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.

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.

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.

Validation of questionnaires for restless legs syndrome in the general population: the Trøndelag Health Study (HUNT).

Questionnaires for restless legs syndrome have rarely been validated against face-to-face interviews in the general population. We aimed to validate the modified Norwegian, seven-item Cambridge-Hopkins restless legs syndrome questionnaire and a single diagnostic question for restless legs syndrome. We also aimed to stratify validity at 65 years of age. Among a random sample of 1,201 participants from the fourth wave of the Trøndelag Health Study, 232 (19%) agreed to participate, out of whom 221 had complete data for analyses. Participants completed the questionnaires for restless legs syndrome immediately before attending a face-to-face interview using the latest diagnostic criteria. We calculated sensitivity, specificity, and Cohen's kappa statistic (κ) of questionnaire- versus interview-based diagnoses. We found acceptable validity of the seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome (κ = 0.37, 95% confidence interval [CI] 0.23-0.51) and good validity of the single diagnostic question (κ = 0.47, 95% CI 0.35-0.58). We also found good validity through the combination of modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome items 2 and 5, while item 1 or 2 alone showed only acceptable validity. The single diagnostic question was significantly more valid among those aged <65 years (κ = 0.60 versus κ = 0.26). Both single- and two-item questionnaire-based diagnoses overestimated interview-based restless legs syndrome prevalence. The seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome will be useful for epidemiological studies although low sensitivity may cause underestimation of true restless legs syndrome prevalence in the general population, especially among elderly. Brief questionnaire-based diagnoses of up to three items seem best utilised as an initial screen. Future studies should identify brief and even more valid questionnaire-based diagnoses for restless legs syndrome in order to estimate prevalence accurately in large epidemiological studies.

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.

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.

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.

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.

Validation of insomnia questionnaires in the general population: The Nord-Trøndelag Health Study (HUNT).

The primary aim was to validate questionnaire-based insomnia diagnoses from a modified Karolinska Sleep Questionnaire (KSQ) and the Insomnia Severity Index (ISI), by age category (< or >65 years), against a semi-structured face-to-face interview. Secondary aims were to split validity by diagnostic certainty of the interview and to compare prevalence estimates of questionnaire- and interview-based diagnoses. A total of 232 out of 1,200 invited (19.3%) from the fourth Nord-Trøndelag Health Study (HUNT4) completed questionnaires, including the KSQ and ISI, shortly before attending a face-to-face diagnostic interview for insomnia based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Both a tentative (DSM-5 criteria A-E) and a definite (criteria A-H) interview diagnosis was evaluated. Cohen's kappa statistic quantified questionnaire validity. In all, 33% (95% confidence interval 27-39%) of participants had definite insomnia: 40% of women and 21% of men. The ISI (cut-off 12) and several KSQ-based diagnoses showed very good validity (κ ≤0.74) against the tentative, versus good validity (κ ≤0.61) against the definite interview diagnosis. Short questionnaires, requiring a daytime symptom at least three times a week, may underestimate insomnia prevalence. Validity was consistently higher for persons aged below versus above 65 years (definite insomnia: κ ≤0.64 vs. κ ≤0.56). Our results have implications for epidemiological population-based studies utilising insomnia questionnaires.

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.

The Effect of Reducing Insomnia Severity on Work- and Activity-Related Impairment.

OBJECTIVE/BACKGROUND: The effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) for alleviating sleep problems is well established. However, few studies have explored its impact on work productivity and activity. PARTICIPANTS: Seventy-seven currently employed adults with insomnia disorder (59 females) recruited to a randomized trial of digital versus face-to-face CBT-I. METHODS AND MATERIALS: The general health version of the Work Productivity and Activity Impairment questionnaire was used to measure absenteeism, presenteeism, total work impairment, and activity impairment. We assessed changes in work productivity and activity pre-to-post-therapy for the total sample and then for subgroups categorized according to response or remission of insomnia disorder (evaluated using the Insomnia Severity Index). RESULTS: Study participants showed significant improvements in presenteeism (p = .001; Cohen's d= 0.46), total work impairment (p < .001; d= 0.48), and activity (p < .001; d= 0.66), but not absenteeism (p = .51; d= 0.084) between baseline and follow-up assessment. Individuals meeting criteria for remission showed significantly greater improvement in presenteeism (p = .002), total work impairment (p < .001), and activity (p = .006), but not absenteeism (p = .064). CONCLUSION: This study suggests that the benefits of CBT-I extend beyond improvement in sleep to encompass moderate-to-large improvements in work productivity and activity levels particularly for individuals who achieve remission from insomnia. Given the importance of these behaviors, there is a need for future large-scale randomized trials and cohort studies which should strive to include objective measurement of daytime activity and work performance more frequently.

Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial.

BACKGROUND: Although several large-scale randomised controlled trials have shown the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia. We investigated the effect of a fully automated dCBT-I programme on insomnia severity, sleep-wake patterns, sleep medication use, and daytime impairment. METHODS: We did a parallel-group superiority randomised controlled trial comparing dCBT-I with online patient education about sleep. The interventions were available through a free-to-access website, publicised throughout Norway, which incorporated automated screening, informed consent, and randomisation procedures, as well as outcome assessments. Adults (age ≥18 years) who had regular internet access and scored 12 or higher on the Insomnia Severity Index (ISI) were eligible for inclusion, and were allocated (1:1) to receive dCBT-I (consisting of six core interactive sessions to be completed over 9 weeks) or patient education (control group). Participants were masked to group assignment and had no contact with researchers during the intervention period. The primary outcome was the change in ISI score from baseline to 9-week follow-up, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02558647) and is ongoing, with 2-year follow-up assessments planned. FINDINGS: Between Feb 26, 2016, and July 1, 2018, 5349 individuals commenced the online screening process, of which 1497 were ineligible or declined to participate, 2131 discontinued the screening process, and 1721 were randomly allocated (868 to receive dCBT-I and 853 to receive patient education). At 9-week follow-up, 584 (67%) participants in the dCBT-I group and 534 (63%) in the patient education group completed the ISI assessment. The latent growth model showed that participants in the dCBT-I group had a significantly greater reduction in ISI scores from baseline (mean score 19·2 [SD 3·9]) to 9-week follow-up (10·4 [6·2]) than those in the patient education group (from 19·6 [4·0] to 15·2 [5·3]; estimated mean difference -4·7 (95% CI -5·4 to -4·1; Cohen's d -1·21; p<0·001). Compared with patient education, the number needed to treat with dCBT-I was 2·7 (95% CI 2·4 to 3·2) for treatment response (ISI score reduction ≥8) and 3·2 (2·8 to 3·8) for insomnia remission (ISI score <8). No adverse events were reported to the trial team. INTERPRETATION: dCBT-I is effective in reducing the severity of symptoms associated with the insomnia disorder. These findings support the widespread dissemination of dCBT-I. Future research is needed to identify the moderators of response and to improve targeting. FUNDING: Norwegian Research Council; Liaison Committee for Education, Research and Innovation in Central Norway.

A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions.

BACKGROUND: There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate the use of interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard treatments offered for acute illness episodes of a broad range of diagnoses. To determine the trans-diagnostic generalizability of chronotherapy, we explore the benefits of admitting individuals with an acute illness episode to a psychiatric inpatient unit where changes in light exposure are integrated into the therapeutic environment. METHODS/DESIGN: A two-arm, pragmatic effectiveness, randomized controlled treatment trial, where individuals admitted for acute inpatient psychiatric care will be allocated to a ward with blue-depleted evening light or to a ward with the same layout and facilities but lacking the new lighting technology. The trial will test whether the experimental lighting conditions offer any additional benefits beyond those associated with usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine any differences between groups in the mean duration of hospitalization in days. Additional analyses will compare group differences in symptoms, functioning, medication usage, and side effects and whether length of stay is associated with stability of sleep-wake cycles and circadian rhythms. Ancillary investigations should determine any benefits according to diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of professionals working across both wards. DISCUSSION: This unit offers a unique opportunity to explore how exposure to different lighting conditions may modify sleep-wake cycles and how any changes in sleep-wake cycle may impact on the clinical and functional outcomes of individuals experiencing an acute episode of a severe mental disorder that requires inpatient care. The findings could influence the future design of hospital units offering care to patients with mental or physical disorders. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03788993 . Retrospectively registered on 28 December 2018.