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

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

Treating insomnia symptoms with medicinal cannabis: a randomized,crossover trial of the efficacy of a cannabinoid medicine compared with placebo

Study ObjectivesThis randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).MethodsCo-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.ResultsTwenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (−5.07 units [95% CI: −7.28 to −2.86]; p = 0.0001) and self-reported SOL (−8.45 min [95% CI: −16.33 to −0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (−10.2 min [95% CI: −16.2 to −4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).ConclusionsTwo weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.Clinical TrialANZCTR; anzctr.org.au; ACTRN12618000078257.     

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial

Background

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I.

Aim

To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia.

Design and setting

Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand.

Method

Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined ‘insomnia remission’ treatment response was calculated.

Results

Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference −2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects.

Conclusion

SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.     

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission

Study ObjectivesSleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.MethodsThis secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi—Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.ResultsAt post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).ConclusionsFindings demonstrate that an Internet-delivered CBT-I program can effectively increase users’ sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT00328250","term_id":"NCT00328250"}}NCT00328250     

Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic

Study ObjectivesStressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic.MethodsCOVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016–2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic.ResultsInsomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition.ConclusionsThose who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT02988375","term_id":"NCT02988375"}}NCT02988375     

Mendelian randomization highlights insomnia as a risk factor for pain diagnoses

Study ObjectiveInsomnia has been linked to acute and chronic pain conditions; however, it is unclear whether such relationships are causal. Recently, a large number of genetic variants have been discovered for both insomnia and pain through genome-wide association studies (GWASs) providing a unique opportunity to examine the evidence for causal relationships through the use of the Mendelian randomization paradigm.MethodsTo elucidate the causality between insomnia and pain, we performed bidirectional Mendelian randomization analysis in FinnGen, where clinically diagnosed ICD-10 categories of pain had been evaluated. In addition, we used measures of self-reported insomnia symptoms. We used endpoints for pain in the FinnGen Release 5 (R5) (N = 218,379), and a non-overlapping sample for insomnia (UK Biobank (UKBB) and 23andMe, N = 1,331,010 or UKBB alone N = 453,379). We assessed the robustness of results through conventional Mendelian randomization sensitivity analyses.ResultsGenetic liability to insomnia symptoms increased the odds of reporting pain (odds ratio (OR) [95% confidence interval (CI)] = 1.47 [1.38–1.58], p = 4.12 × 10⁻²⁸). Manifested pain had a small effect on increased risk for insomnia (OR [95% CI] = 1.04 [1.01–1.07], p < 0.05). Results were consistent in sensitivity analyses.ConclusionsOur findings support a bidirectional causal relationship between insomnia and pain. These data support a further clinical investigation into the utility of insomnia treatment as a strategy for pain management and vice versa.     

Insomnia in the context of short sleep increases suicide risk

Study ObjectivesThe relationship between insomnia and suicide risk is not completely understood. We aimed to investigate the influence of insomnia on suicide risk, taking both sleep duration and depression into consideration.MethodsThe present study is based on a Swedish prospective cohort study of 38,786 participants with a mean follow-up time of 19.2 years. Cox proportional hazards models with attained age as time-scale were used to estimate hazard ratios (HRs) of death by suicide with 95% confidence intervals (CI) for participants categorized by frequency of insomnia symptoms. Causal mediation analysis was performed to assess to what extent the relationship between insomnia and suicide risk is mediated by depression.ResultsInsomnia was only associated with suicide risk among short sleepers, whereas no significant association was observed among those who slept 7 h/night or more. The total effect of insomnia in the context of short sleep on suicide risk, expressed on the HR scale, was 2.85 (95% CI 1.42–5.74). The direct effect was 2.25 (95% CI 1.12–4.54) and the indirect effect, mediated by depression, was 1.27 (95% CI 1.05–1.53). Of the total effect, 32% was mediated by depression. The association between insomnia and suicide risk became more pronounced with decreasing depressive symptoms (p value for trend <0.05).ConclusionsInsomnia in the context of short sleep increases suicide risk, both directly and indirectly by affecting the risk of depression. Abnormalities of sleep duration and insomnia symptoms should be evaluated when assessing suicide risk.     

Gender differences in the association of insomnia symptoms and coronary artery calcification in the multi-ethnic study of atherosclerosis

Study ObjectivesTo quantify the gender-specific associations between insomnia symptoms and subclinical atherosclerosis, measured by coronary artery calcium (CAC) scores, which has strong predictive value for incident cardiovascular disease.MethodsWe analyzed data from 1,429 participants in the Multi-Ethnic Study of Atherosclerosis (MESA). Participants completed standardized questionnaires and underwent polysomnography (PSG) and 7-day actigraphy. Insomnia symptoms were defined as: self-reported trouble falling, staying or returning to sleep, early-morning awakenings, or hypnotic use, for ≥5 nights/week. MESA assessed CAC using computed tomography. We employed multivariable linear regression to model the probability of CAC >0 overall and to model the linear continuous effect among those with nonzero CAC.ResultsOur sample was a mean age of 68.1 ± 9.1 years, 53.9% female, and 36.2% white, 28.0% black, 24.2% Hispanic, and 11.5% Chinese-American. Insomnia symptoms were present in 49.7% of men and 47.2% of women. In multivariable-adjusted analyses, insomnia symptoms was associated with an 18% higher prevalence of CAC (PR 1.18, 95% CI 1.04, 1.33) among females, but no association was observed among males (PR 1.00, 95% CI 0.91, 1.08). There was no evidence that the association between insomnia symptoms and prevalence of CAC >0 differed by objective sleep duration status (by single-night PSG or multi-night actigraphy) in females or males.ConclusionsWe found that among women, insomnia symptoms were associated with an 18% higher prevalence of CAC compared to no insomnia. Insomnia symptoms were not associated with CAC prevalence in men. Additionally, there was no evidence that the association between insomnia symptoms and CAC score >0 differed by objective short sleep duration status.     

Insomnia with objective short sleep duration is associated with cognitive impairment: a first look at cardiometabolic contributors to brain health

Study ObjectivesInsomnia with objective short sleep duration has been previously associated with adverse cardiometabolic health outcomes as well as poorer cognitive performance in otherwise noncognitively impaired adults. However, studies demonstrating an increased prevalence of cognitive impairment (CI) in this insomnia phenotype are lacking.MethodsWe analyzed data from Penn State Adult Cohort (N = 1,524; 48.9 ± 13.4 years; 53.4% women). Self-reported sleep difficulty was defined as normal sleep (n = 899), poor sleep (n = 453), and chronic insomnia (n = 172). Objective short sleep duration was defined as less than 6-h of sleep, based on in-lab, 8-h polysomnography. CI (n = 155) and possible vascular cognitive impairment (pVCI, n = 122) were ascertained using a comprehensive neuropsychological battery. Analyses adjusted for age, sex, race, education, body mass index, apnea/hypopnea index, smoking, alcohol, psychoactive medication, and mental and physical health problems.ResultsParticipants who reported poor sleep or chronic insomnia and slept objectively less than 6 hours were associated with a 2-fold increased odds of CI (OR = 2.06, 95% confidence limits [CL] = 1.15–3.66 and OR = 2.18, 95% CL = 1.07–4.47, respectively) and of pVCI (OR = 1.94, 95% CL = 1.01–3.75 and OR = 2.33, 95% CL = 1.07–5.06, respectively). Participants who reported poor sleep or chronic insomnia and slept objectively more than 6 hours were not associated with increased odds of either CI (OR = 0.72, 95% CL = 0.30–1.76 and OR = 0.75, 95% CL = 0.21–2.71, respectively) or pVCI (OR = 1.08, 95% CL = 0.42–2.74 and OR = 0.76, 95% CL = 0.16–3.57, respectively).ConclusionsInsomnia with objective short sleep duration is associated with an increased prevalence of CI, particularly as it relates to cardiometabolic health (i.e. pVCI). These data further support that this insomnia phenotype may be a more biologically severe form of the disorder associated with cardiovascular, cerebrovascular, and neurocognitive morbidity.     

Efficacy of cognitive behavioural therapy for insomnia or sleep disturbance in pregnant women: A systematic review ad meta-analysis

During pregnancy many women may experience negative emotions and sleep disturbances. This systematic review and meta-analysis was conducted to assess the efficacy of cognitive behavioural therapy for insomnia (CBT-I) or sleep disturbance in pregnant women. From the earliest available publications to 15 April 2022, seven electronic literature databases were searched: PubMed, Web of Science, Cochrane Library, Embase, Chinese National Knowledge Infrastructure, Wanfang Data, and VIP Database for Chinese Science and Technology Journal. Randomised controlled trials of CBT-I in pregnant women with insomnia or sleep disorders were included. The methodological bias of the included studies was assessed using the Cochrane risk of bias tool. The meta-analysis was performed using RevMan 5.4 software. Stata Statistical Software: Release 15 was used for sensitivity analysis and publication bias. We included eight randomised controlled trials involving 743 pregnant women. Meta-analysis showed that, compared with the control group, CBT-I significantly improved the Insomnia Severity Index (mean difference [MD] = −4.25, 95% confidence interval [CI, −6.32, −2.19], p < 0.001), The Pittsburgh Sleep Quality Index (MD = −3.30, 95% CI [−4.81, −1.79], p < 0.001), sleep onset latency (standardised mean difference [SMD] = −1.25, 95% CI [−2.01, −0.50], p = 0.001), anxiety (SMD = −0.99, 95% CI [−1.32, −0.67], p < 0.001), and depression (SMD = −0.40, 95% CI [−0.72, −0.07], p = 0.02). No significant differences were found in total sleep time (SMD = 0.31, 95% CI [−0.54, 1.17], p = 0.47) and sleep efficiency (SMD = 0.80, 95% CI [−0.53, 2.13], p = 0.24). CBT-I significantly improved pregnant women's sleep quality, insomnia severity, depression, and anxiety. This meta-analysis provides evidence that CBT-I is valid for insomnia or sleep disturbances during pregnancy.     

Dynamics of sleep,sedentary behavior,and moderate-to-vigorous physical activity on school versus nonschool days

Study ObjectivesStudies examining time-use activity behaviors (sleep, sedentary behavior, and physical activity) on school days compared with nonschool days have examined these behaviors independently, ignoring their interrelated nature, limiting our ability to optimize the health benefits of these behaviors. This study examines the associations of school-day (vs. nonschool day) with time-use activity behaviors.MethodsTime series data (6,642 days) from Fitbits (Charge-2) were collected (n = 196, 53% female, 5–10 years). We used a variable-centered dynamic structural equation modeling approach to estimate day-to-day associations of time-use activity behaviors on school days for each child. We then used person-centered cluster analyses to group individuals based on these estimates.ResultsWithin-participant analysis showed that on school days (vs. nonschool days), children (1) slept less (β = −0.17, 95% CI = −0.21, −0.13), (2) were less sedentary (β = −0.05, 95% CI = −0.09, −0.02), and (3) had comparable moderate-to-vigorous physical activity (MVPA; β = −0.05, 95% CI = −0.11, 0.00). Between-participant analysis showed that, on school days, children with higher sleep carryover experienced greater decreases in sleep (β = 0.44, 95% CI = 0.08, 0.71), children with higher body mass index z-score decreased sedentary behavior more (β = −0.41, 95% CI = −0.64, −0.13), and children with lower MVPA increased MVPA more (β = −0.41, 95% CI −0.64, −0.13). Cluster analysis demonstrated four distinct patterns of connections between time-use activity behaviors and school (High Activity, Sleep Resilient, High Sedentary, and Dysregulated Sleep).ConclusionsUsing a combination of person-centered and more traditional variable-centered approaches, we identified patterns of interrelated behaviors that differed on school, and nonschool days. Findings can inform targeted intervention strategies tailored to children’s specific behavior patterns.     

Associations of insomnia symptoms with subsequent health services use among community-dwelling U.S. older adults

Study ObjectivesDetermine the association of insomnia symptoms with subsequent health services use, in a representative sample of U.S. older adults.MethodsParticipants were 4,289 community-dwelling Medicare beneficiaries who had continuous fee-for-service Medicare coverage 30 days before, and 1 year after the National Health and Aging Trends Study (NHATS) Round 1 interview. Participants reported past-month insomnia symptoms (i.e. sleep onset latency >30 min, difficulty returning to sleep) which we categorized as 0, 1, or 2 symptoms. Outcomes were health services use within 1 year of interviews from linked Medicare claims: emergency department (ED) visits, hospitalizations, 30-day readmissions, home health care (all measured as yes/no), and number of hospitalizations and ED visits.ResultsOverall, 18.5% of participants were hospitalized, 28.7% visited the ED, 2.5% had a 30-day readmission, and 11.3% used home health care. After adjustment for demographics, depressive and anxiety symptoms, medical comorbidities, and BMI, compared to participants with no insomnia symptoms, those with two insomnia symptoms had a higher odds of ED visits (odds ratio [OR) = 1.60, 95% confidence interval [CI] = 1.24–2.07, p < 0.001), hospitalizations (OR = 1.29, 95% CI = 1.01–1.65, p < 0.05), and 30-day readmissions (OR = 1.88, 95% CI = 1.88–3.29, p < 0.05). Reporting 2 insomnia symptoms, versus no insomnia symptoms, was associated with a greater number of ED visits and hospitalizations (incidence rate ratio (IRR) = 1.52, 95% CI = 1.23–1.87, p < 0.001; IRR = 1.21, 95% CI = 1.02–1.44, p < 0.05, respectively) after adjusting for demographic and health characteristics.ConclusionsAmong older adults, insomnia symptoms are associated with greater health services use, including emergency department use, hospitalization, and 30-day readmission. Targeting insomnia may lower health services use.     

The Mediating Effect of Insomnia on the Relationship between Panic Symptoms and Depression in Patients with Panic Disorder

BackgroundThis study aimed to determine if sleep disturbances may mediate the relationship between panic symptoms and depression in patients with panic disorder (PD).MethodsElectronic medical records were retrospectively reviewed for 110 consecutive patients with diagnosed PD in an outpatient clinic between October 2018 and December 2019. Measurements include the PD Severity Scale, Beck Depression Inventory-II (BDI-II) and Insomnia Severity Index (ISI). Statistical analyses were performed to assess any potential relationship between PD, insomnia and depression.ResultsOf the PD patients, 88 (80%) and 89 (80.9%) had comorbid depression (BDI-II ≥ 14) and insomnia (Korean version of the ISI ≥ 8), respectively. In a mediation model using insomnia as the mediating variable, the total effect of panic symptom severity on depression was significant (t = 7.23, P < 0.001). There were significant effects of panic symptoms on insomnia (t = 4.62, P < 0.001) and of insomnia on depression (t = 6.69, P < 0.001). The main effect of panic symptom severity on depression was also significant, after controlling for the effect of insomnia (t = 5.10, P < 0.001), suggesting partial mediation.ConclusionBoth depressive symptoms and insomnia are common in patients with PD and depression was partially mediated by insomnia in these patients. These results suggest that an intervention for insomnia in patients with PD might help prevent the development of depression.     

Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting

Objective/Background: Primary care is where many patients with insomnia first ask for professional help. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia. Although CBT-I’s efficacy is well established, its effectiveness in real-life primary care has seldom been investigated. We examined the effectiveness of CBT-I as routinely delivered in a Canadian primary care setting. Participants: The patients were 70 women and 11 men (mean age = 57.0 years, SD = 12.3); 83% had medical comorbidity. Methods: For the first 81 patients who took the six-session group program we compared initial and postprogram sleep diaries, sleep medication use, Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS), and visits to the family physician. Results: Sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and ISI scores improved significantly (p < .001). Mood ratings also improved (p < .001). Use of sleep medication decreased (p < .001). Effect sizes were medium to large. Eighty-eight percent of patients no longer had clinically significant insomnia (ISI score ≤ 14) by the last session; 61% showed at least “moderate” improvement (ISI score reduction > 7). Wait-list data from 42 patients showed minimal sleep and mood improvements with the passage of time. Number of visits to the family physician six months postprogram decreased, although not significantly (p = .108). Conclusions: The CBT-I program was associated with improvement on all sleep and mood measures. Effect sizes were similar to, or larger than, those found in randomized controlled trials, demonstrating the real-world effectiveness of CBT-I in an interdisciplinary primary care setting.     

Natural history of insomnia symptoms in the transition from childhood to adolescence: population rates,health disparities,and risk factors

Study ObjectivesTo determine the sociodemographic, behavioral, and clinical risk factors associated with the persistence, remission, and incidence of insomnia symptoms in the transition from childhood to adolescence.MethodsThe Penn State Child Cohort is a random, population-based sample of 700 children (5–12 years at baseline), of whom 421 were followed-up as adolescents (12–23 years at follow-up). Subjects underwent polysomnography, clinical history, physical exam, and parent- and self-reported scales at baseline and follow-up. Insomnia symptoms were defined as a parent- or self-report of difficulty falling and/or staying asleep.ResultsThe 421 subjects with baseline (Mage = 8.8 years) and follow-up (Mage = 17 years) data were 53.9% male and 21.9% racial/ethnic minorities. The persistence of childhood insomnia symptoms (CIS) was 56% (95% CI = 46.5–65.4), with only 30.3% (95% CI = 21.5–39.0) fully remitting. The incidence of adolescent insomnia symptoms was 31.1% (95% CI = 25.9–36.3). Female sex, racial/ethnic minority, and low socioeconomic status as well as psychiatric/behavioral or neurological disorders, obesity, smoking, and evening chronotype were associated with a higher persistence or incidence of insomnia symptoms.ConclusionsCIS are highly persistent, with full remission occurring in only a third of children in the transition to adolescence. Sex-, racial/ethnic-, and socioeconomic-related disparities in insomnia occur as early as childhood, while different mental/physical health and lifestyle/circadian risk factors play a key role in the chronicity of CIS versus their incidence in adolescence. CIS should not be expected to developmentally remit and should become a focus of integrated pediatric/behavioral health strategies.     

A pathogenic cycle between insomnia and cognitive arousal fuels perinatal depression: exploring the roles of nocturnal cognitive arousal and perinatal-focused rumination

Study ObjectivesDepression is among the most prevalent perinatal complications, yet modifiable risk factors remain elusive. Over half of perinatal women endorse clinical insomnia symptoms, which are etiologically implicated in depression in nonperinatal samples. Yet, prospective data on perinatal insomnia and depression are mixed. We sought to clarify temporal associations of insomnia and depression during peripartum, and to investigate cognitive arousal as a potential mechanism facilitating this relationship.MethodsSeventy pregnant women completed sociodemographic information and baseline sleep and mood symptoms between gestational weeks 25 and 30. Beginning at gestational week 30, participants completed 17 weekly online surveys assessing insomnia, depression, and three cognitive arousal indices (nocturnal cognitive arousal, perseverative thinking, and perinatal-focused rumination). Mixed effects models were conducted to test hypotheses.ResultsWomen were at risk for depression when experiencing insomnia (odds ratio [OR] = 2.36, 95% confidence interval [CI] = 1.28 to 4.35), nocturnal cognitive arousal (OR = 3.05, 95% CI = 1.60 to 5.79), perinatal-focused rumination (OR = 2.05, 95% CI = 1.11 to 3.79), and perseverative thinking (OR = 7.48, 95% CI = 3.90 to 14.32). Prospective analyses revealed bidirectional effects between insomnia and cognitive arousal, and both predicted future depression. Nocturnal cognitive arousal mediated 23–43% of the effect of insomnia on depression. Insomnia mediated 12%–18% of the effect of nocturnal cognitive arousal on depression. A similar pattern was observed with perinatal-focused rumination. Depression did not predict insomnia.ConclusionNocturnal cognitive arousal, including ruminating on perinatal concerns while trying to fall asleep, fuels insomnia. In turn, lying awake at night provides an opportunity for nocturnal cognitive arousal. This cycle feeds perinatal depression. Daytime cognitive arousal may indirectly disrupt sleep as perseverating during the day persists into the night.     

Effects of Dietary Self-Monitoring,Physical Activity,Liraglutide 3.0 mg,and Placebo on Weight Loss in the SCALE IBT Trial

IntroductionIndividuals who enroll in intensive behavioral therapy (IBT) programs are asked to make several lifestyle changes simultaneously. However, few studies have examined the relative effects of adherence to different treatment components on weight loss.ObjectiveThis secondary analysis of the SCALE IBT trial assessed adherence to the medication regimen, dietary self-monitoring, and physical activity recommendations and their relative contributions to weight change in individuals with obesity who were provided with IBT combined with either liraglutide 3.0 mg or placebo.MethodsSCALE IBT was a double-blinded, multicenter, randomized controlled trial comparing 56-week weight losses in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140), as an adjunct to IBT. Adherence to dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo) were measured during the 56-week treatment period. A regression model was used to estimate the relative contribution of adherence to each treatment component to weight loss at week 56.ResultsThe proportion of individuals who adhered to each intervention component decreased over time. Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of −7.2% (95% CI −10.4 to −4.0; p < 0.0001) and −2.0% (95% CI −3.2 to −0.8; p = 0.0009), respectively. Complete adherence to liraglutide predicted an additional weight loss of −6.5% (95% CI −10.2 to −2.9; p = 0.0005) relative to individuals who did not adhere to the medication regimen, while adherence to placebo did not have a statistically significant effect on weight loss (p = 0.33).ConclusionsHigh adherence to dietary self-monitoring and use of liraglutide 3.0 mg was associated with clinically relevant weight loss with IBT and adjunctive pharmacotherapy. The effect of adherence to physical activity was significant but smaller.     

Prevalence of insomnia and anxiety among healthcare workers during the COVID-19 pandemic in Jilin Province

The outbreak of the 2019 novel coronavirus disease (COVID-19) has impacted the mental health of healthcare providers at the frontline. Therefore, we conducted this study to estimate the prevalence rate of anxiety and insomnia and identify associated risk factors among healthcare workers in Jilin, China, during the period from January 25 to February 25, 2020. Zung''s Self-Reported Anxiety Scale (SAS) and the Insomnia Severity Index (ISI) scale were used to diagnose anxiety and insomnia, respectively. Associated risk factors were identified through a multivariate logistic regression model. A total of 300 healthcare workers were invited and 236 completed the study. Of them, 234 (99.15%) were medical workers, 197 (83.47%) were working at frontline departments, and 159 (67.37%) were fighting against COVID-19. Fifty-seven respondents (24.15%) had anxiety (SAS index score ≥45) and 94 (39.83%) had insomnia (ISI score ≥8). Based on the multivariate analysis, contact with people from Hubei province during work (no vs not clear) [OR=0.25, 95%CI: 0.10-0.61] and personal protective equipment (PPE) (not in place vs in place) [OR=6.22, 95%CI: 2.23-17.40] were significantly correlated with anxiety. PPE (not in place vs in place) was the only significant risk factor of insomnia [OR=10.56, 95%CI: 4.00-27.87]. The prevalence of anxiety and insomnia was high in our study, reflecting the psychological impact of COVID-19 on healthcare workers. The unavailability of PPE in place was a significant risk factor of both anxiety and insomnia.     

Effect of trataka (yogic gazing) on insomnia severity and quality of sleep in people with insomnia

IntroductionInsomnia or sleeplessness is a common disorder associated with morbidity and poor quality of life. Trataka is one of the six cleansing techniques of yoga. Literature suggests that trataka could help in relieving insomnia. A study was conducted to evaluate the effect of trataka on insomnia severity and quality of sleep (QoS) in people with insomnia.Materials and MethodsTwenty-nine participants with insomnia were recruited, who underwent trataka (45 minutes per day daily) for a period of 10 days. Insomnia severity and QoS were assessed before and after the intervention using the Insomnia Severity Index (ISI) and The Pittsburgh Sleep Quality Index (PSQI), respectively.ResultsThis study showed a significant reduction in ISI score and PSQI global score and its associated subscale scores except sleep medication scores after the intervention.ConclusionTrataka may be considered as a treatment modality in reducing insomnia severity and in improving QoS in people with insomnia.