Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial.

STUDY OBJECTIVES: To examine if comorbid anxiety and depression symptoms (psychological distress) moderate intervention effect in participants receiving digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in a large-scale randomized controlled trial (RCT), compared to a patient education (PE) control condition. Further, we investigate if dCBT-I reduced levels of psychological distress for those with insomnia and comorbid psychological distress. METHODS: 1721 participants with insomnia completed online assessments of sleep, fatigue and psychological distress, at baseline and at nine-week follow-up. Primary outcome was Insomnia Severity Index (ISI), and secondary outcomes included self-reported sleep (diary), cognition, fatigue, and psychological distress. Participants with psychological distress (HADS>16) were separated from participants without psychological distress. Linear mixed models in SPSS were conducted to test the effects of the intervention. RESULTS: At nine-week follow-up we found no difference in effect of the intervention between those who had comorbid psychological distress vs. those without psychological distress in terms of insomnia severity (p = 0.552) and fatigue (p = 0.744). Both groups had large effect size improvements on insomnia severity (p < 0.001=), small to medium (Cohen d < 0.08) improvements on fatigue (p < 0.01=) and sleep efficiency (p < 0.001), and small improvement on other sleep diary measures, compared to their respective control group. The psychological distress group showed a small, but statistically significant decrease in psychological distress (d = 0.2, p < 0.05) with dCBT-I compared to PE. CONCLUSION: dCBT-I is a viable treatment for Insomnia also for those who have comorbid psychological distress.

Chronotherapy for patients with a depressive episode treated in a public outpatient mental healthcare clinic in Norway: protocol for a randomised controlled trial.

INTRODUCTION: Depression is highly prevalent in outpatients receiving treatment for mental disorders. Treatment as usual (TAU) usually consists of either psychotherapy and/or antidepressant medication and often takes several weeks before clinical effect. Chronotherapy, consisting of sleep deprivation, sleep-wake phase advancement and stabilisation, and light therapy, is a possible addition to TAU that may decrease the time to treatment response. This randomised controlled trial will examine the benefits of adding chronotherapy to TAU compared with TAU alone. METHODS AND ANALYSIS: The trial will include 76 participants with a depressive episode who initiate outpatient treatment at a secondary mental healthcare outpatient clinic at St. Olavs University Hospital. Participants will be randomly allocated 1:1 to either chronotherapy in addition to TAU or TAU alone. Assessments will be performed at baseline, day 3, day 4, day 7, day 14 and weeks 4, 8, 24 and 52, in addition to longer-term follow ups. The main outcome is difference in levels of depressive symptoms after week 1 using the Inventory of Depressive Symptomatology Self-Report. Secondary outcomes include levels of depressive symptoms at other time points, as well as anxiety, health-related quality of life and sleep assessed through subjective and objective measures. ETHICS AND DISSEMINATION: The study protocol has been approved by the Regional Committee for Medical Research Ethics Central Norway (ref: 480812) and preregistered at ClinicalTrials.gov (ref: NCT05691647). Results will be published via peer-reviewed publications, presentations at research conferences and presentations for clinicians and other relevant groups. The main outcomes will be provided separately from exploratory analysis. TRIAL REGISTRATION NUMBER: NCT05691647.

Dysfunctional beliefs and attitudes about sleep (DBAS) mediate outcomes in dCBT-I on psychological distress, fatigue, and insomnia severity.

OBJECTIVE/BACKGROUND: Digital cognitive behavioral therapy for insomnia (dCBT-I) improves several sleep and health outcomes in individuals with insomnia. This study investigates whether changes in Dysfunctional Beliefs and Attitudes about Sleep (DBAS) during dCBT-I mediate changes in psychological distress, fatigue, and insomnia severity. PATIENTS/METHODS: The study presents a secondary planned analysis of data from 1073 participants in a randomized control trial (Total sample = 1721) of dCBT-I compared with patient education (PE). Self-ratings with the Dysfunctional Beliefs and Attitudes about Sleep (DBAS), the Hospital Anxiety Depression Scale (HADS), the Chalder Fatigue Scale (CFQ), and the Insomnia Severity Index (ISI) were obtained at baseline and 9-week follow-up. Hayes PROCESS mediation analyses were conducted to test for mediation. RESULTS AND CONCLUSION: sDBAS scores were significantly reduced at 9-week follow-up for those randomized to dCBT-I (n = 566) compared with PE (n = 507). The estimated mean difference was -1.49 (95% CI -1.66 to -1.31, p < .001, Cohen's d. = 0.93). DBAS mediated all the effect of dCBT-I on the HADS and the CFQ, and 64% of the change on the ISI (Estimated indirect effect -3.14, 95% CI -3.60 to -2.68) at 9-week follow-up compared with PE. Changes in the DBAS fully mediated the effects of dCBT-I on psychological distress and fatigue, and the DBAS partially mediated the effects on insomnia severity. These findings may have implications for understanding how dCBT-I works and highlights the role of changing cognitions in dCBT-I.

Group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial.

BACKGROUND: Insomnia is common in the general population and is a risk factor for ill-health, which highlights the importance of treating insomnia effectively and cost-efficiently. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment due to its long-term effectiveness and few side-effects, but its availability is limited. The aim of this pragmatic, multicentre randomized controlled trial is to investigate the effectiveness of group-delivered CBT-I in primary care compared to a waiting-list control group. METHODS: A pragmatic multicentre randomized controlled trial will be conducted with about 300 participants recruited across 26 Healthy Life Centres in Norway. Participants will complete online screening and provide consent before enrolment. Those who meet the eligibility criteria will be randomized to a group-delivered CBT-I or to a waiting list according to a 2:1 ratio. The intervention consists of four two-hour sessions. Assessments will be performed at baseline, 4 weeks, 3- and 6 months post-intervention, respectively. The primary outcome is self-reported insomnia severity at 3 months post-intervention. Secondary outcomes include health-related quality of life, fatigue, mental distress, dysfunctional beliefs and attitudes about sleep, sleep reactivity, 7-day sleep diaries, and data obtained from national health registries (sick leave, use of relevant prescribed medications, healthcare utilization). Exploratory analyses will identify factors influencing treatment effectiveness, and we will conduct a mixed-method process evaluation to identify facilitators and barriers of participants' treatment adherence. The study protocol was approved by the Regional Committee for Medical and Health Research ethics in Mid-Norway (ID 465241). DISCUSSION: This large-scale pragmatic trial will investigate the effectiveness of group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia, generating findings that are generalizable to day-to-day treatment of insomnia in interdisciplinary primary care services. The trial will identify those who would benefit from the group-delivered therapy, and will investigate the rates of sick leave, medication use, and healthcare utilization among adults who undergo the group-delivered therapy. TRIAL REGISTRATION: The trial was retrospectively registered in the ISRCTN registry (ISRCTN16185698).

Digital cognitive behaviour therapy for insomnia in individuals with self-reported insomnia and chronic fatigue: A secondary analysis of a large scale randomized controlled trial.

Insomnia is associated with fatigue, but it is unclear whether response to cognitive behaviour therapy for insomnia is altered in individuals with co-occurring symptoms of insomnia and chronic fatigue. This is a secondary analysis using data from 1717 participants with self-reported insomnia in a community-based randomized controlled trial of digital cognitive behaviour therapy for insomnia compared with patient education. We employed baseline ratings of the Chalder Fatigue Questionnaire to identify participants with more or fewer symptoms of self-reported chronic fatigue (chronic fatigue, n = 592; no chronic fatigue, n = 1125). We used linear mixed models with Insomnia Severity Index, Short Form-12 mental health, Short Form-12 physical health, and the Hospital Anxiety and Depression Scale separately as outcome variables. The main covariates were main effects and interactions for time (baseline versus 9-week follow-up), intervention, and chronic fatigue. Participants with chronic fatigue reported significantly greater improvements following digital cognitive behaviour therapy for insomnia compared with patient education on the Insomnia Severity Index (Cohen's d = 1.36, p < 0.001), Short Form-12 mental health (Cohen's d = 0.19, p = 0.029), and Hospital Anxiety and Depression Scale (Cohen's d = 0.18, p = 0.010). There were no significant differences in the effectiveness of digital cognitive behaviour therapy for insomnia between chronic fatigue and no chronic fatigue participants on any outcome. We conclude that in a large community-based sample of adults with insomnia, co-occurring chronic fatigue did not moderate the effectiveness of digital cognitive behaviour therapy for insomnia on any of the tested outcomes. This may further establish digital cognitive behaviour therapy for insomnia as an adjunctive intervention in individuals with physical and mental disorders.

Poorer sleep health is associated with altered brain activation during cognitive control processing in healthy adults.

This study investigated how proactive and reactive cognitive control processing in the brain was associated with habitual sleep health. BOLD fMRI data were acquired from 81 healthy adults with normal sleep (41 females, age 20.96-39.58 years) during a test of cognitive control (Not-X-CPT). Sleep health was assessed in the week before MRI scanning, using both objective (actigraphy) and self-report measures. Multiple measures indicating poorer sleep health-including later/more variable sleep timing, later chronotype preference, more insomnia symptoms, and lower sleep efficiency-were associated with stronger and more widespread BOLD activations in fronto-parietal and subcortical brain regions during cognitive control processing (adjusted for age, sex, education, and fMRI task performance). Most associations were found for reactive cognitive control activation, indicating that poorer sleep health is linked to a "hyper-reactive" brain state. Analysis of time-on-task effects showed that, with longer time on task, poorer sleep health was predominantly associated with increased proactive cognitive control activation, indicating recruitment of additional neural resources over time. Finally, shorter objective sleep duration was associated with lower BOLD activation with time on task and poorer task performance. In conclusion, even in "normal sleepers," relatively poorer sleep health is associated with altered cognitive control processing, possibly reflecting compensatory mechanisms and/or inefficient neural processing.

Contact-free radar recordings of body movement can reflect ultradian dynamics of sleep.

This work aimed to evaluate if a contact-free radar sensor can be used to observe ultradian patterns in sleep physiology, by way of a data processing tool known as Locomotor Inactivity During Sleep (LIDS). LIDS was designed as a simple transformation of actigraphy recordings of wrist movement, meant to emphasise and enhance the contrast between movement and non-movement and to reveal patterns of low residual activity during sleep that correlate with ultradian REM/NREM cycles. We adapted the LIDS transformation for a radar that detects body movements without direct contact with the subject and applied it to a dataset of simultaneous recordings with polysomnography, actigraphy, and radar from healthy young adults (n = 12, four nights of polysomnography per participant). Radar and actigraphy-derived LIDS signals were highly correlated with each other (r > 0.84), and the LIDS signals were highly correlated with reduced-resolution polysomnographic hypnograms (rradars >0.80, ractigraph >0.76). Single-harmonic cosine models were fitted to LIDS signals and hypnograms; significant differences were not found between their amplitude, period, and phase parameters. Mixed model analysis revealed similar slopes of decline per cycle for radar-LIDS, actigraphy-LIDS, and hypnograms. Our results indicate that the LIDS technique can be adapted to work with contact-free radar measurements of body movement; it may also be generalisable to data from other body movement sensors. This novel metric could aid in improving sleep monitoring in clinical and real-life settings, by providing a simple and transparent way to study ultradian dynamics of sleep using nothing more than easily obtainable movement data.

Sleep and work functioning in nurses undertaking inpatient shifts in a blue-depleted light environment.

BACKGROUND: Blue-depleted light environments (BDLEs) may result in beneficial health outcomes for hospital inpatients in some cases. However, less is known about the effects on hospital staff working shifts. This study aimed to explore the effects of a BDLE compared with a standard hospital light environment (STLE) in a naturalistic setting on nurses' functioning during shifts and sleep patterns between shifts. METHODS: Twenty-five nurses recruited from St. Olavs Hospital in Trondheim, Norway, completed 14 days of actigraphy recordings and self-reported assessments of sleep (e.g., total sleep time/sleep efficiency) and functioning while working shifts (e.g., mood, stress levels/caffeine use) in two different light environments. Additionally, participants were asked to complete several scales and questionnaires to assess the symptoms of medical conditions and mental health conditions and the side effects associated with each light environment. RESULTS: A multilevel fixed-effects regression model showed a within-subject increase in subjective sleepiness (by 17%) during evening shifts in the BDLE compared with the STLE (p = .034; Cohen's d = 0.49) and an 0.2 increase in number of caffeinated beverages during nightshifts in the STLE compared with the BDLE (p = .027; Cohen's d = 0.37). There were no significant differences on any sleep measures (either based on sleep diary data or actigraphy recordings) nor on self-reported levels of stress or mood across the two conditions. Exploratory between-group analyses of questionnaire data showed that there were no significant differences except that nurses working in the BDLE reported perceiving the lighting as warmer (p = .009) and more relaxing (p = .023) than nurses working in the STLE. CONCLUSIONS: Overall, there was little evidence that the change in the light environment had any negative impact on nurses' sleep and function, despite some indication of increased evening sleepiness in the BDLE. We recommend further investigations on this topic before BDLEs are implemented as standard solutions in healthcare institutions and propose specific suggestions for designing future large-scale trials and cohort studies. TRIAL REGISTRATION: The study was registered before data collection was completed on the ISRCTN website ( ISRCTN21603406 ).

The effects of digital CBT-I on work productivity and activity levels and the mediational role of insomnia symptoms: Data from a randomized controlled trial with 6-month follow-up.

STUDY OBJECTIVES: Cognitive behavioral therapy for insomnia (CBT-I) is a well-established treatment for insomnia, but few studies have explored its impact on work and activity impairment. METHODS: Data stem from 1721 participants enrolled in a randomized controlled trial comparing the efficacy of digital CBT-I compared with Patient Education. Baseline and 6-month follow-up assessments included self-reported ratings of presenteeism and general impairment (Work Productivity and Activity Impairment Questionnaire), and absenteeism (hours of missed work) and employment status. Insomnia was measured using the Insomnia Severity Index (ISI). Mediation analyses were conducted for each outcome with ISI scores at baseline and 9-week follow-up as the mediator. The analyses were adjusted for potential confounders (e.g., sex, age, comorbidities). RESULTS: dCBT-I was found to be associated with reduced activity impairment compared with PE (by 5.6%) but not presenteeism, absenteeism, or changes in employment status. Mediation analysis showed that changes in insomnia severity largely mediated improvements in presenteeism (by 5.4%) and activity impairment (by 5.5%). There were no significant mediational effects on absenteeism or employment status. CONCLUSIONS: This study shows that dCBT-I is not only effective in improving insomnia. But also demonstrates positive effects on work and daily activities in general, supporting the need for increased access to dCBT-I.

Digital cognitive behaviour therapy for insomnia (dCBT-I): Chronotype moderation on intervention outcomes.

Using data from 1721 participants in a community-based randomized control trial of digital cognitive behavioural therapy for insomnia compared with patient education, we employed linear mixed modelling analyses to examine whether chronotype moderated the benefits of digital cognitive behavioural therapy for insomnia on self-reported levels of insomnia severity, fatigue and psychological distress. Baseline self-ratings on the reduced version of the Horne-Östberg Morningness-Eveningness Questionnaire were used to categorize the sample into three chronotypes: morning type (n = 345; 20%); intermediate type (n = 843; 49%); and evening type (n = 524; 30%). Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale were assessed pre- and post-intervention (9 weeks). For individuals with self-reported morning or intermediate chronotypes, digital cognitive behavioural therapy for insomnia was superior to patient education on all ratings (Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale) at follow-up (p-values ≤ 0.05). For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p = 0.139). There were significant differences in the treatment effects between the three chronotypes on the Insomnia Severity Index (p = 0.023) estimated difference between evening and morning type of -1.70, 95% confidence interval: -2.96 to -0.45, p = 0.008, and estimated difference between evening and intermediate type -1.53, 95% confidence interval: -3.04 to -0.03, p = 0.046. There were no significant differences in the treatment effects between the three chronotypes on the Chalder Fatigue Questionnaire (p = 0.488) or the Hospital Anxiety and Depression Scale (p = 0.536). We conclude that self-reported chronotype moderates the effects of digital cognitive behavioural therapy for insomnia on insomnia severity, but not on psychological distress or fatigue.

Using network intervention analysis to explore associations between participant expectations of and difficulties with cognitive behavioural therapy for insomnia and clinical outcome: A proof of principle study.

BACKGROUND: Research about predictors of response to cognitive behaviour therapy for insomnia (CBT-I) is ongoing. We examined any whether pre-intervention expectations or post-intervention appraisals of difficulties in utilizing face to face (FtF) or digital (dCBT-I) versions of the therapy were associated with outcome. METHODS: Self-rating data were extracted on 101 adult participants in a recent randomized controlled trial of FtF versus dCBT-I. Network intervention analyses were used to explore any associations between expectations of CBT-I at response at 9 weeks and between post-intervention ratings of difficulties, modality of therapy and response at 9-weeks and at 6-months. RESULTS: Anticipated and actual difficulties in employing sleep restriction techniques predicted response in all network models. Modality of therapy played a more overt role in the 9-week outcome network, with FtF therapy more robustly associated with response. However, the direct association between FtF therapy and response was not found in the 6-month outcome network. Notable predictors of poor outcome at 9-weeks and 6-month follow-up were difficulties in accommodating CBT-I into work and daily routines and applying the rules of CBT-I. CONCLUSIONS: This network intervention analysis highlights that self-confidence and ability in undertaking sleep restriction is a key active ingredient of CBT-I. Also, benefits and gains from access to the FtF version of this multi-component therapy were more apparent in the short than the longer term. However, it is important that findings from this proof of principle study are confirmed in further studies.

Intraindividual variability in sleep among people with insomnia and its relationship with sleep, health and lifestyle factors: an exploratory study.

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.

Time to put a spotlight on out-patient chronotherapy for depression.

The challenge of identifying efficacious out-patient treatments for depression is amplified by the increasing desire to find interventions that reduce the time to sustained improvement. One potential but underexplored option is triple chronotherapy (TCT). To date, use of TCT has been largely restricted to specialist units or in-patients. Recent research demonstrates that it may be possible to undertake sleep deprivation in out-patient settings, raising the possibility of delivering TCT to broader populations of individuals with depression. Emerging evidence suggests that out-patient TCT is a high-benefit, low-risk intervention but questions remain about how to target TCT and its mechanisms of action. Like traditional antidepressants, TCT probably acts through several pathways, especially the synchronisation of the 'master clock'. Availability of reliable and valid methods of out-patient measurement of intra-individual circadian rhythmicity and light exposure are rate-limiting steps in the wider dissemination of TCT.

Poor sleep quality is associated with greater negative consequences for cognitive control function and psychological health after mild traumatic brain injury than after orthopedic injury.

OBJECTIVE: To test the hypothesis that poor sleep quality has a stronger negative effect on cognitive control function and psychological health after mild traumatic brain injury (mTBI) than after orthopedic injury. METHOD: Patients with mTBI (n = 197) and trauma controls with orthopedic injuries (n = 82) were included in this prospective longitudinal study. The participants (age 16-60) completed three computerized neurocognitive tests assessing response speed and accuracy at 2 weeks and 3 months after injury, as well as questionnaires and interviews assessing sleep quality and psychological distress at 2 weeks, 3 months, and 12 months after injury. Separate Linear Mixed Models (LMMs) for each of the outcome measures (response speed, response accuracy, psychological distress) were performed. RESULTS: We observed a significant interaction effect between poor sleep quality and group (mTBI vs. trauma controls) in the response speed (p = .028) and psychological distress (p = .001) models, driven by a greater negative impact of poor sleep quality on response speed and psychological distress in the mTBI group. We found no such interaction effect for response accuracy (p = .825), and poor sleep quality was associated with worse accuracy to a similar extent for both groups. CONCLUSIONS: Our findings show that poor sleep quality has a more negative impact on cognitive control function and psychological outcome in patients with mTBI, compared to trauma controls. This indicates an increased vulnerability to poor sleep quality in patients who have suffered an mTBI. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy.

STUDY OBJECTIVES: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity. METHODS: Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33. RESULTS: Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was -2.8 (95% CI: -4.8 to -0.8; p = 0.007, Cohen's d = 0.7), and -4.6 at week 9 (95% CI -6.6 to -2.7; p < 0.001), Cohen's d = 1.2. CONCLUSIONS: At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.

Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial.

INTRODUCTION: Insomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive-behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics. METHODS AND ANALYSIS: A parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned. ETHICS AND DISSEMINATION: The study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04621643); Pre-results.

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT.

STUDY OBJECTIVES: Digital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress. METHODS: In a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analyzed using linear mixed modeling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (behavioral indices (BI-Z) and sleep disturbance indices (SI-Z)). RESULTS: dCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = -0.74; 95% confidence interval (CI) -1.04 to -0.52; 13.3%) and HADS (b = -0.40; 95% CI -0.73 to -0.18; 29.2%), while BI-Z mediated minor changes. CONCLUSION: Reductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention. CLINICAL TRIALS: Name: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I Registration number: NCT02558647 URL: https://clinicaltrials.gov/ct2/show/NCT02558647?cond=NCT02558647&draw=2&rank=1.

Distinguishing sleep from wake with a radar sensor: a contact-free real-time sleep monitor.

This work aimed to evaluate whether a radar sensor can distinguish sleep from wakefulness in real time. The sensor detects body movements without direct physical contact with the subject and can be embedded in the roof of a hospital room for completely unobtrusive monitoring. We conducted simultaneous recordings with polysomnography, actigraphy, and radar on two groups: healthy young adults (n = 12, four nights per participant) and patients referred to a sleep examination (n = 28, one night per participant). We developed models for sleep/wake classification based on principles commonly used by actigraphy, including real-time models, and tested them on both datasets. We estimated a set of commonly reported sleep parameters from these data, including total-sleep-time, sleep-onset-latency, sleep-efficiency, and wake-after-sleep-onset, and evaluated the inter-method reliability of these estimates. Classification results were on-par with, or exceeding, those often seen for actigraphy. For real-time models in healthy young adults, accuracies were above 92%, sensitivities above 95%, specificities above 83%, and all Cohen's kappa values were above 0.81 compared to polysomnography. For patients referred to a sleep examination, accuracies were above 81%, sensitivities about 89%, specificities above 53%, and Cohen's kappa values above 0.44. Sleep variable estimates showed no significant intermethod bias, but the limits of agreement were quite wide for the group of patients referred to a sleep examination. Our results indicate that the radar has the potential to offer the benefits of contact-free real-time monitoring of sleep, both for in-patients and for ambulatory home monitoring.

Sleep disturbances and first onset of major mental disorders in adolescence and early adulthood: A systematic review and meta-analysis.

Despite several high-quality reviews of insomnia and incidence of mental disorders, prospective longitudinal relationships between a wider range of sleep disturbances and first onset of a depressive, bipolar, or psychotic disorders during the peak age range for onset of these conditions has not been addressed. Database searches were undertaken to identify publications on insomnia, but also on other sleep problems such as hypersomnia, short sleep duration, self-identified and/or generic 'sleep problems' and circadian sleep-wake cycle dysrhythmias. We discovered 36 studies that were eligible for systematic review and from these publications, we identified 25 unique datasets that were suitable for meta-analysis (Number>45,000; age ∼17). Individuals with a history of any type of sleep disturbance (however defined) had an increased odds of developing a mood or psychotic disorder in adolescence or early adulthood (Odds ratio [OR]:1.88; 95% Confidence Intervals:1.67, 2.25) with similar odds for onset of bipolar disorders (OR:1.72) or depressive disorders (OR:1.62). The magnitude of associations differed according to type of exposure and was greatest for sleep disturbances that met established diagnostic criteria for a sleep disorder (OR: 2.53). However, studies that examined observer or self-rated symptoms, also reported a significant association between hypersomnia symptoms and the onset of a major mental disorder (OR:1.39). Overall study quality was moderate with evidence of publication bias and meta-regression identified confounders such as year of publication. We conclude that evidence indicates that subjective, observer and objective studies demonstrate a modest but significant increase in the likelihood of first onset of mood and psychotic disorders in adolescence and early adulthood in individuals with broadly defined sleep disturbances. Although findings support proposals for interventions for sleep problems in youth, we suggest a need for greater consensus on screening strategies and for more longitudinal, prospective studies of circadian sleep-wake cycle dysrhythmias in youth.

The evening light environment in hospitals can be designed to produce less disruptive effects on the circadian system and improve sleep.

STUDY OBJECTIVES: Blue-depleted lighting reduces the disruptive effects of evening artificial light on the circadian system in laboratory experiments, but this has not yet been shown in naturalistic settings. The aim of the current study was to test the effects of residing in an evening blue-depleted light environment on melatonin levels, sleep, neurocognitive arousal, sleepiness, and potential side effects. METHODS: The study was undertaken in a new psychiatric hospital unit where dynamic light sources were installed. All light sources in all rooms were blue-depleted in one half of the unit between 06:30 pm and 07:00 am (melanopic lux range: 7-21, melanopic equivalent daylight illuminance [M-EDI] range: 6-19, photopic lux range: 55-124), whereas the other had standard lighting (melanopic lux range: 30-70, M-EDI range: 27-63, photopic lux range: 64-136), but was otherwise identical. A total of 12 healthy adults resided for 5 days in each light environment (LE) in a randomized cross-over trial. RESULTS: Melatonin levels were less suppressed in the blue-depleted LE (15%) compared with the normal LE (45%; p = 0.011). Dim light melatonin onset was phase-advanced more (1:20 h) after residing in the blue-depleted LE than after the normal LE (0:46 h; p = 0.008). Total sleep time was 8.1 min longer (p = 0.032), rapid eye movement sleep 13.9 min longer (p < 0.001), and neurocognitive arousal was lower (p = 0.042) in the blue-depleted LE. There were no significant differences in subjective sleepiness (p = 0.16) or side effects (p = 0.09). CONCLUSIONS: It is possible to create an evening LE that has an impact on the circadian system and sleep without serious side effects. This demonstrates the feasibility and potential benefits of designing buildings or hospital units according to chronobiological principles and provide a basis for studies in both nonclinical and clinical populations.