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.

Who benefits from indirect prevention and treatment of depression using an online intervention for insomnia? Results from an individual-participant data meta-analysis.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics. METHODS: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree. RESULTS: IPD were obtained from four of seven eligible studies (N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment (d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up (d = -0.84 [95% CI -1.11 to -0.57]). In the subsample (n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators. CONCLUSIONS: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.

Tai Chi compared with cognitive behavioral therapy and the reversal of systemic, cellular and genomic markers of inflammation in breast cancer survivors with insomnia: A randomized clinical trial.

BACKGROUND: Insomnia contributes to inflammation in breast cancer survivors. This study evaluates whether insomnia treatment reverses inflammation in breast cancer survivors with insomnia. METHODS: Participants (n = 90) were randomized to 3 months of Tai Chi (n = 45) or cognitive behavioral therapy for insomnia (CBT-I)(n = 45), and followed for one year post-intervention to 15 month endpoint. Our previous report found that Tai Chi as compared to CBT-I resulted in similar rates of insomnia response and remission over 15 months. Here, we analyze changes in plasma C-reactive protein and pro- and anti-inflammatory cytokines, Toll-like receptor (TLR)-4 stimulated monocyte production of interleukin (IL)-6 and tumor necrosis factor-α (TNF), and cellular pro-inflammatory and anti-viral gene expression (Conserved Transcriptional Response to Adversity RNA profile; CTRA) over 15 months. RESULTS: Insomnia treatment resulted in decreases in the TLR-4 stimulated monocyte production of IL-6, TNF, and their co-expression, as well as decreases in the CTRA profile, decreases inflammatory gene transcripts, and increases in anti-viral gene transcripts over 15 months (all P's < 0.01). In addition, as compared to CBT-I, Tai Chi resulted in greater decreases in plasma IL-6 (P < 0.05), and greater decreases in TLR-4 activated monocyte production of IL-6 and co-expression of IL-6 and TNF at 15 month endpoint. CBT-I resulted in greater increases in anti-viral gene transcripts. CONCLUSIONS: Administration of either CBT-I or Tai Chi effectively treats insomnia, and shows additional benefits of reducing cellular and genomic markers of inflammation, and increasing anti-viral genomic markers in breast cancer survivors with insomnia. Tai Chi, as compared to CBT-I, yields greater and more durable decreases in systemic- and cellular inflammation. Targeting insomnia might mitigate the risk of inflammation-related co-morbidities in breast cancer survivors.

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.

Pain in your day? Get sleep treatment anyway! The role of pain in insomnia treatment efficacy in women veterans.

Insomnia and pain disorders are among the most common conditions affecting United States adults and veterans, and their comorbidity can cause detrimental effects to quality of life among other factors. Cognitive behavioural therapy for insomnia and related behavioural therapies are recommended treatments for insomnia, but chronic pain may hinder treatment benefit. Prior research has not addressed how pain impacts the effects of behavioural insomnia treatment in United States women veterans. Using data from a comparative effectiveness clinical trial of two insomnia behavioural treatments (both including sleep restriction, stimulus control, and sleep hygiene education), we examined the impact of pain severity and pain interference on sleep improvements from baseline to post-treatment and 3-month follow-up. We found no significant moderation effects of pain severity or interference in the relationship between treatment phase and sleep outcomes. Findings highlight opportunities for using behavioural sleep interventions in patients, particularly women veterans, with comorbid pain and insomnia, and highlight areas for future research.

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.

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.

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.

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.

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-wake state discrepancy does not impair the efficacy of cognitive behavioural therapy for insomnia: Findings from a large clinic sample.

The current study determined the extent to which sleep-wake state discrepancy impairs the efficacy of cognitive behavioural therapy for insomnia in a real-world clinical sample. Sleep-wake state discrepancy occurs when there is an inconsistency between a person's subjective and objective sleep, and is a common phenomenon amongst patients with insomnia. Limited information is available on the effectiveness of cognitive behavioural therapy for insomnia in treating patients who experience significant sleep-wake state discrepancy in "real-world" samples. In the present study, all patients with insomnia received cognitive behavioural therapy for insomnia through an outpatient insomnia program (N = 386; mean age = 51.96 years, SD = 15.62; 65.97% [N = 254] female). Prior to treatment, participants completed a polysomnography sleep study and sleep diary, which was used to calculate sleep-wake state discrepancy. At pre-treatment, post-treatment and 3-month follow-up, participants completed the Insomnia Severity Index and other questionnaires, and 1 week of sleep diaries from which sleep-onset latency, wake after sleep onset and other sleep variables were calculated. There were no differences in self-reported sleep-onset latency, wake after sleep onset or Insomnia Severity Index scores at post-treatment or 3-month follow-up between quintiles of sleep-wake state discrepancy. These results indicate that sleep-wake state discrepancy at pre-treatment does not predict treatment response to cognitive behavioural therapy for insomnia. Future research could examine multi-night assessments of sleep-wake state discrepancy to determine whether variations in discrepancy may relate to pre-treatment insomnia severity and cognitive behavioural therapy for insomnia outcomes.

The clinical effect of digital cognitive behavioural therapy for insomnia in subgroups with depressive and anxiety symptoms: A secondary analysis of a randomized-controlled trial.

Insomnia is a highly prevalent mental disorder, and is often co-occurring with depression and anxiety disorders. Cognitive behavioural therapy for insomnia as treatment of choice for insomnia can also be applied digitally (digital cognitive behavioural therapy for insomnia), making it more accessible. This is a secondary data analysis of a two-armed parallel randomized-controlled trial. In the primary publication, N = 238 participants meeting criteria for the 5th edition of Diagnostic and Statistical Manual of Mental Disorders chronic insomnia disorder were randomly assigned to either 8 weeks of digital cognitive behavioural therapy for insomnia + treatment-as-usual, or waitlist + treatment-as-usual. To determine the clinical effects of digital cognitive behavioural therapy for insomnia in populations with comorbid anxiety and depression symptoms, this secondary analysis focused on two subgroups: (1) participants with high initial depressive symptoms; and (2) participants with high initial anxiety symptoms. Symptoms of insomnia, depression and anxiety as primary outcome measures were obtained at baseline, 8 weeks post-randomization and, in the intervention group only, at 6- and 12-months follow-up. At 8 weeks post-randomization, the use of digital cognitive behavioural therapy for insomnia in both subgroups was associated with large reductions in insomnia severity in comparison to control (depression subgroup: d = 2.37; anxiety subgroup: d = 2.13). Between-group treatment effects were also observed for symptoms of depression in the depression subgroup (d = 1.59), and for symptoms of anxiety in the anxiety subgroup (d = 1.28). Within-group effects were stable over time (d = 0.64-1.63). This secondary analysis shows that digital cognitive behavioural therapy for insomnia reduces insomnia and comorbid symptoms in participants with high initial symptoms of either depression or anxiety with sustained long-term effects.

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.

Investigating the subjective and objective efficacy of a cognitive behavioural therapy for insomnia (CBT-I)-based smartphone app on sleep: A randomised controlled trial.

Due to insufficient treatment options for insomnia, effective solutions are urgently needed. We evaluated the effects of a CBT-I-based app combining sleep training with subjective and objective sleep monitoring on (i) sleep and (ii) subjective-objective sleep discrepancies (SOSD). Fifty-seven volunteers (20-76 years; MAge = 45.67 ± 16.38; 39 female) suffering from sleep problems were randomly assigned to an experimental group (EG, n = 28) or a waitlist control group (CG, n = 29). During the 6-week app phase, the EG used the CBT-I-based programme and a heart rate sensor for daily sleep monitoring and -feedback, while the CG used sleep monitoring only. Sleep was measured (i) subjectively via questionnaires (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), (ii) objectively via ambulatory polysomnography (PSG), and (iii) continuously via heart-rate sensor and sleep diaries. Data revealed interactions for ISI (p = 0.003, ƞ2 part = 0.11) and PSQI (p = 0.050, ƞ2 part = 0.05), indicating training-specific improvements in EG, yet not in CG. While PSG-derived outcomes appear to be less training-specific, a tendential reduction in wake after sleep onset (WASO) was found in EG (p = 0.061, d = 0.55). Regarding changes in SOSD, the results indicate improvements during the app phase (EG) for sleep efficiency, sleep onset latency, and WASO (p ≤ 0.022, d ≥ 0.46); for total sleep time both groups showed a SOSD reduction. The findings indicate beneficial effects of a novel smartphone app on sleep and SOSD. More scientific evaluation of such digital programmes is needed to ultimately help in reducing the gap in non-pharmacological insomnia treatment.

Empowerment-based cognitive behavioural therapy for insomnia in persons with mild cognitive impairment: A sequential explanatory mixed-method pilot study.

Insomnia is an emerging risk factor for the onset of mild cognitive impairment (MCI) and its progression to dementia. Impaired cognition and neuropsychiatric symptoms create challenges for persons with MCI to participate actively in non-pharmacological interventions. This study examined the feasibility and preliminary effects of empowerment-based cognitive-behavioural therapy for insomnia (CBT-I) on sleep, cognitive function, and health-related quality of life (HRQoL) in persons with MCI and sleep problems. Sixty participants were randomly allocated to the intervention or control group to receive empowerment-based CBT-I or usual care, respectively. The 12 week intervention comprised all core CBT-I techniques delivered through a group and individualised face-to-face approach. An empowerment approach with interactive teaching methods, goal setting, and action planning was used to deliver the intervention. Outcome measures included subjective and objective sleep quality and pattern, and a battery of neuropsychological tests and the 12-item Short Form Survey were administered 3 months (T1) and 6 months post-randomisation (T2). This intervention is feasible and highly acceptable for persons with MCI. The intervention group showed significant improvements in subjective and objective sleep-related outcomes compared with the control group. Moreover, the intervention group showed greater improvements in global cognition, processing speed, attention, and mental flexibility than the control group at T1 and/or T2. No significant between-group differences were observed in memory or HRQoL scores. The qualitative data converged with the quantitative data. In conclusion, empowerment-based CBT-I was well received by persons with MCI and had potential positive effects on improving sleep and cognition in this cohort.

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.