The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial.

OBJECTIVE: This pilot trial aimed to provide evidence for whether the integration of a wearable device with digital behavioral therapy for insomnia (dBTi) improves treatment outcomes and engagement. PARTICIPANTS AND METHODS: One hundred and twenty-eight participants with insomnia symptoms were randomized to a 3-week dBTi program (SleepFix®) with a wearable device enabling sleep data synchronization (dBTi+wearable group; n = 62) or dBTi alone (n = 66). Participants completed the Insomnia Severity Index (ISI) and modified Pittsburgh Sleep Quality Index (PSQI) parameters: wake-after-sleep-onset (WASO), sleep-onset-latency (SOL), and total sleep time (TST) at baseline and weeks 1, 2, 3, and primary endpoint of week 6 and follow-up at 12 weeks. Engagement was measured by the number of daily sleep diaries logged in the app. RESULTS: There was no difference in ISI change scores between the groups from pre- to post-treatment (Cohen's d= 0.7, p= .061). The dBTi+wearable group showed greater improvements in WASO (d= 0.8, p = .005) and TST (d= 0.3, p= .049) compared to the dBTi group. Significantly greater engagement (sleep diary entries) was observed in the dBTi+wearable group (mean = 22.4, SD = 10.0) compared to the dBTi group (mean = 14.1, SD = 14.2) (p = .010). CONCLUSIONS: This pilot trial found that integration of wearable device with a digital insomnia therapy enhanced user engagement and led to improvements in sleep parameters compared to dBTi alone. These findings suggest that adjunctive wearable technologies may improve digital insomnia therapy effectiveness.

Trends in Effectiveness of Organizational eHealth Interventions in Addressing Employee Mental Health: Systematic Review and Meta-analysis.

BACKGROUND: Mental health conditions are considered the leading cause of disability, sickness absence, and long-term work incapacity. eHealth interventions provide employees with access to psychological assistance. There has been widespread implementation and provision of eHealth interventions in the workplace as an inexpensive and anonymous way of addressing common mental disorders. OBJECTIVE: This updated review aimed to synthesize the literature on the efficacy of eHealth interventions for anxiety, depression, and stress outcomes in employee samples in organizational settings and evaluate whether their effectiveness has improved over time. METHODS: Systematic searches of relevant articles published from 2004 to July 2020 of eHealth intervention trials (app- or web-based) focusing on the mental health of employees were conducted. The quality and bias of all studies were assessed. We extracted means and SDs from publications by comparing the differences in effect sizes (Hedge g) in standardized mental health outcomes. We meta-analyzed these data using a random-effects model. RESULTS: We identified a tripling of the body of evidence, with 75 trials available for meta-analysis from a combined sample of 14,747 articles. eHealth interventions showed small positive effects for anxiety (Hedges g=0.26, 95% CI 0.13-0.39; P<.001), depression (Hedges g=0.26, 95% CI 0.19-0.34; P<.001), and stress (Hedges g=0.25, 95% CI 0.17-0.34; P<.001) in employees' after intervention, with similar effects seen at the medium-term follow-up. However, there was evidence of no increase in the effectiveness of these interventions over the past decade. CONCLUSIONS: This review and meta-analysis confirmed that eHealth interventions have a small positive impact on reducing mental health symptoms in employees. Disappointingly, we found no evidence that, despite the advances in technology and the enormous resources in time, research, and finance devoted to this area for over a decade, better interventions are being produced. Hopefully, these small effect sizes do not represent optimum outcomes in organizational settings. TRIAL REGISTRATION: PROSPERO CRD42020185859; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=185859.

Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review.

BACKGROUND: Mobile health (mHealth) apps offer a scalable option for treating sleep disturbances at a population level. However, there is a lack of clarity about the development and evaluation of evidence-based mHealth apps. OBJECTIVE: The aim of this systematic review was to provide evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. METHODS: A systematic search of studies published from the inception of databases through February 2020 was conducted using 5 databases (MEDLINE, Embase, Cochrane Library, PsycINFO, and CINAHL). RESULTS: A total of 6015 papers were identified using the search strategy. After screening, 15 papers were identified that examined the design engineering and clinical implementation and evaluation of 8 different mHealth apps for sleep disturbance. Most of these apps delivered cognitive behavioral therapy for insomnia (CBT-I, n=4) or modified CBT-I (n=2). Half of the apps (n=4) identified adopting user-centered design or multidisciplinary teams in their design approach. Only 3 papers described user and data privacy. End-user acceptability and engagement were the most frequently assessed implementation metrics. Only 1 app had available evidence assessing all 4 implementation metrics (ie, acceptability, engagement, usability, and adherence). Most apps were prototype versions (n=5), with few matured apps. A total of 6 apps had supporting papers that provided a quantitative evaluation of clinical outcomes, but only 1 app had a supporting, adequately powered randomized controlled trial. CONCLUSIONS: This is the first systematic review to synthesize and examine evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. The minimal number of apps with published evidence for design engineering and clinical implementation and evaluation contrasts starkly with the number of commercial sleep apps available. Moreover, there appears to be no standardization and consistency in the use of best practice design approaches and implementation assessments, along with very few rigorous efficacy evaluations. To facilitate the development of successful and evidence-based apps for sleep disturbance, we developed a high-level framework to guide researchers and app developers in the end-to-end process of app development and evaluation.

Evidence accumulation in the integrated and primed Stroop tasks.

We report distributional analyses of response times (RT) in two variants of the color-word Stroop task using manual keypress responses. In the classic Stroop task, in which the color and word dimensions are integrated into a single stimulus, the Stroop congruence effect increased across the quantiles. In contrast, in the primed Stroop task, in which the distractor word is presented ahead of colored symbols, the Stroop congruence effect was manifested solely as a distributional shift, remaining constant across the quantiles. The distributional-shift pattern mirrors the semantic-priming effect that has been reported in semantic categorization tasks. The results are interpreted within the framework of evidence accumulation, and implications for the roles of task conflict and informational conflict are discussed.

Embedding digital sleep health into primary care practice: A triangulation of perspectives from general practitioners, nurses, and pharmacists.

Introduction: While digital health interventions (DHIs) can potentially address the unmet needs for sleep health services, little is known about their implementation in practice. The current study aimed to explore primary care health providers' attitudes and beliefs towards DHIs for sleep and implementation into practice. Methods: A cross-sectional online survey was administered to Australian primary care health professionals: general practitioners (GPs), community nurses, and community pharmacists. Semi-structured interviews were conducted within a sub-sample of participants exploring their experiences with DHIs and perceived barriers/facilitators for embedding DHIs into primary care. Semi-structured interviews were thematically analysed using the framework approach to contextualise survey findings. Results: Ninety-six surveys were returned (GPs = 36, nurses = 30, and pharmacists = 30) and 45 interviews conducted (GPs = 17, nurses = 14, and pharmacists = 14). From the survey, GPs were more likely to endorse familiarity (p = 0.009) and use (p < 0.001) of sleep DHIs in clinical practice than pharmacists and nurses. GPs were more interested in utilising the diagnostic features within a sleep DHI (p = 0.009) compared to other professionals. Thematic analysis of the interviews revealed three major themes, contextualised by profession: (1) Scope for DHIs in Current Practice, (2) Practice Gaps and Training Needs, and (3) Envisioning a Model of Care Using Sleep DHIs. While DHIs can potentially improve care, greater clarity of care pathways and reimbursement structures are needed for integration into practice. Conclusion: Primary care health professionals highlighted the training, care pathway and financial models required to realise the potential for translating findings from efficacy studies for DHIs into primary care to optimise sleep health.

EMPOWERED trial: protocol for a randomised control trial of digitally supported, highly personalised and measurement-based care to improve functional outcomes in young people with mood disorders.

OBJECTIVES: Many adolescents and young adults with emerging mood disorders do not achieve substantial improvements in education, employment, or social function after receiving standard youth mental health care. We have developed a new model of care referred to as 'highly personalised and measurement-based care' (HP&MBC). HP&MBC involves repeated assessment of multidimensional domains of morbidity to enable continuous and personalised clinical decision-making. Although measurement-based care is common in medical disease management, it is not a standard practice in mental health. This clinical effectiveness trial tests whether HP&MBC, supported by continuous digital feedback, delivers better functional improvements than standard care and digital support. METHOD AND ANALYSIS: This controlled implementation trial is a PROBE study (Prospective, Randomised, Open, Blinded End-point) that comprises a multisite 24-month, assessor-blinded, follow-up study of 1500 individuals aged 15-25 years who present for mental health treatment. Eligible participants will be individually randomised (1:1) to 12 months of HP&MBC or standardised clinical care. The primary outcome measure is social and occupational functioning 12 months after trial entry, assessed by the Social and Occupational Functioning Assessment Scale. Clinical and social outcomes for all participants will be monitored for a further 12 months after cessation of active care. ETHICS AND DISSEMINATION: This clinical trial has been reviewed and approved by the Human Research Ethics Committee of the Sydney Local Health District (HREC Approval Number: X22-0042 & 2022/ETH00725, Protocol ID: BMC-YMH-003-2018, protocol version: V.3, 03/08/2022). Research findings will be disseminated through peer-reviewed journals, presentations at scientific conferences, and to user and advocacy groups. Participant data will be deidentified. TRIAL REGISTRATION NUMBER: ACTRN12622000882729.

How patient centric is health policy development? The case of the Parliamentary Inquiry into Sleep Health Awareness in Australia.

Objective Parliamentary inquiries into health-related issues empower everyday Australians to contribute to the development and reform of health policy. We explored how patient and family/carers concerns are translated by this process, using a less well-known disease, narcolepsy, as an example. Methods Written submissions made to the Parliamentary Inquiry into Sleep Health Awareness in Australia 2018 by self-identified patients or family/carers with narcolepsy (n = 13) were extracted and thematically analysed using the Framework Approach. Each submission was systematically coded and abstracted into emergent themes before being evaluated against the final policy recommendations. Results Although patients and their family/carers prioritised issues that affected their daily lives (i.e. mental health sequela, workplace accommodations), the policy recommendations in the report focused mainly on issues of healthcare infrastructure, funding and engagement. Our analysis highlighted several barriers that patients and their family/carers face when contributing to this part of healthcare policy formation. Conclusions Our findings suggest that the parliamentary inquiry process in its current form is not an ideal vehicle by which patients and family/carers can contribute or influence healthcare policy. Despite calling for submissions from patients and their family/carers, the final report and subsequent health policy recommendations made by the inquiry do not appear to be patient-centric or reflective of the submissions written by these stakeholders. Increased transparency, development of processes to balance stakeholder priorities and improved accessibility for stakeholders to participate are needed if health-related parliamentary inquiries are to produce healthcare policy that ultimately meets the needs of patients and family/carers.

A feasibility study of a mobile app to treat insomnia.

Insomnia is a major public health concern. Sleep restriction therapy (SRT) is an effective behavioral treatment but its delivery is impeded by a shortage of trained clinicians. We developed a mobile app delivering SRT to individuals with insomnia. This feasibility study employed a mixed-methods design to examine the engagement, acceptability, and potential efficacy of the mobile app. Fifteen participants diagnosed with insomnia disorder used the mobile app synchronized with a wearable device for 3 weeks. Those who persisted with the study (n = 12) found the mobile app to be highly acceptable and engaging, logging on average 19 nightly sleep diary entries across the 21 day period. Significant improvements were observed for sleep measures (insomnia severity and sleep efficiency) and daytime symptoms (fatigue and sleepiness). The results suggest that a mobile app delivering SRT to individuals with insomnia is engaging, acceptable, and potentially efficacious. Further, a full-scale effectiveness study is warranted.

Insomnia symptoms and short sleep duration predict trajectory of mental health symptoms.

OBJECTIVES: We evaluated whether insomnia symptoms and short or long sleep duration, alone or in combination, are robustly associated with subsequent trajectory of mental health symptoms. METHODS: Participants were 2598 individuals (15 to 94 years of age) with elevated mental health symptoms at baseline (2013-14). Associations of baseline insomnia symptoms and sleep duration with two-year trajectory of mental health were estimated and adjusted for multiple potential confounders. Outcomes included recovery (well at both follow-up timepoints), intermittent symptoms (unwell at one follow-up timepoint), and chronic symptoms (unwell at each follow-up timepoint). RESULTS: Adjusted for age and sex, baseline insomnia symptoms predicted intermittent (OR 1.43, 95% CI 1.15-1.80) and chronic (OR 2.16, 95% CI 1.77-2.68) trajectories of mental health symptoms. Short sleep duration (<6 h and ≥6 to <7 h) only predicted a chronic trajectory (ORs 1.70-2.06). Associations were attenuated but significant after confounder adjustment. Those who experienced both insomnia and short (<7 h) sleep duration had the greatest risk of chronic mental health symptoms (OR 2.35, 95% CI 1.60-3.45). CONCLUSION: A focus on just sleep duration or insomnia symptoms in those with elevated mental health symptoms will not be adequate to address chronicity. Both components of sleep disturbance, and in particular their co-occurrence, should be addressed.

Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study.

BACKGROUND: Mobile health (mHealth) apps demonstrate promise for improving sleep at scale. End-user engagement is a prerequisite for sustained use and effectiveness. OBJECTIVE: We assessed the needs and preferences of those with poor sleep and insomnia to inform the development of an engaging sleep app. METHODS: We triangulated results from qualitative (focus groups and app reviews) and quantitative (online survey) approaches. A total of 2 focus groups were conducted (N=9). An online survey tested themes identified from the focus groups against a larger population (N=167). In addition, we analyzed 434 user reviews of 6 mobile apps available on app stores. RESULTS: Common focus group themes included the need to account for diverse sleep phenotypes with an adaptive and tailored program, key app features (alarms and sleep diaries), the complex yet condescending nature of existing resources, providing rationale for information requested, and cost as a motivator. Most survey participants (156/167, 93%) would try an evidence-based sleep app. The most important app features reported were sleep diaries (148/167, 88%), sharing sleep data with a doctor (116/167, 70%), and lifestyle tracking (107/167, 64%). App reviews highlighted the alarm as the most salient app feature (43/122, 35%) and data synchronization with a wearable device (WD) as the most commonly mentioned functionality (40/135, 30%). CONCLUSIONS: This co-design process involving end users through 3 methods consistently highlighted sleep tracking (through a diary and WD), alarms, and personalization as vital for engagement, although their implementation was commonly criticized in review. Engagement is negatively affected by poorly designed features, bugs, and didactic information which must be addressed. Other needs depend upon the type of user, for example, those with severe insomnia.