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

BACKGROUND: Sleep 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. METHODS: We 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 REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12623000587606). UNIVERSAL TRIAL NUMBER: U1111-1294-4167.

The prevalence of anxiety disorders in dermatology outpatients: A systematic review and meta-analysis.

Anxiety is common in those with medical conditions and has significant impacts on mental well-being as well as physical health outcomes. While several systematic reviews have examined the prevalence of anxiety in specific dermatological conditions, no reviews have examined the prevalence across the entire dermatology outpatient setting. This systematic review aims to provide an overview to dermatologists of the prevalence of, and trends in, anxiety in their outpatient clinics. As such, prevalence of anxiety in dermatology outpatient clinics was examined, and variations across type of anxiety and dermatological conditions were assessed. A search of PubMed, Embase, Cochrane and PsycINFO was conducted for studies that assessed anxiety prevalence in dermatology outpatients, with the last search conducted on 7 September 2022. Results underwent title/abstract and full-text screening, followed by data extraction. Studies of patients 16 years and older and representative of dermatology clinics were included. Risk of bias was assessed using Joanna Briggs Institute Critical Appraisal Checklist. Meta-analysis was conducted using CMA software, and subgroup analysis was conducted on relevant variables. 5423 studies were identified, and 32 included, with a total n = 12,812 participants. Under the random effects model, prevalence was estimated at 26.7% (95%CI 22.4-31.4; 95%PI 9.7-55.4). Subgroup analysis revealed a higher prevalence among studies of psoriasis patients than general dermatology studies. Estimates of prevalence were higher when assessed via self-report screening than diagnostic interview. Anxiety occurred frequently among dermatology outpatients, especially psoriasis outpatients, at a higher rate than common estimates of prevalence in the general population. Given the effect of anxiety on patient outcomes and well-being, dermatologists are encouraged to consider how anxiety may impact patients in their clinic, and how they can best identify patients with anxiety and subsequently support them.