognitive therapy, sleep hygiene and behavioural activation. Users communicate with the Sleep Ninja, a sleep coach, via a forced-choice text messaging platform. The app is based on gaming principles and users progress through six levels of ‘belts’, starting with a white belt and working their way to black belt status. To obtain each belt, users must complete one ‘training session’ (module), which takes about 5 minutes, and log three nights (within 7 days) of sleep tracking within the app’s sleep diary. When they have completed each belt, they receive feedback on their sleep and specific advice if they indicate that their wake-up time varies by more than 2 hours from the previous day or if they log that they had less than 6 hours of sleep. Optional features include access to a meditation recording, extra sleep information, sleep tips, and ‘get help now’ that links directly to New Zealand crisis support services and helplines. If participants agree, the app sends reminder notifications to enter sleep diaries, begin winding down for sleep, complete training sessions, and return after periods of inactivity.
The standard duration of the intervention is 6 weeks (one week per belt level), though because of the 3 sleep logs per level, it can be completed in a minimum of 18 days. The active study period tracks participants over 30 days.


Intervention code [1] 333320 0
Behaviour
Intervention code [2] 334347 0
Prevention
Intervention code [3] 334348 0
Treatment: Other
Description of the comparator or control
My Mood Attention matched control app
My Mood is a daily mood-tracking tool. Users receive a push notification once a day to log their mood on a half-circle (with editable descriptors that allow young people to use their own words, on a 0-10 scale), with an optional journal-style reflection feature. The app is intended for use in research settings as a control app, engaging young people to control for logging in and brief engagement. Engagement with the app is brief (less than 2 minutes per day), sufficient time to log a daily mood score and enter an optional brief text reflection.
To maintain matching attention and engagement controls with the active intervention group, the overall duration of My Mood is the same as for Sleep Nina, over 30 days.
Control group
Active

Outcomes
Primary outcome [1] 344531 0
insomnia severity
Timepoint [1] 344531 0
Baseline (T1), 15 days (T2), 30 days (T3, postintervention), 90 days (T4, follow up) (ISI is at every timepoint)
Primary outcome [2] 345538 0
Depression
Timepoint [2] 345538 0
Baseline (T1), 30 days (T3, postintervention), 90 days (T4, follow up) (at T2 (15 days) just the PHQ 2 and the ISI are administered therefore the full PHQ-8 is administered at T1, T3, and T4)
Secondary outcome [1] 462074 0
Sleep disturbance
Timepoint [1] 462074 0
Baseline (T1), 30 days (T3, postintervention), 90 days (T4, follow up) (PROMIS is not taken at the mid intervention 15 day timepoint, T2)
Secondary outcome [2] 462075 0
Anxiety GAD-7
Timepoint [2] 462075 0
Baseline (T1), 30 days (T3, postintervention), 90 days (T4, follow up) (GAD7 is not taken at the mid intervention 15 day timepoint, T2)
Secondary outcome [3] 462076 0
Wellbeing Hua Oranga
Timepoint [3] 462076 0
Baseline (T1), 30 days (T3, postintervention), 90 days (T4, follow up) (Hua Oranga is not taken at the mid intervention 15 day timepoint, T2)

Eligibility
Key inclusion criteria
Living in Aotearoa New Zealand
Score of over 8 on the Insomnia Severity Index (ISI)
score at least 1 on the 2-item PHQ
Minimum age
16 Years
Maximum age
18 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants with insomnia and depression symptoms

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once participants have registered and completed baseline assessment, the Tirohia Platform will randomly assign a unique number to study participants using a pre-generated randomisation list embedded in the system. Only the independent statistician will have access to this list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to study arms (1:1 ratio) via a pre-generated randomisation list embedded in Tirohia. Using a blind-to-hypothesis approach, participants will not know whether the app they have been allocated is an intervention or the control app but will be informed they will be randomly assigned to one of two apps. This approach means that detection bias can be avoided, as all outcome measures are self-report.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
The trial is powered for the primary outcome: the between-group difference in Insomnia Severity Index (ISI) score at 30 days. We assume a standardised effect of Cohen's d = 0.42, corresponding to a difference of approximately 1.7 ISI points (assuming a between-person SD of 4). This is consistent with the controlled between-group effect on insomnia reported in the only prior randomised trial of Sleep Ninja in adolescents (d = .39–.41 on the ISI; Werner-Seidler et al., 2023), from which the ISI standard deviation was also taken. The primary analysis is a linear mixed model for repeated measures (fixed effects for group, time, and their interaction; random intercept for participant) estimating the day-30 between-group contrast, with alpha = 0.05 (two-sided) and an assumed baseline-to-30-day ISI correlation of 0.50. Allowing for 35% attrition at 30 days, consistent with rates typical of digital mental-health trials [47], a sample of 135 participants per arm (270 total) provides approximately 80% power to detect the primary effect. Power was estimated by simulation in R using the lme4 package.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2026
Actual
Date of last participant enrolment
Anticipated
30/10/2026
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 27861 0
New Zealand
State/province [1] 27861 0

Funding & Sponsors
Funding source category [1] 321254 0
Government body
Name [1] 321254 0
Health Research Council (HRC) of New Zealand
Country [1] 321254 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 323965 0
None
Name [1] 323965 0
Address [1] 323965 0
Country [1] 323965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319782 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 319782 0
Ethics committee country [1] 319782 0
New Zealand
Date submitted for ethics approval [1] 319782 0
21/04/2023
Approval date [1] 319782 0
06/06/2023
Ethics approval number [1] 319782 0
AH25767

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

Contacts
Principal investigator
Name 148382 0
Dr Nicola Ludin
Address 148382 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 148382 0
New Zealand
Phone 148382 0
+642102699212
Fax 148382 0
Email 148382 0
[email protected]
Contact person for public queries
Name 148383 0
Nicola Ludin
Address 148383 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 148383 0
New Zealand
Phone 148383 0
+642102699212
Fax 148383 0
Email 148383 0
[email protected]
Contact person for scientific queries
Name 148384 0
Nicola Ludin
Address 148384 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 148384 0
New Zealand
Phone 148384 0
+642102699212
Fax 148384 0
Email 148384 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Our data set will include Maori data and therefore any requests to access the data, or for proposed use of the data, need to describe how data will be handled and interpreted through a cultural lens.



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.