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.

Insomnia as a predictor of treatment outcomes in adolescents receiving concentrated exposure treatment for OCD.

BACKGROUND: Research suggests that individuals with obsessive-compulsive disorder (OCD) frequently experience insomnia. Some previous studies have suggested that insomnia may predict treatment outcomes, but the evidence is limited, especially for adolescents. This study examined the prevalence of insomnia in an adolescent OCD patient sample, explored the correlation between OCD and insomnia, and tested whether levels of insomnia at baseline predict outcomes for adolescent patients receiving the Bergen 4-Day Treatment (B4DT) for OCD. METHODS: Forty-three adolescent OCD patients who received B4DT were selected for this study. Treatment outcome was quantified as change in Children Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores across time from pre- to posttreatment and 3-month follow-up. Insomnia symptoms were measured by the Bergen Insomnia Scale (BIS). Linear mixed models were used to examine the relationship between the BIS and changes in CY-BOCS scores. We controlled for symptoms of general anxiety disorder measured by the GAD-7 and depression symptoms measured by the PHQ-9. RESULTS: In this sample, 68.4% of the patients scored above the cutoff for insomnia on the BIS. There was a moderate correlation between baseline CY-BOCS and BIS that did not reach statistical significance (r = .32, p = .051). High BIS scores before treatment were significantly associated with poorer treatment outcomes, as measured by changes in CY-BOCS over time (p = .002). The association between baseline insomnia and change in OCD symptoms remained significant (p = .033) while controlling for GAD-7 and PHQ-9. CONCLUSION: Insomnia is common among adolescents with OCD, and these data suggest that these patients may be at increased risk for poor treatment outcomes. Future research to explore mechanisms and adjunctive treatments is warranted. TRIAL REGISTRATION: The study was approved by the Regional Committee for Medical and Health Research Ethics of Northern Norway (REK Nord: 2023/606482).

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.

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.

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 ).

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.

Mid-Pregnancy Insomnia and its Association with Perinatal Depressive Symptoms: A Prospective Cohort Study.

Objective/Background: Insomnia and depression are disorders that affect many perinatal women and that often are interrelated. The present study aimed to examine concurrent and prospective associations between mid-pregnancy insomnia and depression during mid-pregnancy and 8 weeks postpartum. Furthermore, differences in depression and in the sleep-related characteristics insomnia, chronotype, and sleep efficiency were explored between the two time points (mid-pregnancy versus 8 weeks postpartum), and between primiparous and multiparous participants.Participants/Methods: The study was part of the Norwegian population-based Depression and Anxiety in the Perinatal Period (DAPP) prospective cohort study. Among 539 women that were recruited for participation when receiving a routine ultrasound examination, we analyzed data from hospital birth records and questionnaire responses from pregnancy week 17 and postpartum week 8. We used the Edinburgh Postnatal Depression Scale to measure depression. The Bergen Insomnia Scale, the reduced Horne-Östberg Morningness-Eveningness Questionnaire, and three questions from the Pittsburgh Sleep Quality Index were used to measure the sleep-related characteristics.Results: Mid-pregnancy insomnia was significantly associated with concurrent depression (p < .001), but not with postpartum depression (p = .288), in a linear mixed model with adjustment for several reproductive and psychosocial variables. Sleep efficiency was reduced from mid-pregnancy to postpartum (from 88% to 77%), and primiparous women reported less efficient sleep than multiparous women after childbirth.Conclusions: The results indicate that mid-pregnancy insomnia may be a marker for concurrent depression but not a predictor of postpartum depression. Future research should examine the extent to which treatment of insomnia from mid-pregnancy on reduces both perinatal insomnia and depression.

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.

The chronotherapeutic treatment of bipolar disorders: A systematic review and practice recommendations from the ISBD task force on chronotherapy and chronobiology.

AIMS: To systematically review the literature on the efficacy and tolerability of the major chronotherapeutic treatments of bipolar disorders (BD)-bright light therapy (LT), dark therapy (DT), treatments utilizing sleep deprivation (SD), melatonergic agonists (MA), interpersonal social rhythm therapy (IPSRT), and cognitive behavioral therapy adapted for BD (CBTI-BP)-and propose treatment recommendations based on a synthesis of the evidence. METHODS: PRISMA-based systematic review of the literature. RESULTS: The acute antidepressant (AD) efficacy of LT was supported by several open-label studies, three randomized controlled trials (RCTs), and one pseudorandomized controlled trial. SD showed rapid, acute AD response rates of 43.9%, 59.3%, and 59.4% in eight case series, 11 uncontrolled, studies, and one RCT, respectively. Adjunctive DT obtained significant, rapid anti-manic results in one RCT and one controlled study. The seven studies on MA yielded very limited data on acute antidepressant activity, conflicting evidence of both antimanic and maintenance efficacy, and support from two case series of improved sleep in both acute and euthymic states. IPSRT monotherapy for bipolar II depression had acute response rates of 41%, 67%, and 67.4% in two open studies and one RCT, respectively; as adjunctive therapy for bipolar depression in one RCT, and efficacy in reducing relapse in two RCTs. Among euthymic BD subjects with insomnia, a single RCT found CBTI-BP effective in delaying manic relapse and improving sleep. Chronotherapies were generally safe and well-tolerated. CONCLUSIONS: The outcome literature on the adjunctive use of chronotherapeutic treatments for BP is variable, with evidence bases that differ in size, study quality, level of evidence, and non-standardized treatment protocols. Evidence-informed practice recommendations are offered.

Cognitive performance in DSWPD patients upon awakening from habitual sleep compared with forced conventional sleep.

Difficult early morning awakening is one of the defining symptoms of delayed sleep-wake phase disorder. It is accompanied by low cognitive arousal and drowsiness resulting in difficulty concentrating and focusing attention upon awakening. We designed the current study to quantitate cognitive performance (i.e. omissions, commissions, reaction time [average and variability]) and cognitive domains (i.e. focused attention, sustained attention, impulsivity and vigilance) with Conners' Continuous Performance Test II during both habitual and conventional (00:00-07:00 hr) sleep-wake schedule in young adult patients with delayed sleep-wake phase disorder (n = 20, mean age = 24.8 years, SD = 3.0) and controls (n = 16, mean age = 24.4 years, SD = 3.4). Conners' Continuous Performance Test II was administered after awakening and in the afternoon during both habitual and conventional conditions. In-laboratory polysomnography was performed for 2 nights. We assessed sleep, tiredness, chronotype and depression using questionnaires. Saliva was sampled for dim light melatonin onset measurements. Repeated-measures ANOVAs were applied for the Conners' Continuous Performance Test II measures with group (patient/control), time (afternoon/morning) and condition (habitual/conventional schedule) as fixed factors. Patients with delayed sleep-wake phase disorder had reduced reaction times, especially in the morning, greater response speed variability, and made more omission and commission errors compared with controls. Patients with delayed sleep-wake phase disorder also had reduced focused attention, especially upon forced early awakening. The short total sleep time of patients with delayed sleep-wake phase disorder could not statistically explain this outcome. In conclusion, we observed a state-dependent reduced ability to focus attention upon early morning awakening in patients with delayed sleep-wake phase disorder. Patients also had more omissions, longer reaction time and increased RT variability after habitual sleep, suggesting a possible small cognitive trait dysfunction in delayed sleep-wake phase disorder.

Processes in acceptance and commitment therapy and the rehabilitation of chronic fatigue.

Acceptance and commitment therapy (ACT) has never been tested for patients with chronic fatigue. We aimed to test if a 3.5-week ACT rehabilitation program for patients with chronic fatigue improved quality of life (QoL), fatigue, and psychological flexibility. Further, to test if improvements in QoL and fatigue were associated with improvement in psychological flexibility, and if psychological flexibility explained variance above and beyond maladaptive cognitions typically targeted in CBT for fatigue. Patients (n = 140) who had been on sick leave > 8 weeks due to chronic fatigue received a 3.5-week non-controlled inpatient rehabilitation program based on ACT. A physician and a psychologist examined the patients, assessing medication use and SCID-I diagnoses. Patients completed questionnaires about somatic complaints, psychological complaints, and maladaptive cognitions before and after treatment. At post-treatment, patients reported improved QoL (p < 0.001; g = 1.07) and less fatigue (p < 0.001; g = 1.08), but not increased psychological flexibility (p = 0.6). Changes in psychological flexibility was associated with improved QoL, but not fatigue, in hierarchical regression analyses. When adjusting for other cognitions, changes in fear-avoidance cognitions and all-or-nothing thoughts, but not psychological flexibility, were associated with improved QoL and fatigue. The ACT-based treatment improved QoL and reduced fatigue for patients with chronic fatigue with large effect sizes. Improvement was associated with a reduction in fear-avoidance cognitions and all-or-nothing thoughts, but not psychological flexibility.

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.

Using cross-recurrence quantification analysis to compute similarity measures for time series of unequal length with applications to sleep stage analysis.

Comparing time series of unequal length requires data processing procedures that may introduce biases. This article describes, validates, and applies Cross-Recurrence Quantification Analysis (CRQA) to detect and quantify correlation and coupling among time series of unequal length without prior data processing. We illustrate and validate this application using continuous and discrete data from a model system (study 1). Then we use the method to re-analyze the Sleep Heart Health Study (SHHS), a rare large dataset comprising detailed physiological sleep measurements acquired by in-home polysomnography. We investigate whether recurrence patterns of ultradian NREM/REM sleep cycles (USC) predict mortality (study 2). CRQA exhibits better performance compared with traditional approaches that require trimming, stretching or compression to bring two time series to the same length. Application to the SHHS indicates that recurrence patterns linked to stability of USCs are associated with all-cause mortality even after controlling for other sleep parameters, health, and sociodemographics. We suggest that CRQA is a useful tool for analyzing categorical time series, where the underlying structure of the data is unlikely to result in matching data points-such as ultradian sleep cycles.

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).

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.

Impact of sleep disturbance on patients in treatment for mental disorders.

BACKGROUND: In clinical practice, sleep disturbance is often regarded as an epiphenomenon of the primary mental disorder. The aim of this study was to test if sleep disturbance, independently of primary mental disorders, is associated with current clinical state and benefit from treatment in a sample representative of public mental health care clinics. METHOD: 2246 patients receiving treatment for mental disorders in eight public mental health care centers in Norway were evaluated in a cross-sectional study using patient and clinician reported measures. Patients reported quality of life, symptom severity, and benefit from treatment. Clinicians reported disorder severity, level of functioning, symptom severity and benefit from treatment. The hypothesis was tested using multiple hierarchical regression analyses. RESULTS: Sleep disturbance was, adjusted for age, gender, time in treatment, type of care, and the presence of any primary mental disorder, associated with lower quality of life, higher symptom severity, higher disorder severity, lower levels of functioning, and less benefit from treatment. CONCLUSION: Sleep disturbance ought to be considered a stand-alone therapeutic entity rather than an epiphenomenon of existing diagnoses for patients receiving treatment in mental health care.

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.