Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001462178
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
22/10/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
22/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Dream On Study: A randomised controlled trial of efficacy and acceptability of a smart phone application in improving sleep in young people.
Scientific title
Improving sleep in young people using the Sleep Ninja app: A randomised controlled trial of efficacy and acceptability.
Secondary ID [1] 299519 0
Nil known
Universal Trial Number (UTN)
U1111-1241-8949
Trial acronym
Linked study record
This record is a follow-on from the pilot study ACTRN12617000141347.

Health condition
Health condition(s) or problem(s) studied:
Sleep difficulties 314771 0
Depression 314780 0
Anxiety 314781 0
Fatigue 314782 0
Condition category
Condition code
Mental Health 313101 313101 0 0
Other mental health disorders
Mental Health 313112 313112 0 0
Depression
Mental Health 313113 313113 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sleep Ninja app: The Sleep Ninja is a mobile phone application (app) designed for use on iOS (i.e. Apple) and Android (i.e. Samsung) smartphones and is downloaded via the App Store or Google Play. The app was derived from CBT-I, which is the gold standard, evidence-based treatment for insomnia. It includes the following skills and strategies: psychoeducation, sleep scheduling, stimulus control, sleep focused cognitive therapy, sleep hygiene and behavioural activation. The 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. That is, the app is interactive and responsive to user input. The app is based on gaming principles and users progress through six levels or “belts”, starting at a “white belt” and working their way up to “black belt” status. To “level up” and gain the next belt, users must complete one training session (which takes approximately 5 minutes) and at least three nights of sleep tracking within the app’s sleep diary portal, within a 7-day period. At the completion of each level, users are given feedback about their sleep. Users are also given specific advice if they indicate varying their wake-up time by more than two hours from the previous day or recording less than six hours total sleep time. There are additional optional app features that users can access at their choosing, which include a meditation recording, extra sleep information, sleep tips and a “Get Help Now” button that links directly to Australian crisis support services including Kids Helpline. If participants agree to it, the app sends reminder notifications to: enter sleep diaries, begin winding down for sleep, complete training sessions, and return after periods of inactivity. Depending on the frequency of use, participants can take as little as 18 days to progress to “black belt” status.

Participants will have access to the app for 6-weeks.

Adherence is assessed by recording the number of lessons completed, time taken to complete each lesson, and the number of times each section of the app is accessed.
Intervention code [1] 315781 0
Behaviour
Intervention code [2] 315782 0
Treatment: Devices
Comparator / control treatment
The comparator is an active wait-list control group. Wait-listed participants receive weekly sleep tips during the active intervention period and access the app after completing the follow-up assessment, i.e., 14 weeks after completing the baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 321646 0
Insomnia symptoms using the Insomnia severity index (ISI)
Timepoint [1] 321646 0
Baseline, immediately posttreament (primary), 2-month follow-up
Primary outcome [2] 321647 0
Depressive symptoms measured using the Patient Health Questionnaire for Adolescents (PHQ-A)
Timepoint [2] 321647 0
Baseline, immediately posttreatment (primary), 2-month follow-up
Secondary outcome [1] 375734 0
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 375734 0
Baseline, immediately posttreament and 2-month follow-up
Secondary outcome [2] 375735 0
Composite sleep parameters derived from a daily sleep diary (i.e. time in bed; TIB, sleep onset latency; SOL, number of night-time awakenings; NWAK, total duration of time spent awake during the night; WASO, total sleep time; TST, and sleep efficiency; SE)
Timepoint [2] 375735 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [3] 375736 0
Anxiety symptoms as measured using the Generalized Anxiety Disorder – 7 item (GAD-7)
Timepoint [3] 375736 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [4] 375737 0
Symptoms of fatigue, measured using the Flinders Fatigue Scale; FFS
Timepoint [4] 375737 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [5] 375738 0
Levels of daytime sleepiness using the Epworth Sleepiness Scale – Children and Adolescents; ESS-CHAD
Timepoint [5] 375738 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [6] 375739 0
The presence of unhelpful sleep-related behaviours using the Sleep-Related behaviours Questionnaire; (SRBQ)
Timepoint [6] 375739 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [7] 375740 0
Psychological wellbeing using The Short Warwick-Edinburgh Mental Well-being Scale; SWEMWBS)
Timepoint [7] 375740 0
Baseline, immediately posttreatment, 2-month follow-up
Secondary outcome [8] 375768 0
Symptoms of sleep disturbance using the Adolescent Insomnia Questionnaire (AIQ)
Timepoint [8] 375768 0
Baseline, posttreatment, and 2-month follow-up.
Secondary outcome [9] 375934 0
The presence of unhelpful sleep-related thoughts using the Dysfunctional Beliefs and Attitudes about Sleep Scale for Children DBAS-C10,
Timepoint [9] 375934 0
Baseline, posttreatment, and 2-month follow-up.
Secondary outcome [10] 375935 0
The presence of unhelpful sleep-related physiological symptoms using the Pre-Sleep Arousal Scale (PSAS)
Timepoint [10] 375935 0
Baseline, posttreatment, and 2-month follow-up.

Eligibility
Key inclusion criteria
- Aged between 12 and 16 years (inclusive) at time of screening
- Fluent in English
- Own a smartphone (either Apple or Samsung), with capacity for downloading apps
- Have internet access and a valid email address
- Live in Australia
- Score of 10 or greater on the Insomnia Severity Index (ISI)
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- have used the Sleep Ninja app before
- do not have sleep problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using central automated computer-generated software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with a 1:1 allocation, as per a computer-generated schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Analysis of the primary outcome will be undertaken on an intention-to-treat analysis including all participants randomised regardless of intervention received. The primary analysis will be conducted using planned contrasts comparing a change in Insomnia from baseline to post and follow-up, as compared to the control, using a mixed-effects model repeated-measures analysis (MMRM). Secondary outcomes will be analysed using this same approach. Clinical cut-offs on measures will be used to compare likely cases between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2019
Actual
25/10/2019
Date of last participant enrolment
Anticipated
30/04/2020
Actual
5/09/2020
Date of last data collection
Anticipated
31/08/2020
Actual
6/01/2021
Sample size
Target
308
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304013 0
Charities/Societies/Foundations
Name [1] 304013 0
Perpetual Impact
Country [1] 304013 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Hospital Road, Randwick NSW 2031

Country
Australia
Secondary sponsor category [1] 304192 0
None
Name [1] 304192 0
NA
Address [1] 304192 0
NA
Country [1] 304192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304506 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 304506 0
Ethics committee country [1] 304506 0
Australia
Date submitted for ethics approval [1] 304506 0
19/03/2019
Approval date [1] 304506 0
16/04/2019
Ethics approval number [1] 304506 0
HC190139

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

Contacts
Principal investigator
Name 97186 0
Dr Aliza Werner-Seidler
Address 97186 0
Black Dog Institute
Hospital Road, Randwick NSW 2031

Country 97186 0
Australia
Phone 97186 0
+61 2 9382 3803
Fax 97186 0
Email 97186 0
[email protected]
Contact person for public queries
Name 97187 0
Aliza Werner-Seidler
Address 97187 0
Black Dog Institute
Hospital Road, Randwick NSW 2031

Country 97187 0
Australia
Phone 97187 0
+61 2 9382 3803
Fax 97187 0
Email 97187 0
[email protected]
Contact person for scientific queries
Name 97188 0
Aliza Werner-Seidler
Address 97188 0
Black Dog Institute
Hospital Road, Randwick NSW 2031

Country 97188 0
Australia
Phone 97188 0
+61 2 9382 3803
Fax 97188 0
Email 97188 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
Current organisational security guidelines prevent data sharing.


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
SourceTitleYear of PublicationDOI
EmbaseThe effects of a sleep-focused smartphone application on insomnia and depressive symptoms: a randomised controlled trial and mediation analysis.2023https://dx.doi.org/10.1111/jcpp.13795
N.B. These documents automatically identified may not have been verified by the study sponsor.