Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

BACKGROUND: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. METHODS: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). FINDINGS: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. INTERPRETATION: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. FUNDING: The National Institute for Health and Care Research Health Technology Assessment Programme.

Stimulus control for insomnia: A systematic review and meta-analysis.

Stimulus control (SC) is commonly viewed as an evidence-based treatment for insomnia, but it has not been evaluated comprehensively with modern review and meta-analytic techniques. The aim of the current study was thus to perform a systematic review and meta-analysis of trials that examine the efficacy of stimulus control for insomnia. A systematic search for eligible articles and dissertations was conducted in six online bibliographic databases. The 11 included studies, with the majority published between 1978 and 1998, were randomised controlled and experimental studies in adults, comparing stimulus control for insomnia with passive and active comparators and assessing insomnia symptoms as outcomes. A random effects model was used to determine the standardised mean difference Hedge's g at post-treatment and follow-up for three sleep diary measures: the number of awakenings, sleep onset latency, and total sleep time. A test for heterogeneity was conducted, forest plots were produced, the risk of publication bias was estimated, and the study quality was assessed. In the trials identified, stimulus control resulted in small to large improvements on sleep onset latency and total sleep time, relative to passive comparators (g = 0.38-0.85). Compared with active comparators, the improvements following stimulus control were negligible (g = 0.06-0.30). Although methodological uncertainties were observed in the included trials, stimulus control appears to be an efficacious treatment for insomnia when compared with passive comparators and with similar effects to active comparators. More robust studies are, however, warranted before stronger conclusions are possible to infer.

Efficacy and safety of digital therapeutic application of Sleep Index-Based Treatment for Insomnia (dSIBT-I): a pilot study.

The aim of this study was to evaluate the safety and efficacy of digital therapeutic application of Sleep Index-Based Treatment for Insomnia (dSIBT-I) and compare them with those of digital application of Cognitive Behavioural Therapy for Insomnia (dCBT-I). This randomised prospective pilot study was conducted at the Asan Medical Center. A total of 50 patients with insomnia were recruited between December 2022 and January 2023 and randomly allocated to the dSIBT-I or dCBT-I group. The study was carried out for one month. The primary outcome was the significant reduction in Insomnia Severity Index score at Week 4 compared to baseline, while the secondary outcome was proportion of participants whose Insomnia Severity Index scores were reduced to <15 at Week 4. We performed linear mixed model and generalised estimating equation analyses. Both dSIBT-I and dCBT-I groups showed significant improvements in Insomnia Severity Index scores at Week 4. There was no significant difference between two groups in terms of Insomnia Severity Index scores at Week 4 (group × time effect, F = 1.07, p = 0.382) and proportion of participants whose Insomnia Severity Index scores were reduced to <15 at Week 4 (group × time effects, F = 1.80, p = 0.615). However, at Week 2, the dSIBT-I group showed better results than the dCBT-I group in terms of both Insomnia Severity Index scores (p = 0.044) and proportion of participants whose Insomnia Severity Index scores were reduced to <15 (82.6% vs. 48.0%, p = 0.017). No treatment-emergent adverse events were reported in either group. The dSIBT-I is a safe and effective therapy for insomnia, with rapid treatment effects.

The effect of sleep restriction therapy for insomnia on REM sleep fragmentation: A secondary analysis of a randomised controlled trial.

Rapid eye movement sleep fragmentation is hypothesised to be a reliable feature of insomnia, which may contribute to emotion dysregulation. Sleep restriction therapy, an effective intervention for insomnia, has the potential to reduce rapid eye movement sleep fragmentation through its manipulation of basic sleep-wake processes. We performed secondary data analysis of a randomised controlled trial to examine whether sleep restriction therapy reduces rapid eye movement sleep fragmentation in comparison to a matched control arm. Participants (n = 56; 39 female, mean age = 40.78 ± 9.08 years) were randomly allocated to 4 weeks of sleep restriction therapy or 4 weeks of time in bed regularisation. Ambulatory polysomnographic recordings were performed at baseline, week 1 and week 4. Arousals during rapid eye movement and non-rapid eye movement sleep were scored blind to group allocation. The following rapid eye movement sleep fragmentation index was the primary outcome: index 1 = (rapid eye movement arousals + rapid eye movement awakenings + non-rapid eye movement intrusions)/rapid eye movement duration in hours. Secondary outcomes were two further indices of rapid eye movement sleep fragmentation: index 2 = (rapid eye movement arousals + rapid eye movement awakenings)/rapid eye movement duration in hours; and index 3 = rapid eye movement arousals/rapid eye movement duration in hours. A non-rapid eye movement fragmentation index was also calculated (non-rapid eye movement arousals/non-rapid eye movement duration in hours). Linear-mixed models were fitted to assess between-group differences. There was no significant group difference for the primary rapid eye movement fragmentation index at week 1 (p = 0.097, d = -0.31) or week 4 (p = 0.741, d = -0.06). There was some indication that secondary indices of rapid eye movement fragmentation decreased more in the sleep restriction therapy group relative to control at week 1 (index 2: p = 0.023, d = -0.46; index 3: p = 0.051, d = -0.39), but not at week 4 (d ≤ 0.13). No group effects were found for arousals during non-rapid eye movement sleep. We did not find clear evidence that sleep restriction therapy modifies rapid eye movement sleep fragmentation. Small-to-medium effect sizes in the hypothesised direction, across several indices of rapid eye movement fragmentation during early treatment, demand further investigation in future studies.

Efficacy of cranial electrotherapy stimulation on mood and sense of well-being in people with subclinical insomnia.

Cranial electrotherapy stimulation is a non-invasive brain stimulation method characterised by using a microcurrent. The objective of the study was to investigate whether a novel device with a stable supplement of electronic stimulation would improve sleep and the accompanying mood symptoms in people with subclinical insomnia. People who had insomnia symptoms without meeting the criteria for chronic insomnia disorder were recruited and randomly assigned to an active or a sham device group. They were required to use the provided device for 30 min each time, twice a day for 2 weeks. Outcome measures included questionnaires for sleep, depression, anxiety, and quality of life, 4 day actigraphy, and 64-channel electroencephalography. Fifty-nine participants (male 35.6%) with a mean age of 41.1 ± 12.0 years were randomised. Improvement of depression (p = 0.032) and physical well-being (p = 0.041) were significant in the active device group compared with the sham device group. Anxiety was also improved in the active device group, although the improvement was not statistically significant (p = 0.090). Regarding sleep, both groups showed a significant improvement in subjective rating, showing no significant group difference. The change in electroencephalography after the 2 week intervention was significantly different between the two groups, especially for occipital delta (p = 0.008) and beta power (p = 0.012), and temporo-parieto-occipital theta (p = 0.022). In conclusion, cranial electrotherapy stimulation can serve as an adjunctive therapy to ameliorate psychological symptoms and to alter brain activity. The effects of the device in a clinical population and an optimal set of parameters of stimulation should be further investigated.

Comparative feasibility and preliminary efficacy of CBT for insomnia among adults seeking and not seeking addiction treatment.

Two out of three adults seeking treatment for alcohol or other substance use disorders report co-occurring symptoms of insomnia. This study compared the feasibility, acceptability, and preliminary efficacy of cognitive behavioural therapy for insomnia (CBT-I) among adults seeking and not seeking treatment for substance use. Adults with alcohol or other substance use disorders (n = 22, 32% female, 82% White; Mage = 39.5) completed assessments at baseline, post-treatment, and at 6 week follow-up. Of those, 11 were and 11 were not enrolled in substance use treatment. All received CBT-I. Multiple imputation was used for missing data. Data were analysed using repeated measures analyses of variance. In the substance use treatment group, 6/11 completed post and 5/11 completed follow-up. In the non-treatment group, 9/11 completed post and 7/11 completed follow-up. Participants in both groups reported improvements in insomnia severity, sleep onset latency, and dysfunctional beliefs about sleep, with most effects evident at post and follow-up. There was a marginal group-by-time interaction in the change in frequency of substance use, with only participants not in substance use treatment reporting decreases at follow-up. Participants in substance use treatment reported significant reductions in substance-related problems and symptoms of post-traumatic stress disorder over time; however, they also reported more symptoms at baseline. CBT-I produces similar reductions in insomnia but is relatively less feasible among individuals in (versus not in) treatment for substance use disorder. This may be due to the more complex logistics of accessing CBT-I among those in treatment. We speculate that integrating CBT-I into treatment for addictions may improve feasibility in this population. clinicaltrials.gov NCT04198311.

The role of rumination in the relationship between symptoms of insomnia and depression in adolescents.

There is a strong relationship between the symptoms of insomnia and depression, however, little is understood about the factors that mediate this relationship. An understanding of these underlying mechanisms may inform the advancement of existing treatments to optimise reductions in insomnia and depression when they co-occur. This study examined rumination and unhelpful beliefs about sleep as mediators between symptoms of insomnia and depression. It also evaluated the effect of cognitive behavioural therapy for insomnia (CBT-I) on rumination and unhelpful beliefs about sleep, and whether these factors mediated the effect of CBT-I on depressive symptoms. A series of mediation analyses and linear mixed modelling were conducted on data from 264 adolescents (12-16 years) who participated in a two-arm (intervention vs. control) randomised controlled trial of Sleep Ninja®, a CBT-I smartphone app for adolescents. Rumination, but not unhelpful beliefs about sleep, was a significant mediator between symptoms of insomnia and depression at baseline. CBT-I led to reductions in unhelpful beliefs about sleep, but not in rumination. At the between-group level, neither rumination, nor unhelpful beliefs about sleep emerged as mechanisms underlying improvement in depression symptoms, however, rumination mediated within-subject improvements following CBT-I. The findings suggest rumination links symptoms of insomnia and depression and provide preliminary evidence that reductions in depression following CBT-I occurs via improvements in rumination. Targeting rumination may improve current therapeutic approaches.

Sleep disruption in adolescent inpatients: prevalence, associations with clinical outcomes, and clinician perspectives.

Sleep problems are common for adolescents with psychiatric disorders, and sleep treatment may aid mental health recovery. Inpatient admissions are likely a particularly challenging time for sleep. Despite this little is known about the nature of sleep problems, and how sleep treatments could be optimised for this setting. This mixed-methods study set out to better understand sleep disturbances in adolescent inpatients. Study 1 examined the prevalence of Sleep Condition Indicator-assessed insomnia at admission and associations with psychiatric symptoms and admission length in 100 inpatients (aged 11-17 years) on one unit in Oxford. Data were gathered from admission routine measures and medical records. Associations were analysed using linear regressions. Half of the inpatients (n = 50) screened positive for insomnia at admission. Moderate-large significant associations were observed between more severe insomnia and more severe depression (ß = -0.56), anxiety (ß = -0.51), self-harm (ß = -0.49), psychotic experiences (ß = -0.32), and conduct problems (ß = -0.30), but not admission length. Study 2 gained 12 clinicians' perspectives on sleep problems on the unit via a focus group and semi-structured interviews, analysed using thematic analysis. Ward staff observed insomnia and excessive daytime sleepiness in adolescent inpatients and a reciprocal relationship with mental health symptoms. Ward processes were barriers (e.g., night-time observations) and facilitators (e.g., regular routines) of sleep. Cognitive behavioural therapy for insomnia was not routinely offered but viewed as potentially helpful. Insomnia may be a common problem for adolescent inpatients, associated with greater psychopathology, but not admission length. The possible benefits of psychological sleep interventions for adolescents admitted to psychiatric units now require testing.

Effect of cognitive behavioural therapy and yoga for generalised anxiety disorder on sleep quality in a randomised controlled trial: the role of worry, mindfulness, and perceived stress as mediators.

Sleep disturbances are present in ~65% of individuals with generalised anxiety disorder (GAD). Although both Kundalini yoga (KY) and cognitive behavioural therapy (CBT) are effective treatment options for GAD, little is known about how these treatments compare in improving sleep for GAD and what drives these changes. Accordingly, we examined the effects of CBT, KY, and stress education (SEdu; an attention control condition) on subjective sleep quality (as measured by the Pittsburgh Sleep Quality Index [PSQI] and Insomnia Severity Index [ISI]) in a randomised controlled trial of 226 adults with GAD (mean age 33.37 years; 70% female; 79% White). We hypothesised that both CBT and KY would outperform SEdu in improving sleep disturbances. Three potential mediators of sleep improvement (worry, mindfulness, perceived stress) were also examined. In line with hypotheses, PSQI and ISI scores significantly improved from pre- to post-treatment for all three treatment groups (all p < 0.001, all d > 0.97). However, contrary to predictions, sleep changes were not significantly greater for CBT or KY compared to SEdu. In mediation analyses, within-person deviations in worry, mindfulness, and stress each significantly mediated the effect of time on sleep outcomes. Degree of change in sleep attributable to worry (CBT > KY > SEdu) and perceived stress (CBT, KY > SEdu) was moderated by treatment group. Personalised medicine as well as combined treatment approaches should be studied to help reduce sleep difficulties for patients with GAD who do not respond.

Preliminary evidence of psychological improvements and increased maternal-fetal attachment associated with a mindfulness sleep programme: secondary analysis of uncontrolled data in 11 pregnant women with insomnia disorder.

Treating insomnia during pregnancy improves sleep and depressed mood. However, given well-established links between poor sleep and a broad spectrum of adverse maternal outcomes, the benefits of insomnia care may reach beyond sleep and depression. The present study evaluated the preliminary efficacy of 'Perinatal Understanding of Mindful Awareness for Sleep' (PUMAS)-a mindfulness sleep programme tailored to pregnancy that combines behavioural sleep strategies and meditation-for enhancing everyday mindfulness and maternal-fetal attachment, as well as for alleviating anxiety, repetitive thinking, and sleep-related daytime impairment. We conducted a secondary analysis of a single-arm proof-of-concept trial of 11 pregnant women with fifth edition of the Diagnostic and Statistical Manual of Mental Disorders diagnosed insomnia disorder who completed PUMAS (six sessions), which was delivered in an individual format via telemedicine video. Pre- and post-treatment outcomes included the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), Maternal-Fetal Attachment Scale (MFAS), Generalised Anxiety Disorder seven-item survey (GAD-7), Perseverative Thinking Questionnaire (PTQ), Daytime Insomnia Symptoms Response Scale (DISRS), and the Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Scale (PROMIS-SRI). Symptom changes were evaluated with paired-samples t tests. Results showed PUMAS patients reported large increases in CAMS-R (Cohen's dz = 1.81) and medium-large increases in MFAS scores (Cohen's dz = 0.73). Moreover, PUMAS patients reported large reductions in scores on the GAD-7 (Cohen's dz = 1.09), PTQ (Cohen's dz = 1.26), DISRS (Cohen's dz = 1.38), and PROMIS-SRI (Cohen's dz = 1.53). Preliminary evidence suggests that a mindfulness-based perinatal sleep programme may benefit several domains of maternal wellbeing beyond sleep and depression. PUMAS substantially enhanced patient ratings of everyday mindfulness and maternal-fetal attachment, while reporting alleviations in anxiety, perseverative thinking, insomnia-focused rumination, and sleep-related daytime impairment.

Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia.

Stroke is frequently accompanied by long-term sleep disruption. We therefore aimed to assess the efficacy of digital cognitive behavioural therapy for insomnia to improve sleep after stroke. A parallel group randomised controlled trial was conducted remotely in participant's homes/online. Randomisation was online with minimisation of between-group differences in age and baseline Sleep Condition Indicator-8 score. In total, 86 community-dwelling stroke survivors consented, of whom 84 completed baseline assessments (39 female, mean 5.5 years post-stroke, mean 59 years old), and were randomised to digital cognitive behavioural therapy or control (sleep hygiene information). Follow-up was at post-intervention (mean 75 days after baseline) and 8 weeks later. The primary outcome was self-reported insomnia symptoms, as per the Sleep Condition Indicator-8 (range 0-32, lower numbers indicate more severe insomnia, reliable change 7 points) at post-intervention. There were significant improvements in Sleep Condition Indicator-8 for digital cognitive behavioural therapy compared with control (intention-to-treat, digital cognitive behavioural therapy n = 48, control n = 36, 5 imputed datasets, effect of group p ≤ 0.02, η p 2 = 0.07-0.12 [medium size effect], pooled mean difference = -3.35). Additionally, secondary outcomes showed shorter self-reported sleep-onset latencies and better mood for the digital cognitive behavioural therapy group, but no significant differences for self-efficacy, quality of life or actigraphy-derived sleep parameters. Cost-effectiveness analysis found that digital cognitive behavioural therapy dominates over control (non-significant cost savings and higher quality-adjusted life years). No related serious adverse events were reported to the researchers. Overall, digital cognitive behavioural therapy for insomnia effectively improves sleep after stroke. Future research is needed to assess earlier stages post-stroke, with a longer follow-up period to determine whether it should be included as part of routine post-stroke care. Clinicaltrials.gov NCT04272892.

A retrospective cost-effectiveness analysis of different cognitive-behavioral therapy for insomnia intervention delivery approaches in adult cancer survivors.

BACKGROUND: Cognitive-behavioral therapy for insomnia (CBT-I) is considered the gold standard treatment for insomnia. Prior trials have delivered CBT-I across a range of treatment sessions. Understanding the economics of varying treatment approaches is essential for future implementation considerations. METHODS: We conducted a retrospective cost-effectiveness analysis from the provider's perspective, comparing the implementation of a three-session CBT-I program for cancer survivors (CBT-I-CS) versus a stepped care treatment approach consisting of an initial single sleep education session followed by CBT-I-CS if elevated insomnia symptoms persisted. The effectiveness measure used was the percentage of participants whose insomnia had remitted by the end of each program. RESULTS: Stepped care delivery was more effective than CBT-I-CS alone, resulting in 35.4% more remitted patients by the end of the overall program. For a $480 willingness to pay threshold per percentage of remitted patients, stepped care CBT-I-CS reached a 98% probability of being cost-effective, while CBT-I-CS alone had only a 2% probability. Larger group sessions in the first step of a stepped care delivery model resulted in more favorable cost-effectiveness. CONCLUSIONS: A stepped care delivery model may be a more cost-effective approach if it can be implemented efficiently. These findings inform policies aimed at improving cancer survivors' access to much-needed insomnia treatment in settings where financial resources for CBT-I may be limited, and be an important barrier to treatment dissemination. CLINICAL TRIAL REGISTRATION: These analyses were not registered.

Efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction for Depression Symptoms and Sleep-Wake Disruption in Older and Younger Adults: Secondary Age-Stratified Analysis of a Randomized Controlled Trial.

OBJECTIVE: Perform a secondary analysis examining the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for depression symptom responses, and explore changes in potential target mechanisms. DESIGN: Secondary analysis of a randomized controlled trial with convenience age subsamples (younger (20-49 year; n = 52) versus and older (50-71 years; n = 35)). SETTING: Community mental health clinics. PARTICIPANTS: Eighty-seven adults with serious mental illness. INTERVENTION: TranS-C versus treatment as usual (TAU). MEASUREMENTS: Outcomes were depression symptoms (Quick Inventory of Depression Symptoms), insomnia symptoms (Insomnia Severity Index), and objective sleep-wake rhythm measures (interdaily stability and relative amplitude). RESULTS: Depression response rates (≥50% symptom reductions) were higher in the TranS-C (35.0%) than the TAU (8.8%) group 6-months postintervention (χ2 = 10.3, p = 0.001). There was a medium effect of TranS-C versus TAU on depression symptoms 6-months postintervention (Cohen's d = -0.40, 95% confidence interval (CI): -0.81, 0.01). In both age groups, there were large treatment effects on insomnia symptoms post-treatment (Cohen's d >0.90). In the older subsample, there were additionally medium treatment effects on post-treatment interdaily stability (Cohen's d = 0.60, 95% CI: -0.11, 1.61). Post-treatment reductions in insomnia symptoms correlated with depression symptom reduction 6-months later in the younger subsample (Spearman rho = 0.59, n = 20, p = 0.008). In older adults, postintervention increases in interdaily stability correlated with depression symptom reductions 6-months later (Spearman rho = -0.52, n = 15, p = 0.049). CONCLUSION: Confirmatory trials are needed, given the low age-specific sample sizes here, to determine if TranS -C's produces durable depression responses by increasing sleep-wake rhythm stability in older adults and improving insomnia symptoms in younger adults. BRIEF ARTICLE SUMMARY: The authors evaluated preliminary efficacy of a behavioral intervention that targets sleep/sleep-wake rhythms, the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), for depression symptoms in people with serious mental illness. TranS-C was associated with higher depression response rates than treatment as usual 6-months postintervention. The degree of depression symptom response 6-months later was related to the degree of treatment phase improvements in interdaily stability (in older adults) and reduction in insomnia severity (in younger adults). A pragmatic nonpharmacologic intervention, the Transdiagnostic Intervention for Sleep and Circadian Dysfunction, has preliminary efficacy for improving sleep-wake factors and depression symptoms.

Longitudinal associations of diurnal rest-activity rhythms with fatigue, insomnia, and health-related quality of life in survivors of colorectal cancer up to 5 years post-treatment.

BACKGROUND: There is a growing population of survivors of colorectal cancer (CRC). Fatigue and insomnia are common symptoms after CRC, negatively influencing health-related quality of life (HRQoL). Besides increasing physical activity and decreasing sedentary behavior, the timing and patterns of physical activity and rest over the 24-h day (i.e. diurnal rest-activity rhythms) could also play a role in alleviating these symptoms and improving HRQoL. We investigated longitudinal associations of the diurnal rest-activity rhythm (RAR) with fatigue, insomnia, and HRQoL in survivors of CRC. METHODS: In a prospective cohort study among survivors of stage I-III CRC, 5 repeated measurements were performed from 6 weeks up to 5 years post-treatment. Parameters of RAR, including mesor, amplitude, acrophase, circadian quotient, dichotomy index, and 24-h autocorrelation coefficient, were assessed by a custom MATLAB program using data from tri-axial accelerometers worn on the upper thigh for 7 consecutive days. Fatigue, insomnia, and HRQoL were measured by validated questionnaires. Confounder-adjusted linear mixed models were applied to analyze longitudinal associations of RAR with fatigue, insomnia, and HRQoL from 6 weeks until 5 years post-treatment. Additionally, intra-individual and inter-individual associations over time were separated. RESULTS: Data were available from 289 survivors of CRC. All RAR parameters except for 24-h autocorrelation increased from 6 weeks to 6 months post-treatment, after which they remained relatively stable. A higher mesor, amplitude, circadian quotient, dichotomy index, and 24-h autocorrelation were statistically significantly associated with less fatigue and better HRQoL over time. A higher amplitude and circadian quotient were associated with lower insomnia. Most of these associations appeared driven by both within-person changes over time and between-person differences in RAR parameters. No significant associations were observed for acrophase. CONCLUSIONS: In the first five years after CRC treatment, adhering to a generally more active (mesor) and consistent (24-h autocorrelation) RAR, with a pronounced peak activity (amplitude) and a marked difference between daytime and nighttime activity (dichotomy index) was found to be associated with lower fatigue, lower insomnia, and a better HRQoL. Future intervention studies are needed to investigate if restoring RAR among survivors of CRC could help to alleviate symptoms of fatigue and insomnia while enhancing their HRQoL. TRIAL REGISTRATION: EnCoRe study NL6904 ( https://www.onderzoekmetmensen.nl/ ).

Psychological Treatment of Comorbid Insomnia and Depression: A Double-Blind Randomized Placebo-Controlled Trial.

INTRODUCTION: Insomnia and depression are highly prevalent disorders and commonly occur together. Cognitive behavioral therapy for insomnia, CBT-I, has been shown to be effective in treating insomnia and also comorbid depression. However, it is unclear whether effects of CBT-I on depression are specific or nonspecific. Also, depressive symptoms often remain too high after CBT-I, indicating a need for improved treatments. The objective was to determine whether combining CBT-I with CBT for depression, without increasing treatment length, reduces both insomnia and depression more than CBT for depression with a placebo insomnia intervention. METHODS: A 12-week double-blind randomized controlled trial with a 6-month follow-up in a psychiatric setting using therapist-guided internet-delivered treatments was conducted. Patients (N = 126) were diagnosed with insomnia disorder and major depression by physicians. Primary outcome measures were as follows: self-rating scales Insomnia Severity Index (ISI) and Montgomery-Åsberg Depression Rating Scale (MADRS-S). RESULTS: The combined treatment showed specific effects on insomnia severity over the control treatment (p = 0.007) but was not more effective in reducing depression severity. Within-group effects (Cohen's d) at post and at 6 months were as follows: ISI 1.40 and 1.42 (combined treatment), 0.95 and 1.00 (control); MADRS-S 0.97 and 1.12 (combined), 0.88 and 0.89 (control). CONCLUSIONS: CBT-I shows large specific effects on insomnia severity and is superior to control in this regard. Both treatments had similar effects on depression severity, i.e., combining CBT-I with CBT for depression did not enhance outcomes on depression compared to control. We suggest CBT-I should always be offered to patients with insomnia and depression comorbidity, possibly as the first-hand choice. Combining it with a psychological treatment for depression could be too burdening and may not be beneficial.

Acceptance and Commitment Therapy, Combined with Bedtime Restriction, versus Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Pilot Trial.

INTRODUCTION: Cognitive behavioral therapy for insomnia (CBT-I) is the current first-line treatment for insomnia. However, rates of nonresponse and nonremission are high and effects on quality of life are only small to moderate, indicating a need for novel treatment developments. We propose that Acceptance and Commitment Therapy (ACT) addresses core pathophysiological pathways of insomnia. ACT therefore has the potential to improve treatment efficacy when combined with bedtime restriction, the most effective component of CBT-I. The aim of this study was to compare the efficacy of ACT for insomnia combined with bedtime restriction (ACT-I) and CBT-I in improving insomnia severity and sleep-related quality of life. METHODS: Sixty-three patients with insomnia disorder (mean age 52 years, 65% female, 35% male) were randomly assigned to receive either ACT-I or CBT-I in a group format. The primary outcomes were insomnia severity (Insomnia Severity Index) and sleep-related quality of life (Glasgow Sleep Impact Index). Outcomes were assessed before randomization (T0), directly after treatment (T1), and at 6-month follow-up (T2). RESULTS: The results indicated significant, large pre-to-post improvements in both groups, for both primary and secondary outcomes. Improvements were maintained at the 6-month follow-up. However, there was no significant group by time interactions in linear mixed models, indicating an absence of differential efficacy. On a subjective treatment satisfaction scale, patients in the ACT-I group indicated significantly greater satisfaction with their improvement of several aspects of health including their energy level and work productivity. CONCLUSIONS: The results suggest that ACT-I is feasible and effective, but not more effective than CBT-I for the improvement of insomnia severity and sleep-related quality of life. Future studies are needed to assess whether ACT-I is noninferior to CBT-I and to shed light on mechanisms of change in both treatments.

Telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy: a feasibility study.

PURPOSE: Sleep quality commonly deteriorates in people receiving chemotherapy for breast cancer (BC). We aimed to determine feasibility and acceptability of telehealth-delivered cognitive behaviour therapy for insomnia (CBT-I) in people with early BC receiving (neo)adjuvant chemotherapy. METHODS: Multi-centre, single arm, phase 2 feasibility trial. People with stage I-III BC received 4 sessions of telehealth CBT-I over 8 weeks, during chemotherapy. Participants completed Pittsburgh Sleep Quality Index (PSQI) and other Patient Reported Outcome Measures (PROMs) at baseline, post-program (week 9) and post-chemotherapy (week 24); and an Acceptability Questionnaire at week 9. Primary endpoint was proportion completing 4 sessions of telehealth CBT-I. RESULTS: In total, 41 participants were recruited: mean age 51 years (range 31-73). All 4 CBT-I sessions were completed by 35 (85%) participants. Acceptability of the program was high and 71% reported 'the program was useful'. There was no significant difference in the number of poor sleepers (PSQI score ≥ 5) at baseline 29/40 (73%) and week 24 17/25 (68%); or in the mean PSQI score at baseline (7.43, SD 4.06) and week 24 (7.48, SD 4.41). From baseline to week 24, 7/25 (28%) participants had a ≥ 3 point improvement in sleep quality on PSQI, and 5/25 (20%) had a ≥ 3 point deterioration. There was no significant difference in mean PROM scores. CONCLUSION: It is feasible to deliver telehealth CBT-I to people with early BC receiving chemotherapy. Contrary to literature predictions, sleep quality did not deteriorate. Telehealth CBT-I has a potential role in preventing and managing sleep disturbance during chemotherapy. Australian New Zealand Clinical Trials Registry (ANZCTR) registration number: ACTRN12620001379909 and date 22/12/2020.

European expert guidance on management of sleep onset insomnia and melatonin use in typically developing children.

Sleeping problems are prevalent among children and adolescents, often leading to frequent consultations with pediatricians. While cognitive-behavioral therapy has shown effectiveness, especially in the short term, there is a lack of globally endorsed guidelines for the use of pharmaceuticals or over-the-counter remedies in managing sleep onset insomnia. An expert panel of pediatric sleep specialists and chronobiologists met in October 2023 to develop practical recommendations for pediatricians on the management of sleep onset insomnia in typically developing children. When sleep onset insomnia is present in otherwise healthy children, the management should follow a stepwise approach. Practical sleep hygiene indications and adaptive bedtime routine, followed by behavioral therapies, must be the first step. When these measures are not effective, low-dose melatonin, administered 30-60 min before bedtime, might be helpful in children over 2 years old. Melatonin use should be monitored by pediatricians to evaluate the efficacy as well as the presence of adverse effects.    Conclusion: Low-dose melatonin is a useful strategy for managing sleep onset insomnia in healthy children who have not improved or have responded insufficiently to sleep hygiene and behavioral interventions.

Developing a novel mobile application for cognitive behavioral therapy for insomnia for people with schizophrenia: integration of wearable and environmental sleep sensors.

BACKGROUND: People with serious mental illnesses (SMIs) have three-fold higher rates of comorbid insomnia than the general population, which has downstream effects on cognitive, mental, and physical health. Cognitive Behavioral Therapy for Insomnia (CBT-i) is a safe and effective first-line treatment for insomnia, though the therapy's effectiveness relies on completing nightly sleep diaries which can be challenging for some people with SMI and comorbid cognitive deficits. Supportive technologies such as mobile applications and sleep sensors may aid with completing sleep diaries. However, commercially available CBT-i apps are not designed for individuals with cognitive deficits. To aid with this challenge, we have developed an integrated mobile application, named "Sleep Catcher," that will automatically incorporate data from a wearable fitness tracker and a bed sensor to track nightly sleep duration, overnight awakenings, bed-times, and wake-times to generate nightly sleep diaries for CBT-i. METHODS: The application development process will be described-writing algorithms to generating useful data, creating a clinician web portal to oversee patients and the mobile application, and integrating sleep data from device platforms and user input. RESULTS: The mobile and web applications were developed using Flutter, IBM Code Engine, and IBM Cloudant database. The mobile application was developed with a user-centered approach and incremental changes informed by a series of beta tests. Special user-interface features were considered to address the challenges of developing a simple and effective mobile application targeting people with SMI. CONCLUSION: There is strong potential for synergy between engineering and mental health expertise to develop technologies for specific clinical populations. Digital health technologies allow for the development of multi-disciplinary solutions to existing health disparities in vulnerable populations, particularly in people with SMI.

Well-being therapy and sleep hygiene in a non-clinical population of adults reporting poor sleep quality and distress: A remote pilot randomized controlled study.

OBJECTIVES: This pilot randomized controlled study evaluates the feasibility and preliminary efficacy of a 7-week remote intervention combining well-being therapy and sleep hygiene to improve sleep and psychological outcomes among adults reporting poor sleep and distress. METHODS: Thirty-one participants (81% women, 40.2 ± 13.0 y, 48% racial/ethnic minority) were recruited from the community during the COVID-19 pandemic through online and local advertisement, and randomized to well-being therapy+sleep hygiene or sleep hygiene-only. Study outcomes were evaluated by self-reported questionnaires administered at baseline and post-intervention and a daily sleep diary. RESULTS: Compared to sleep hygiene-only, well-being therapy+sleep hygiene led to greater improvements in wake after sleep onset (time-by-group interaction: 3.6 ± 1.5 min, p = .017), personal growth (ß -3.0, 95%CI -5.2, -0.8, p = .01), and purpose in life (ß -3.5, 95%CI -6.1, -0.9, p = .009). Anxiety, perceived stress, sleep quality, and insomnia symptoms improved similarly in both groups (between-group differences, p > .05). Improvements in sleep quality, insomnia, and sleep duration were associated with reductions in multiple measures of psychological distress (all p < .05). CONCLUSIONS: These findings suggest that, in a non-clinical setting of individuals suffering from combined poor sleep and psychological distress, the addition of well-being therapy to sleep hygiene may provide additional benefits for sleep by promoting sleep continuity and well-being.