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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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

Objective: Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insomnia, and post hoc analyses suggest mood improvements. We undertook the first clinical trial evaluating the efficacy of Internet-delivered cognitive behavioural therapy for insomnia on depressive symptoms as an adjunct to guideline-based treatment of depressive disorders. Methods: Older men undergoing psychiatrist-coordinated treatment for major depressive disorder or dysthymia and who had significant insomnia symptoms were randomised to either adjunctive Internet-delivered cognitive behavioural therapy for insomnia (Sleep Healthy Using The Internet) or online sleep psychoeducation. The primary outcome was change in depressive symptoms (Centre for Epidemiological Studies Depression scale) from baseline to week 12 (post intervention). Secondary outcomes were insomnia and anxiety symptoms. Results: In all, 87 men were randomised (Internet-delivered cognitive behavioural therapy for insomnia = 45; psychoeducation = 42). The mean observed Centre for Epidemiological Studies Depression scale changes by week 12 were 8.2 (standard deviation = 11.5) and 3.9 (standard deviation = 12.8) for Internet-delivered cognitive behavioural therapy for insomnia and psychoeducation, respectively. The adjunctive effect size of 0.35 in favour of Sleep Healthy Using The Internet programme was not statistically significant (group × time difference in the Mixed effect Model Repeat Measurement analysis difference 4.3; 95% confidence interval = [−1.2, 9.8]; p = 0.15). There was a statistically significant effect on insomnia symptoms (group × time p = 0.02, difference 2.7; 95% confidence interval = [0.2, 5.3]; effect size = 0.62). There were no differences in insomnia or depression at 6 months or differential effects on anxiety at any time point. There were no reported adverse trial-related events in the intervention arm. Conclusion: Adjunctive Internet-delivered cognitive behavioural therapy for insomnia for older men being treated for depression can improve insomnia in the short term, without apparent harm. The short-term depressive symptom effect size in this pilot trial was comparable to other adjunctive interventions and may warrant a larger, definitive trial. [ABSTRACT FROM AUTHOR]

Objective: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain unclear. The current paper describes the impact of an Internet-based intervention for insomnia on anxiety, and explores the influence of two cognitive-behavioural constructs – dysfunctional beliefs about sleep and sleep-threat monitoring. Methods: A large-scale, 9-week, two-arm randomised controlled trial (N = 1149) of community-dwelling Australian adults with insomnia and elevated yet subclinical depression symptoms was conducted, comparing a cognitive behavioural therapy–based online intervention for insomnia (Sleep Healthy Using The Internet) with an attention-matched online control intervention (HealthWatch). Symptoms of anxiety were assessed at pretest, posttest, and 6-month follow-up. Dysfunctional beliefs about sleep and sleep threat monitoring were assessed only at pretest. Results: Sleep Healthy Using The Internet led to a greater reduction in anxiety symptoms at both posttest (t724.27 = –6.77, p < 0.001) and at 6-month follow-up (t700.67 = –4.27, p < 0.001) than HealthWatch. At posttest and follow-up, this effect was found to moderated by sleep-threat monitoring (t713.69 = –2.39, p < 0.05 and t694.77 = –2.98, p < 0.01 respectively) but not by dysfunctional beliefs about sleep at either posttest or follow-up (t717.53 = –0.61, p = 0.55 and t683.79 = 0.22, p = 0.83 respectively). Participants in the Sleep Healthy Using The Internet condition with higher levels of sleep-threat monitoring showed a greater reduction in anxiety than those with lower levels from pretest to posttest, (t724.27 = –6.77, p < 0.001) and through to 6-month follow-up (t700.67 = –4.27, p < 0.001). This result remained after controlling for baseline anxiety levels. Conclusion: The findings suggest that online cognitive behavioral therapy interventions for insomnia are beneficial for reducing anxiety regardless of people's beliefs about their sleep and insomnia, and this is particularly the case for those with high sleep-threat monitoring. This study also provides further evidence for cognitive models of insomnia. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis aimed to determine the size of the placebo effect for insomnia symptoms when comparing placebo treatment with no treatment. PsycINFO, MEDLINE, and CINAHL databases were systematically searched for studies allocating participants with insomnia symptoms (diagnosed or self-reported) to receive a placebo that they were led to believe was an active treatment or to a no treatment control group. Thirteen independent studies (n = 566) met inclusion criteria. Meta-analysis indicated a reliable placebo effect whereby placebo treatment led to improved perceived sleep onset latency (SOL; Hedges g = 0.272), total sleep time (TST; Hedges g = 0.322), and global sleep quality (GSQ; Hedges' g = 0.581), when compared with no treatment. There was no effect on objective assessment of SOL, however only a few studies reported this outcome and there were insufficient sample sizes to meta-analyse other objective outcomes. Moderator analysis indicated that the placebo effect for perceived insomnia symptoms was quite consistent across different variables. The present findings provide strong evidence for placebo effects for perceived insomnia symptoms, but not on the only objective measurement with sufficient sample size to meta-analyse, namely objective SOL. This has important implications for the treatment of insomnia symptoms and the design and interpretation of clinical trials for insomnia symptoms. [ABSTRACT FROM AUTHOR]

Background: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes. Methods/Design: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. Discussion: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Summary: The aim of this study was to describe sleep patterns and rate of insomnia according to diagnostic criteria in college and university students, as well as to examine potential changes in sleep problems from 2010 to 2018. Data stemmed from a national student health survey from 2018 for higher education in Norway (the SHoT study), which invited all 162,512 fulltime students in Norway. A total of 50,054 students (69.1% women) aged 18–35 years were included, yielding a response rate of 30.8%. Sleep parameters, reported separately for weekdays and weekends, included calculations of bedtime, rise time, sleep duration, sleep‐onset latency, wake after sleep onset, sleep need and sleep deficit. Insomnia was defined according to the Diagnostic and Statistical Manual of Mental Disorders (5th edn) criteria. For the trend analysis, we used one item measuring difficulties initiating and/or maintaining sleep, over three time points (2010, 2014 and 2018). The results from 2018 showed large weekday–weekend differences across most sleep parameters. Both male and female students obtained a mean sleep duration in the lower end of the normal range on weekdays (7:24 hr), but met their own sleep need and sleep recommendations at weekends (8:25 hr). The overall prevalence of insomnia was 34.2% in women and 22.2% in men. There was a substantial increase in sleep problems from 2010 (22.6%) to 2018 (30.5%), which was especially pronounced in women. We conclude that sleep problems are both prevalent and increasing among students. This warrants attention as a public health problem in this population. [ABSTRACT FROM AUTHOR]

Background: Computerized cognitive behavioral therapy for insomnia (CCBT-I) has a growing evidence base as a stand-alone intervention, but it is less clear what factors may limit its acceptability and feasibility when combined with clinical care.Objective: The purpose of this study was to explore barriers and facilitators to use of an adjunctive CCBT-I program among depressed patients in a psychiatric clinic by using both quantitative and qualitative approaches.Methods: We conducted the qualitative component of the study using face-to-face or telephone interviews with participants who had enrolled in a clinical trial of a CCBT-I program as an adjunctive treatment in a psychiatric clinical setting. In line with the grounded theory approach, we used a semistructured interview guide with new thematic questions being formulated during the transcription and data analysis, as well as being added to the interview schedule. A range of open and closed questions addressing user experience were asked of all study participants who completed the 12-week trial in an online survey.Results: Three themes emerged from the interviews and open questions, consistent with nonadjunctive CCBT-I implementation. Identification with the adjunctive intervention's target symptom of insomnia and the clinical setting were seen as key reasons to engage initially. Persistence was related to factors to do with the program, its structure, and its content, rather than any nonclinical factors. The survey results showed that only the key active behavioral intervention, sleep restriction, was rated as a major problem by more than 15% of the sample. In this clinical setting, the support of the clinician in completing the unsupported program was highlighted, as was the need for the program and clinical treatment to be coordinated.Conclusions: The use of a normally unsupported CCBT-I program as an adjunctive treatment can be aided by the clinician's approach. A key behavioral component of the intervention, specific to insomnia treatment, was identified as a major problem for persistence. As such, clinicians need to be aware of when such components are delivered in the program and coordinate their care accordingly, if the use of the program is to be optimized.Clinicaltrial: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362875&isReview=true (Archived by WebCite at http://www.webcitation.org/6njjhl42X). [ABSTRACT FROM AUTHOR]

Objective: To explore associations between intraindividual variability (IIV) in sleep patterns and sleep problems, lifestyle factors, and mental and physical health in individuals with chronic insomnia.Methods: Cross-sectional study of 1720 adults with chronic insomnia (67.8% female, mean age = 44.5) who completed online self-report questionnaires and kept a sleep diary (for at least 10 out of 14 days). Linear regression analyses examined IIV in sleep patterns as independent variables, and sleep problems, lifestyle factors, and mental and physical health outcomes as dependent variables. Analysis of each sleep variable was separately adjusted for the mean value of the corresponding variable and for selected background factors.Results: IIV in sleep variables was significantly and positively associated with scores on the Insomnia Severity Index (ISI), dysfunctional beliefs and attitudes about sleep (DBAS-16), the Chalder Fatigue Scale (CFQ), body mass index (BMI) and alcohol consumption (AUDIT-C) at study entry. The association between IIV and mental health outcomes (ie the Hospital Anxiety and Depression Scale [HADS] and subjectively reported mental health status [SF-12 Mental health]) were not significant. IIV was associated with higher (ie more positively rated) mean level of sleep quality.Conclusion: IIV of sleep patterns may be a useful construct for understanding subjective experiences of sleep problems, fatigue and health in people with chronic insomnia. Our findings support notions suggesting that IIV offers additional insights beyond those offered by studying mean values alone; however, discordant findings regarding sleep quality highlight the need for further studies to examine the consequences of IIV. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]