Evidence map›Paper›PMID 37730577›Full record

ArticleBMC psychiatry2023

Protocol for a randomised controlled trial evaluating the effect of a CBT-I smartphone application (Sleep Ninja®) on insomnia symptoms in children.

M Subotic-Kerry, A Werner-Seidler, B Corkish, P J Batterham, G Sicouri, J Hudson, H Christensen, B O'Dea, S H Li

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

M Subotic-KerryBlack Dog Institute, University of New South Wales, Sydney, NSW, Australia.
A Werner-SeidlerBlack Dog Institute and School of Psychology, University of New South Wales, Sydney, NSW, Australia.
B CorkishBlack Dog Institute, University of New South Wales, Sydney, NSW, Australia.
P J BatterhamCentre for Mental Health Research, Australian National University, Canberra, Australia.
G SicouriBlack Dog Institute and School of Psychology, University of New South Wales, Sydney, NSW, Australia.
J HudsonBlack Dog Institute and School of Psychology, University of New South Wales, Sydney, NSW, Australia.
H ChristensenFaculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
B O'DeaBlack Dog Institute, University of New South Wales, Sydney, NSW, Australia.
S H LiBlack Dog Institute and School of Psychology, University of New South Wales, Sydney, NSW, Australia. s.h.li@blackdog.org.au.
Black Dog Institute · AUUNSW Sydney · AUAustralian National University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSleep is necessary for healthy development and mental wellbeing. Despite this, many children do not get the recommended duration of sleep each night, and many experience sleep problems. Although treatable, existing interventions for sleep disturbance are time-consuming, burdensome for families, and focus on providing behavioural strategies to parents rather than upskilling children directly. To address this gap, we modified Sleep Ninja®, an evidence-based cognitive behavioural therapy for insomnia (CBT-I) smartphone app for adolescent sleep disturbance, to be appropriate for 10 to 12 year olds. Here, we describe the protocol for a randomised controlled trial to evaluate the effect of Sleep Ninja on insomnia and other outcomes, including depression, anxiety, sleep quality, and daytime sleepiness, and explore effects on the emergence of Major Depressive Disorder (MDD), compared to an active control group.

methodsWe aim to recruit 214 children aged 10 to 12 years old experiencing disturbed sleep. Participants will be screened for inclusion, complete the baseline assessment, and then be randomly allocated to receive Sleep Ninja, or digital psychoeducation flyers (active control) for 6-weeks. The primary outcome, insomnia symptoms, along with depression, anxiety, sleep quality, and daytime sleepiness will be assessed at 6-weeks (primary endpoint), 3-months, and 9-months post-baseline (secondary and tertiary endpoints, respectively). A mixed model repeated measures analytic approach will be used to conduct intention-to-treat analyses to determine whether reductions in insomnia and secondary outcomes are greater for those receiving Sleep Ninja relative to the control condition at the primary and secondary endpoints. The difference in relative risk for MDD onset will be explored at 9-months and compared between conditions. DISCUSSION: This is the first clinical trial examining the effects of a CBT-I smartphone app in children experiencing sleep disturbance. Results will provide empirical evidence about the effects of Sleep Ninja on insomnia and other mental health outcomes.

trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12623000587606). UNIVERSAL TRIAL NUMBER: U1111-1294-4167.

Indexed as

Cognitive Behavioral TherapyDisorders of Excessive SomnolenceMajor Depressive DisorderMobile ApplicationsSleep Initiation and Maintenance DisordersAdolescentAustraliaChildHumansRandomized Controlled Trials as TopicSleepSmartphoneAnxietyChildrenCognitive behaviour therapyDepressionInsomniaMobile application

Identifiers

PMID37730577
PMCPMC10510253
OpenAlexW4386890462

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.