The effects of a sleep-focused smartphone application on insomnia and depressive symptoms: a randomised controlled trial and mediation analysis.

BACKGROUND: Rates of depression are increasing among adolescents. A novel way to reduce depression is by improving sleep. We evaluated whether an app-based intervention for insomnia improved sleep and depression, and whether changes in insomnia mediated changes in depression. METHODS: We conducted a 2-arm single-blind randomised controlled trial at the Black Dog Institute in Australia. Adolescents 12-16 years experiencing insomnia symptoms were randomly allocated to receive Sleep Ninja, an app-delivered cognitive behavioural therapy program for insomnia, or to an active control group involving weekly text message sleep tips. Assessments took place at baseline, 6 weeks (post-intervention) and 14 weeks (post-baseline). Co-primary outcomes were symptoms of insomnia and depression at post-intervention (primary endpoint). Intent-to-treat analyses were conducted. The trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12619001462178. RESULTS: Between October 25, 2019, and September 6, 2020, 264 participants were randomised to receive Sleep Ninja (n = 131) or to the control group (n = 133). Relative to the control group, those allocated to the intervention reported a greater reduction in insomnia symptoms at 6 weeks (95% CI: -2.96 to -0.41, d = .41) and 14 weeks (95% CI: -3.34 to -0.19, d = .39), and a greater reduction in depression symptoms at 6 weeks (95% CI: -3.46 to -0.56, d = .28) but not 14 weeks (p < 1). Change in insomnia mediated change in depression. No adverse events were reported. CONCLUSIONS: An app-delivered program for insomnia could be a practical, non-stigmatising and scalable way to reduce symptoms of insomnia and depression among adolescents experiencing difficulties getting enough good quality sleep.

Factors That Help and Hinder the Implementation of Digital Depression Prevention Programs: School-Based Cross-sectional Study.

BACKGROUND: Digital prevention programs that are delivered in a school environment can inoculate young people against depression. However, little is known about the school-based factors that help and hinder the implementation of these programs. Staff members are integral for supporting mental health programs in schools and are likely to have a wealth of expertise and knowledge about the factors that affect implementation. OBJECTIVE: The primary objective of this study was to explore the barriers and facilitators to implementing a digital depression prevention program in Australian secondary schools with teachers, counselors, and principals. The secondary objective was to explore variations in these factors across different school contexts, including the school type (government or nongovernment), location (capital city, regional/or rural areas), and socioeconomic status (SES) (low, medium, high). METHODS: This quantitative cross-sectional survey study assessed the barriers and facilitators to implementing a hypothetical digital prevention program in Australian schools. The survey was taken by 97 teachers (average age 38.3 years), 93 counselors (average age 39.5 years), and 11 principals (average age 50.9 years) across Australia between November 2017 and July 2018. RESULTS: A range of barriers and facilitators relating to logistics and resources, staff support, and program factors were endorsed by the surveyed staff. Consistent with prior research, common barriers included a lack of time and resources (ie, staff and rooms). These barriers were particularly evident in government, rural/regional, and low socioeconomic schools. Other barriers were specific to digital delivery, including privacy issues and a lack of clarity around staff roles and responsibilities. Facilitators included upskilling staff through training, embedding the program into the curriculum, and other program factors including universal delivery, screening of students' mental health, and clear referral pathways. Knowledge about the program efficacy was also perceived as important by a large proportion of the respondents. CONCLUSIONS: The digital depression prevention program was perceived as suitable for use within different schools in Australia, although certain factors need to be considered to enable effective implementation. Logistics and resources, support, and program factors were identified as particularly important for school-based implementation. To maximize the effectiveness in delivering digital programs, implementation may need to be tailored to the staff roles and school types.

A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

BACKGROUND: Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. METHODS: A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. DISCUSSION: This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Pilot evaluation of the Sleep Ninja: a smartphone application for adolescent insomnia symptoms.

OBJECTIVES: The aim of this study was to test the feasibility, acceptability and preliminary effects of a recently developed smartphone application, Sleep Ninja, for adolescent sleep difficulties. SETTING: The study was conducted online with Australian individuals recruited through the community. PARTICIPANTS: Participants were 50 young people aged 12-16 years with sleep difficulties. DESIGN: A single-arm pre-post design was used to evaluate feasibility, acceptability and sleep and mental health variables at baseline and postintervention. INTERVENTION: Cognitive-behavioural therapy for insomnia informed the development of the Sleep Ninja. The core strategies covered by the app are psychoeducation, stimulus control, sleep hygiene and sleep-related cognitive therapy. It includes six training sessions (lessons), a sleep tracking function, recommended bedtimes based on sleep guidelines, reminders to start a wind-down routine each night, a series of sleep tips and general information about sleep. Users progress through each training session and conclude the 6-week programme with a black belt in sleep. OUTCOME MEASURES: Feasibility was evaluated based on consent rates, adherence and attrition, acceptability was assessed using questionnaires and a poststudy interview, and sleep, depression and anxiety variables were assessed at baseline and postintervention. RESULTS: Data indicated that the Sleep Ninja is a feasible intervention and is acceptable to young people. Findings showed that there were significant improvements on sleep variables including insomnia (within-group effect size d=-0.90), sleep quality (d=-0.46), depression (d=-0.36) and anxiety (d=-0.41). CONCLUSIONS: The Sleep Ninja is a promising intervention that could assist adolescents who experience sleep difficulties. A follow-up randomised controlled trial is now warranted. TRIAL REGISTRATION NUMBER: ACTRN12617000141347.

Digitally-delivered cognitive-behavioural therapy for youth insomnia: A systematic review.

Sleep disturbance is common among young people, with consequences for academic, emotional and behavioural development. Cognitive-behavioural therapy for insomnia (CBT-I) is efficacious, yet it is costly and not available to many who need it. Digitally-delivered CBT-I (eCBT-I) has the potential to overcome these barriers. The purpose of this systematic review was to identify studies which report on the efficacy or effectiveness of eCBT-I for young people with sleep disturbance. Electronic databases were systematically searched and three studies met inclusion criteria. Two studies used the same online intervention for adolescents with insomnia symptoms, while the other was conducted in a college sample of individuals who opted into a stress-management study. Results showed that eCBT-I improved sleep efficiency, sleep quality, sleep-onset latency and total sleep time with effect sizes ranging from 0.17-1.30 (Cohen's d). This suggests that eCBT-I is a promising intervention for young people, but more studies are needed to verify the conditions under which it is most effective.

A Smartphone App for Adolescents With Sleep Disturbance: Development of the Sleep Ninja.

BACKGROUND: Sleep disturbances are common in young people and have consequences for academic, social, emotional, and behavioral development. The most effective treatment is cognitive behavioral therapy for insomnia (CBT-I), with evidence suggesting that it is efficacious even when delivered digitally. OBJECTIVE: There are no commercially available digitally delivered CBT-I programs for use by young people. The aim of this project was to develop a smartphone app that delivers CBT-I to young people to improve sleep. METHODS: To inform the development of the app, young people (N=21) aged between 12 and 16 years attended one of the 3 focus groups (each with 4-10 participants). These focus groups were conducted at different stages of the development process such that the process could be iterative. Participants were asked the reasons why they might use an app to help them sleep, the kinds of features or functions that they would like to see in such an app, and any concerns they may have in using the app. Data were analyzed using a thematic analysis approach. Of the issues discussed by the participants, the researchers selected themes associated with content, functionality, and accessibility and user experience to examine, as these were most informative for the app design process. RESULTS: In terms of content, young people were interested in receiving information about recommended sleep guidelines and personalized information for their age group. They reported that keeping a sleep diary was acceptable, but they should be able to complete it flexibly, in their own time. They reported mixed views about the use of the phone's accelerometer. Young people felt that the functionality of the app should include elements of game playing if they were to remain engaged with the app. Flexibility of use and personalized features were also desirable, and there were mixed views about the schedule of notifications and reminders. Participants reported that for the app to be accessible and usable, it should be from a trusted developer, have engaging aesthetics, have a layout that is easy to navigate, not rely on Internet coverage, and preferably be free. Participants felt that being able to conceal the purpose of the app from peers was an advantage and were willing to provide personal information to use the app if the purpose and use of that information was made clear. Overall, participants endorsed the use of the app for sleep problems among their age group and reported motivation to use it. CONCLUSIONS: The Sleep Ninja is a fully-automated app that delivers CBT-I to young people, incorporating the features and information that young people reported they would expect from this app. A pilot study testing the feasibility, acceptability, and efficacy of the Sleep Ninja is now underway.