Baseline Insomnia Research Articles

A randomized controlled trial to evaluate the efficacy of electrical vestibular nerve stimulation (VeNS), compared to a sham control for the management of sleep in young adults.

Preliminary research suggests that electrical vestibular nerve stimulation (VeNS) may improve sleep outcomes by influencing the hypothalamus and brainstem nuclei involved in regulating the circadian rhythm and wakefulness. This randomised, sham-controlled trial aimed to assess the effectiveness of VeNS on insomnia in young adults. Eighty adults aged 18-24 years were randomly allocated to the intervention (n=40) and control groups (n=40). The intervention group was provided with 30min per day of VeNS with five sessions weekly for four weeks, while the control group received sham stimulation for the same period. Baseline Insomnia Sleep Index (ISI) scores were recorded weekly. At baseline and at day 28, questionnaires to evaluate emotional states of depression, anxiety and stress, and quality of life (QoL) were completed. The primary outcome was change in ISI with comparison between baseline and day 28. The VeNS group significantly reduced their mean ISI score after 7days usage (p<0.001). At day 28 it was found that mean ISI scores had reduced from 19 to 11 in the VeNS group, and from 19 to 18 in the sham group, and the difference between the groups was significant (p<0.001). Moreover, application of VeNS appeared to significantly improve emotional state and QoL outcomes. This trial demonstrates that regular VeNS usage over four weeks leads to a clinically meaningful decrease in ISI scores in young adults with insomnia. VeNS may have potential as a drug-free and non-invasive therapy to improve sleep outcomes by positively influencing the hypothalamic and brainstem nuclei.

EHealth-Based Psychosocial Interventions for Adults With Insomnia: Systematic Review and Meta-analysis of Randomized Controlled Trials.

Worldwide, insomnia remains a highly prevalent public health problem. eHealth presents a novel opportunity to deliver effective, accessible, and affordable insomnia treatments on a population-wide scale. However, there is no quantitative integration of evidence regarding the effectiveness of eHealth-based psychosocial interventions on insomnia. We aimed to evaluate the effectiveness of eHealth-based psychosocial interventions for insomnia and investigate the influence of specific study characteristics and intervention features on these effects. We searched PubMed, Embase, Web of Science, PsycINFO, and the Cochrane Central Register of Controlled Trials from database inception to February 16, 2021, for publications investigating eHealth-based psychosocial interventions targeting insomnia and updated the search of PubMed to December 6, 2021. We also screened gray literature for unpublished data. Eligible studies were randomized controlled trials of eHealth-based psychosocial interventions targeting adults with insomnia. Random-effects meta-analysis models were used to assess primary and secondary outcomes. Primary outcomes were insomnia severity and sleep quality. Meta-analyses were performed by pooling the effects of eHealth-based psychosocial interventions on insomnia compared with inactive and in-person conditions. We performed subgroup analyses and metaregressions to explore specific factors that affected the effectiveness. Secondary outcomes included sleep diary parameters and mental health-related outcomes. Of the 19,980 identified records, 37 randomized controlled trials (13,227 participants) were included. eHealth-based psychosocial interventions significantly reduced insomnia severity (Hedges g=-1.01, 95% CI -1.12 to -0.89; P<.001) and improved sleep quality (Hedges g=-0.58, 95% CI -0.75 to -0.41; P<.001) compared with inactive control conditions, with no evidence of publication bias. We found no significant difference compared with in-person treatment in alleviating insomnia severity (Hedges g=0.41, 95% CI -0.02 to 0.85; P=.06) and a significant advantage for in-person treatment in enhancing sleep quality (Hedges g=0.56, 95% CI 0.24-0.88; P<.001). eHealth-based psychosocial interventions had significantly larger effects (P=.01) on alleviating insomnia severity in clinical samples than in subclinical samples. eHealth-based psychosocial interventions that incorporated guidance from trained therapists had a significantly greater effect on insomnia severity (P=.05) and sleep quality (P=.02) than those with guidance from animated therapists or no guidance. Higher baseline insomnia severity and longer intervention duration were associated with a larger reduction in insomnia severity (P=.004). eHealth-based psychosocial interventions significantly improved each secondary outcome. eHealth interventions for insomnia are effective in improving sleep and mental health and can be considered a promising treatment for insomnia. Our findings support the wider dissemination of eHealth interventions and their further promotion in a stepped-care model. Offering blended care could improve treatment effectiveness. Future research needs to elucidate which specific intervention components are most important to achieve intervention effectiveness. Blended eHealth interventions may be tailored to benefit people with low socioeconomic status, limited access to health care, or lack of eHealth literacy.

Sleep and mental health in recruit paramedics: A 6-month longitudinal study.

To explore potential relationships and longitudinal changes in sleep and mental health in recruit paramedics over the first 6-months of work, and whether sleep disturbances pre-emergency work predict future mental health outcomes. Participants (N=101, 52% female, Mage=26 years) completed questionnaires prior to (baseline), and after 6 months of emergency work to assess for symptoms of insomnia, obstructive sleep apnea, post-traumatic stress disorder (PTSD), depression, anxiety, and trauma exposure. At each timepoint, participants also completed a sleep diary and wore an actigraph for 14 days to assess sleep patterns. Correlations between baseline sleep and mental health were conducted and changes in these variables across timepoints were examined using linear mixed models. Hierarchical regressions assessed whether sleep at baseline predicted mental health at follow-up. Insomnia and depression symptoms, and total sleep time increased while sleep onset latency decreased across the first 6 months of emergency work. Participants experienced an average of 1 potentially traumatic event during the 6-month period. Baseline insomnia predicted increased depression symptoms at the 6-month follow-up, while baseline wake after sleep onset predicted follow-up PTSD symptoms. Results highlight an increase in insomnia and depression across the initial months of emergency work, while sleep disturbances before emergency work were identified as potential risk factors for the development of depression and PTSD among paramedics in their early career. Screening and early interventions targeting poor sleep at the beginning of emergency employment may assist in reducing the risk of future mental health outcomes in this high-risk occupation.

The role of baseline insomnia in moderating the hypnotic properties of quetiapine

IntroductionThe primary aim of this study was to investigate the effect of quetiapine on insomnia and alcohol craving (craving) in subjects with co-occurring insomnia and AUD. MethodsInsomnia was assessed with the Insomnia Severity Index (ISI) and craving with the Penn Alcohol Craving Scale (PACS, primary) and Obsessive-Compulsive Drinking Scale (OCDS, secondary). A multivariable model adjusted for covariates (N = 123) evaluated the relationship between craving (PACS and OCDS total scores) and insomnia (ISI total score). To simultaneously assess the effects of treatment arm allocation and insomnia status, subjects (N = 115) were stratified into 4 groups, quetiapine-insomnia(N = 38), quetiapine-No insomnia(N = 19), placebo-insomnia(N = 38), and placebo-No insomnia(N = 20). Linear mixed-effects regression models adjusted for covariates compared the trajectories of ISI, PACS, and OCDS total scores across 12 weeks of treatment and at post-treatment follow-up at week 24, between the four groups. ResultsThe ISI total score was positively associated with the PACS (p = 0.006) and OCDS (p = 0.001) total scores in the multivariable models. In the longitudinal analysis, when compared to the three other groups, subjects with insomnia treated with quetiapine showed a marked reduction in their insomnia scores with a return of insomnia after stopping treatment. There was no significant difference between the groups for the PACS and OCDS total score trajectories. DiscussionAlthough craving is associated with insomnia, treatment with quetiapine may improve insomnia but not craving in patients with co-occurring AUD and insomnia.

Patterns of sleep disturbances across stages of cognitive decline.

The purpose of this study was to investigate insomnia symptoms and excessive sleep/sluggishness across stages of cognitive decline (cognitively normal [CN], Cognitively Impairment, Not Demented [CIND], dementia) in a large, racially/ethnically diverse sample of older adults (70+) in the US. We also examined whether sleep disturbances at baseline predicted conversion to CIND or dementia at follow-up. In this secondary analysis of the Aging, Demographics, and Memory Study (ADAMS) supplement of the Health Retirement Study, we analyzed patterns of informant-reported insomnia and excessive sleep symptoms among three groups of older adults (n=846): CN, CIND, and dementia. CIND adults were significantly more likely to have informant-reported insomnia symptoms than those in the CN group (p=0.013). This was driven by a significant race/ethnicity-by-insomnia interaction with diagnostic status (p=0.029), such that CIND Black and Hispanic older adults had increased insomnia symptom rates compared to CN, whereas White adults had similar insomnia symptoms across diagnostic status. Across all racial/ethnic groups, the prevalence of excessive sleep symptoms increased stepwise from CN to CIND to dementia (p<0.001). Overall, insomnia symptoms at baseline predicted conversion from CN to CIND (p<0.001, OR=0.288; 95% CI: 0.143-0.580) at 4-year (approximate) follow-up; there was no relationship between baseline insomnia or excessive sleep/sluggishness symptoms and conversion from CIND to dementia. This study provides evidence for the increased risk of insomnia symptoms among Hispanic and Black older adults with CIND, and indicates that insomnia symptoms may be associated with increased risk for development of cognitive impairment.

Agreement between actigraphy and sleep diaries: A 28-day real-time monitoring study among suicidal adolescents following acute psychiatric care

ObjectiveTo examine the agreement between, and adherence to, wrist actigraphy and digital sleep diaries as methods for sleep assessment among high-risk adolescents in the 28 days following discharge from acute psychiatric care. Sleep parameters included: number of nighttime awakenings (NWAK), sleep efficiency (SE), sleep onset latency (SOL), total sleep time (TST), and wake after sleep onset (WASO). MethodsFifty-three adolescents (12–18 years) were recruited following discharge from acute psychiatric care for suicide risk. Adolescents completed a baseline assessment followed by a 28-day monitoring period with daily sleep diaries and continuous wrist actigraphy. Bland-Altman and multi-level models examined agreement. ResultsAdherence to actigraphy was high, but lower for sleep diaries; a similar pattern of adherence emerged on weekdays vs. weekends. Bland-Altman analyses revealed no clinically meaningful bias for sleep parameters (except NWAK), but the limits of agreement make interpretation ambiguous. Our base model indicated strong agreement between actigraphy and sleep diaries for TST (r = 0.850), moderate for SOL (r = 0.325) and SE (r = 0.322), and weak for WASO (r = −0.049) and NWAK (r = 0.114). A similar pattern emerged with the insomnia severity models with baseline insomnia influencing agreement on all parameters. There were significant weekday-weekend differences for WASO and NWAK, but not for SOL, SE, and TST. ConclusionResults suggest that it may be beneficial to find a modeling approach to account for the concordant and discordant information and relevant time-level variables.

PSUN201 Efficacy and Safety of Lemborexant in Diabetic Patients With Insomnia Disorder

Abstract Background Patients with diabetes report sleep problems more often than healthy individuals. Notably, ∼50% of the patients with Type 2 diabetes have reported insomnia. However, literature on the efficacy and safety of commonly prescribed sleep promoting drugs in this patient group is limited. Lemborexant (LEM) is a dual orexin receptor antagonist approved in multiple countries for the treatment of adults with insomnia. In Study 303 (NCT02952820), LEM provided significant benefit on subject-reported sleep measures versus placebo (PBO). This analysis evaluated sleep diary-based efficacy and safety of LEM over 12mo in the subgroup of participants with diabetes. Methods Study 303 was a 12mo randomized, double-blind, PBO-controlled (first 6mo [Period 1]), phase 3 study in participants ≥18y with insomnia disorder and baseline Insomnia Severity Index total score ≥15. Patients with diabetes Type 1 or Type 2, identified by concomitant medications, were allowed to participate as long as their condition was considered stable and likely to be so during the year of treatment. During Period 1, participants received LEM 5mg (LEM5), LEM 10mg (LEM10), or PBO. During Period 2 (second 6mo), LEM participants continued their assigned dose and PBO participants were rerandomized to LEM5 or LEM10. Outcome measures included patient-reported (subjective [s]) sleep onset latency (sSOL), wake after sleep onset (sWASO), sleep efficiency (sSE), and total sleep time (sTST). Treatment-emergent adverse events (TEAEs) were assessed. Results The diabetic subgroup included 72/949 participants (Period 1: PBO, n=24; LEM5, n=26; LEM10, n=22). The majority of the participants were White (56/72 [77.8%]) and female (51/72 [70.8%]); 8/72 [11.1%] were Asian and 7/72 [9.7%] were Black. Mean age for PBO, LEM5 and LEM10 was 63.8y, 60.2y and 63.5y, respectively. The most common concomitant medication classes taken by participants were alimentary tract and metabolism. Overall, sleep-related outcomes at 6mo in participants with diabetes were consistent with the full study population. sSOL change from baseline (median) at 6mo was -10.77, -20.71, and -30.71 minutes for PBO, LEM5 and LEM10, respectively. Mean (SD) change from baseline at 6mo was for sWASO: PBO, -32.16 [36.93], LEM5, -43.80 [57.27], and LEM10, -57.55 [65.16]; for sSE: PBO, 8.06 [8.41]; LEM5, 13.20 [10.66], and LEM10, 18.08 [15.76]; and for sTST: PBO, 47.36 [59.76]; LEM5, 73.35 [56.0]; and LEM10, 86.32 [76.49]. Most TEAEs were mild or moderate and consistent with the known safety profile of LEM. The most common TEAE was somnolence reported in 4.2, 3.8, 13.6% for PBO, LEM5 and LEM10, respectively. Conclusions Long-term treatment with lemborexant appears effective in improving sleep onset and sleep maintenance variables in diabetic patients with insomnia, consistent with the overall study population. Furthermore, LEM was well-tolerated, and no new safety signals were observed in participants with diabetes, supporting LEM as a potential treatment option. Support: Eisai Inc. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Testing the Pragmatic Effectiveness of a Consumer-Based Mindfulness Mobile App in the Workplace: Randomized Controlled Trial.

BackgroundMental health and sleep problems are prevalent in the workforce, corresponding to costly impairment in productivity and increased health care use. Digital mindfulness interventions are efficacious in improving sleep and mental health in the workplace; however, evidence supporting their pragmatic utility, potential for improving productivity, and ability to reduce employer costs is limited.ObjectiveThis pragmatic, cluster randomized controlled trial aimed to evaluate the experimental effects of implementing a commercially available mindfulness app—Calm—in employees of a large, multisite employer in the United States. Outcomes included mental health (depression, anxiety, and stress), sleep (insomnia and daytime sleepiness), resilience, productivity impairment (absenteeism, presenteeism, overall work impairment, and non–work activity impairment), and health care use (medical visit frequency).MethodsEmployees were randomized at the work site to receive either the Calm app intervention or waitlist control. Participants in the Calm intervention group were instructed to use the Calm app for 10 minutes per day for 8 weeks; individuals with elevated baseline insomnia symptoms could opt-in to 6 weeks of sleep coaching. All outcomes were assessed every 2 weeks, with the exception of medical visits (weeks 4 and 8 only). Effects of the Calm intervention on outcomes were evaluated via mixed effects modeling, controlling for relevant baseline characteristics, with fixed effects of the intervention on outcomes assessed at weeks 2, 4, 6, and 8. Models were analyzed via complete-case and intent-to-treat analyses.ResultsA total of 1029 employees enrolled (n=585 in the Calm intervention group, including 101 who opted-in to sleep coaching, and n=444 in waitlist control). Of them, 192 (n=88 for the Calm intervention group and n=104 for waitlist) completed all 5 assessments. In the complete-case analysis at week 8, employees at sites randomized to the Calm intervention group experienced significant improvements in depression (P=.02), anxiety (P=.01), stress (P<.001), insomnia (P<.001), sleepiness (P<.001), resilience (P=.02), presenteeism (P=.01), overall work impairment (P=.004), and nonwork impairment (P<.001), and reduced medical care visit frequency (P<.001) and productivity impairment costs (P=.01), relative to the waitlist control. In the intent-to-treat analysis at week 8, significant benefits of the intervention were observed for depression (P=.046), anxiety (P=.01), insomnia (P<.001), sleepiness (P<.001), nonwork impairment (P=.04), and medical visit frequency (P<.001).ConclusionsThe results suggest that the Calm app is an effective workplace intervention for improving mental health, sleep, resilience, and productivity and for reducing medical visits and costs owing to work impairment. Future studies should identify optimal implementation strategies that maximize employee uptake and large-scale implementation success across diverse, geographically dispersed employers.Trial RegistrationClinicalTrials.gov NCT05120310; https://clinicaltrials.gov/ct2/show/NCT05120310

A Social Media Outage Was Associated with a Surge in Nomophobia, and the Magnitude of Change in Nomophobia during the Outage Was Associated with Baseline Insomnia.

We examined the immediate impact of a social media outage on nomophobia and associated symptoms using a longitudinal cohort design. Data were collected at two timepoints, baseline (T1) and during the social media outage of 4 October 2021 (T2). T1 was collected in August–September 2021 as part of the baseline of an ongoing study. The nomophobia questionnaire (NMP-Q), Generalized Anxiety Disorder-7 scale (GAD-7), and Athens insomnia scale (AIS) were administered to 2706 healthy participants from the general Bahraini population (56% females, mean age 33.57 ± 11.65 years). Approximately one month later, during the social media outage, 306 of the study participants were opportunistically assessed using the NMP-Q. At baseline, we found that nomophobia levels strongly correlated positively with both insomnia (p = 0.001) and anxiety symptoms (p = 0.001). This is the first report to examine the impact of a social media outage on nomophobia. Our findings indicate that symptoms of nomophobia increased significantly during a social media outage. Baseline insomnia scores predicted a surge in the global scores of nomophobia symptoms during a social media outage.

0775 Impact of insomnia, depression and anxiety on adherence to upper airway stimulation for obstructive sleep apnea: ADHERE registry update

Abstract Introduction Insomnia, depression and anxiety are common comorbid conditions in patients with obstructive sleep apnea (OSA) and can negatively impact positive airway pressure (PAP) therapy adherence. Subsequent intolerance to PAP may lead to surgical treatment such as upper airway stimulation (UAS). We sought to determine the impact of baseline insomnia, anxiety or depression on UAS therapy adherence using data from a large multi-center registry. Methods The ADHERE registry collects information on patients undergoing UAS (Inspire Medical, Golden Valley, MN) including baseline history of insomnia, depression, anxiety and the Insomnia Severity Index (ISI) questionnaire. We determined overall prevalence of insomnia, depression and/or anxiety, as well as UAS adherence after 6 months of therapy in groups with insomnia, depression, anxiety or none of these conditions. Using ISI to quantify insomnia, adherence in patients with no/mild insomnia (ISI &amp;lt; 15) was compared to those with moderate/severe insomnia (ISI ≥ 15). Results 1639 patients were included; 10% reported a history of insomnia, 23% depression and 16% anxiety. There was no difference in UAS adherence between groups with or without a history of insomnia, depression, or anxiety. A baseline ISI score was available in 470 patients with no history of insomnia, and in 81 patients with a history of insomnia. In patients with no history of insomnia, 59% had ISI scores ≥15, while in those with a history of insomnia, 85% had ISI scores ≥15 (p &amp;lt; 0.001). There was no difference in therapy usage between patients with ISI scores &amp;lt;15 and ≥15 (6.7 ± 2.2 hours/night versus 6.4 ± 2.5 hours/night, p = 0.5). Conclusion This study examined the impact of insomnia, depression or anxiety on adherence to UAS therapy for OSA. Patients with and without these conditions had similar UAS adherence. We found that insomnia as objectively based on the ISI score may be underdiagnosed in UAS patients who have no subjective history of insomnia at baseline. Despite this, ISI severity did not impact UAS adherence. Longer term follow-up with serial ISI scores and adherence data is needed to further understand how insomnia severity impacts UAS therapy outcomes and usage. Support (If Any)

0045 Examining the Association of Trait Sleep Reactivity with Changes in Sleep, Depression, and Anxiety in the COVID-19 Pandemic

IntroductionSleep Reactivity (SR), a trait-like tendency for stressful events to trigger sleep disturbances, is an established diathesis for insomnia and depression. However, no studies to date have examined SR in the context of the COVID-19 pandemic and it’s related restrictions. Thus, the goal of this analysis is to test whether SR confers a vulnerability for greater sleep and mood symptoms due to the stress of COVID-19 and it’s related restrictions. We hypothesized that (1) The onset of the pandemic will trigger greater increases in insomnia symptoms in highly sleep reactive individuals. 2) Sleep-reactive individuals would experience reduced recovery of insomnia, anxiety, and depression symptoms over the course of the pandemic.MethodsSR, insomnia, anxiety, and depressive symptoms were assessed by the Ford Insomnia Response to Stress Test (FIRST), Insomnia Severity Index (ISI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI II), respectively, at two time points (early-pandemic, 6-month follow-up). Additionally, participants retrospectively reported ISI prior to the pandemic. N = 253 adults from Stanford’s COVID-19 Pandemic Sleep Study (April-November 2020) provided baseline insomnia measures, and were excluded if they reported pre-pandemic clinical insomnia (ISI >10). Ranked-correlation tests were used to test the current hypotheses. Paired t-tests were used to evaluate changes in mean insomnia, depression, and anxiety scores. Covariates included essential worker status, sex, and age.ResultsISI after COVID-19 was significantly higher than retrospective, pre-pandemic ISI (t = 8.2, d = 0.55, p < 0.0001). However, SR was not significantly correlated with the pandemic-related increase in ISI (ρ = 0.07, p = 0.34). Depression significantly increased after 6-months (t = 2.0, d = 0.27, p = 0.047), whereas anxiety did not (t = 1.7, d = 0.26, p = 0.10). Neither changes in depression nor anxiety were predicted by SR (Depression: ρ = 0.15, p = 0.32; Anxiety: ρ = -0.13, p = 0.40).ConclusionInsomnia and depression, but not anxiety, increased with the onset of the pandemic. However, trait SR was not a predisposing factor for pandemic-related sleep and mood changes. This is the first analysis examining SR as a risk factor for insomnia and mood symptoms in the pandemic.Support (If Any)

Baseline Sleep Disturbances Modify Outcome Trajectories in Adolescents With Chronic Pain Receiving Internet-Delivered Psychological Treatment

Over 50% of adolescents with chronic pain report comorbid sleep disturbances (eg, difficulties with falling asleep), which is associated with increased pain-related disability and poorer quality of life. However, limited longitudinal data are available to understand how sleep disturbance may impact response to psychological treatment. Our primary hypothesis was that baseline sleep disturbances would significantly modify how adolescents responded to an internet-delivered psychological intervention for chronic pain in terms of outcome trajectories. The sample included 85 adolescents, 12 to 17 years, with chronic pain recruited from a multidisciplinary pain clinic and headache clinic who received access to an internet-delivered psychological intervention for chronic pain. Baseline sleep assessment included actigraphy monitoring for 7 days and survey measures. Outcomes were assessed at baseline, 8 weeks, and 3 months including core pain-related outcomes, executive functioning, fatigue, positive and negative affect. Results demonstrated that greater baseline insomnia and poorer sleep quality was associated with worse outcome trajectories for pain-related disability, depression, anxiety, fatigue, negative affect, and executive functioning. Findings extend the limited studies that examine how sleep disturbance may modify effectiveness of psychological treatments for adolescent chronic pain and emphasize the importance of treating comorbid sleep disturbance. This trial was registered at clinicaltrials.gov (NCT04043962). PerspectiveOur study suggests that sleep deficiency, in particular insomnia and poor sleep quality, may modify the effectiveness of psychological treatments for chronic pain, highlighting the urgent need to screen youth for sleep problems prior to initiating treatment, and to consider implementation of sleep-specific treatments such as cognitive-behavioral therapy for insomnia.

Relationship of overweight and obesity to insomnia severity, sleep quality, and insomnia improvement in a clinically referred pediatric sample.

Children with overweight or obesity are more likely to experience sleep disorders, although the role of weight in pediatric insomnia treatment has not been examined. The current study examined the relationships of high body mass with pretreatment insomnia severity and global sleep problems and the potential moderating impact of weight on changes in insomnia severity following insomnia treatment. Participants included 1,133 youth ages 2-18 years clinically referred for insomnia treatment. The Pediatric Insomnia Severity Index was collected at the initial assessment and throughout treatment as part of routine clinical care. Treatment status was coded as no treatment, early termination, and completed treatment. Secondary measures of global sleep problems at the initial assessment included the Adolescent Sleep Wake Scale, Adolescent Sleep Hygiene Scale, and Children's Sleep Habits Questionnaire. Medical chart review of visits within ± 3 months of baseline was used to obtain age-adjusted and sex-adjusted body mass index Z-score. Among adolescents, regression analyses found that higher body mass index Z-score modestly predicted baseline insomnia severity (P = .021) and worse sleep hygiene (P < .001). For children, higher body mass index Z-score was modestly associated with baseline total sleep problems (P = .006) but not insomnia severity (P = .792). Across ages, body mass index Z-score predicted neither treatment status nor insomnia improvement (P > .05). Findings were similar in categorical analyses comparing patients with overweight/obesity to healthy weight. Although there is evidence that children of higher body mass present for insomnia treatment with greater sleep concerns, body mass does not predict treatment completion or insomnia improvement. Data suggest insomnia treatment is effective irrespective of weight status. Duraccio KM, Simmons DM, Beebe DW, Byars KC. Relationship of overweight and obesity to insomnia severity, sleep quality, and insomnia improvement in a clinically referred pediatric sample. J Clin Sleep Med. 2022;18(4):1083-1091.

The Bidirectional Associations Between Insomnia and Psychotic-Like Experiences Before and During the COVID-19 Pandemic

Study ObjectivesPrevious literature supports that insomnia is predictive of subsequent psychotic-like experiences (PLEs) in the general population. However, there is a lack of empirical data on the reverse causality between the two variables and on the correlation between the symptom severity of insomnia and PLEs. This study aimed to explore the bidirectional associations between insomnia and PLEs before and during the COVID-19 pandemic.MethodsA total of 938 students aged 14–25 years completed both waves of the survey before and during the pandemic (the first wave: October 2019 to November 2019; the second wave: April 2020 to May 2020). PLEs were assessed using the 15-item positive subscale of the community assessment of psychic experiences (CAPE-P15), and insomnia was assessed using three questions on difficulty initiating sleep, difficulty maintaining sleep, and early morning awakening.ResultsStudents with baseline insomnia were more likely to exhibit new-onset PLEs during the pandemic (OR: 5.13, 95% CI: 2.54–10.38), while no significant predictive effect of insomnia was found for the persistence and severity of PLEs. Meanwhile, baseline PLEs not only predicted the presence of insomnia during the pandemic (OR: 2.14, 95% CI: 1.25–3.65) but also correlated with its severity (B: 0.89, 95% CI: 0.47–1.31).ConclusionThe study provides the first piece of evidence for the bidirectional association between insomnia and PLEs in the general population. However, although insomnia has an important predictive role in the occurrence of PLEs, it does not predict the persistence and development of PLEs, suggesting that there is a more complex mechanism underlying the process.

Worry and rumination predict insomnia in patients with coronary heart disease: a cross-sectional study with long-term follow-up.

Insomnia is highly prevalent and associated with anxiety and depression in patients with coronary heart disease patients. The development of effective psychological interventions is needed. Worry and rumination are potential risk factors for the maintenance of insomnia, anxiety, and depression that may be modified by psychological treatment grounded in the Self-Regulatory Executive Function model. However, the relationships between worry, rumination, anxiety and depression, and insomnia are not known. Therefore, we investigated these relationships both cross-sectionally and longitudinally among patients with coronary heart disease. A cross-sectional study consecutively included 1,082 patients in 2014-2015, and 686 were followed up after mean of 4.7 years. Data were gathered from hospital records and self-report questionnaires comprising assessment of worry (Penn State Worry Questionnaire), rumination (Ruminative Responses Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and insomnia (Bergen Insomnia Scale). Insomnia correlated moderately with all other psychological variables (R 0.18-0.50, all P values < .001). After adjustments for anxiety and depression, odds ratios for insomnia at baseline were 1.27 (95% confidence interval 1.08-1.50) and 1.60 (95% confidence interval 1.31-1.94) per 10 points increase of worry and rumination, respectively. Corresponding odds ratios for insomnia at follow-up were 1.28 (95% confidence interval 1.05-1.55) and 1.38 (95% confidence interval 1.09-1.75). Depression was no longer significantly associated with insomnia after adjustments for worry and rumination, but anxiety remained significant. Worry and rumination predicted insomnia both cross-sectionally and prospectively, even after controlling for anxiety and depression, although anxiety remained significant. Future studies may test psychological interventions targeting these factors in patients with coronary heart disease and insomnia. Frøjd LA, Papageorgiou C, Munkhaugen J, etal. Worry and rumination predict insomnia in patients with coronary heart disease: a cross-sectional study with long-term follow-up. J Clin Sleep Med. 2022;18(3):779-787.

Insomnia predicts treatment engagement and symptom change: a secondary analysis of a web-based CBT intervention for veterans with PTSD symptoms and hazardous alcohol use

Posttraumatic Stress Disorder (PTSD) and hazardous drinking are highly comorbid, and often more severe than PTSD or hazardous drinking alone. Integrated, web-based interventions for PTSD/hazardous drinking may increase access to care, but have demonstrated equivocal results in reducing PTSD and hazardous drinking. One factor that may explain treatment engagement and symptom change is the presence of insomnia symptoms. The current study conducted secondary data analysis of a randomized controlled trial of an integrated web-based intervention for PTSD symptoms and hazardous drinking to examine insomnia symptoms as predictors of PTSD symptoms, alcohol use, and treatment engagement. In the parent study, 162 veterans in primary care reporting PTSD symptoms and hazardous drinking were randomized to receive either the intervention or treatment as usual. The current study examined insomnia among veterans who received the intervention (n = 81). Regression models tested baseline insomnia symptoms as predictors of treatment engagement, follow-up PTSD symptoms, and alcohol use. Hierarchical regression models tested change in insomnia during treatment as a predictor of follow-up PTSD symptoms and alcohol use. Results showed baseline insomnia predicted treatment engagement and follow-up drinking days, but not PTSD symptoms or heavy drinking days. Although overall change in insomnia was small, it predicted follow-up PTSD and heavy drinking days, but not drinking days. Results are consistent with previous research highlighting the importance of identifying and treating insomnia in the course of integrated treatment for PTSD/hazardous drinking. Future research should investigate how to best integrate insomnia, PTSD, and/or hazardous drinking interventions to maximize treatment engagement.

Does Daylength Affect Sleep and Mental Health Symptoms during Behavioral Interventions for Insomnia?

ABSTRACT Background Approximately 11–33% of Australian adults experience Insomnia Disorder, which is associated with higher rates of psychiatric comorbidities, and lower quality of life. Non-pharmacological interventions are the front-line treatments for insomnia. Despite the known impact of light on the sleep/wake cycle via the circadian system, it is not yet known whether seasonal variations in environmental light levels (i.e., daylength) influence treatment outcome. We aimed to determine whether seasonal differences in daylength influenced baseline symptoms of Insomnia Disorder or treatment outcome. Participants One hundred treatment-seeking individuals with Insomnia Disorder (age: 49.3 ± 14.4y, range: 18–82 years; 58 F) enrolled in a Randomized Control Trial in Australia over a 29-month period. Methods Clients completed a seven-session behavioral intervention for insomnia over a maximum of 12 weeks. Individuals completed questionnaires assessing insomnia symptoms, diurnal preference, depression and anxiety symptoms, and daily sleep diaries. Objective rest/activity patterns were monitored using wrist actigraphy for the duration of the treatment period. Results Baseline daylength, sunset and sunrise times, and change in daylength over treatment, were not related to baseline insomnia severity or mental health symptoms. However, longer daylength at baseline predicted greater improvements in insomnia symptoms and anxiety, but not depression, symptoms. These improvements were also associated with later sunset and/or earlier sunrise at baseline. Conclusions Our results show, greater treatment-related improvements in subjective sleep and mental health symptoms during spring and summer months. This suggests that daylength could have a role to play in the outcomes of a behavioral insomnia treatment. Future research is needed to provide recommendations.

376 dCBT-I with Chatbot and Artificial Intelligence: a feasibility study in Brazil

Abstract Introduction Digital cognitive-behavioral therapies for insomnia (dCBT-I) provide low-cost, evidence-based technology, effective in improving mental health and reducing healthcare costs. However, dropout rates still challenge dCBT-I scalability. Moreover, few solutions are available in middle-and-low-income economies where they are most needed. Our goal was to investigate feasibility, describing real-world data and preliminary findings of a novel, fully automated program, developed by Vigilantes do Sono (Sleep Watchers) using Chatbot and Artificial Intelligence (AI). Methods A digital coach interacts with users daily for 5–10 minutes, asking them to complete tailored diaries and delivering CBT-I knowledge pills in ~50 sessions, during ~7 weeks. The Insomnia Severity Index (ISI) is used before and after sleep restriction cycles, weekly revised by an algorithm. Participants (18+ years) were recruited (Jan-Oct/2020) through advertisements on social media, organic search, or were referred by health-care professionals, without face-to-face evaluation. All electronically signed an informed consent. We estimated engagement dividing number of complete diaries by number of days in the program. Generalized Estimating Equations (GEE) evaluated changes in sleep parameters, adjusting for baseline characteristics. Results Of 3,887 individuals who completed initial assessment, 3,139 (81%) had insomnia (ISI ≥11) and 1,489 (42±11 years, 91% women) fulfilled 7+ diaries, commenced sleep restriction, and were included in analysis. Of them, 604 (41%) completed a second ISI and 326 (22%) finished the program. GEE analyzing 42,802 diaries showed sleep duration increased 16.8 (11.9–21.6) minutes from first to second week and 67.3 (52.8–81.8) after week seven; parallel to a relative increase of 34% in sleep efficiency among women and 26% among men. Of 296 participants who reached therapeutic response (ISI reduction ≥8), 66% completed all sessions and 34% crossed half-way. Insomnia remission (ISI≤7) was seen for 55% and 33% of those with subthreshold (n=171) or clinical (n=419) baseline insomnia, respectively. Median (interquartile) engagement was 86% (65–98) and 90% of users recommend the program. Conclusion Chatbot and AI provide a framework to customize dCBT-I and personalize insomnia therapy, potentially favoring engagement and effectiveness. Our findings demonstrate feasibility of the program and support moving forward to continued development and testing the effects in clinical trials. Support (if any):

359 Tailoring of Cognitive Behavior Therapy for Insomnia for Patients with Kidney Failure Undergoing Hemodialysis: The SLEEP-HD Study

Abstract Introduction Patients with kidney failure treated with hemodialysis (HD) frequently report insomnia symptoms. Cognitive-behavior therapy for insomnia (CBT-I) is a first line treatment for insomnia but there are unique issues surrounding kidney failure and HD that impact patients’ ability to access CBT-I and follow standard treatment recommendations. This presentation describes CBT-I protocol modifications made to address these issues as part of an ongoing multi-center clinical trial testing the efficacy of telehealth CBT-I compared to trazodone or medication placebo control. Methods CBT-I protocol modifications were made prior to starting the SLEEP-HD randomized trial based upon unique clinical considerations for HD patients, e.g., irregular sleep-wake scheduling that HD treatment demands, and napping during HD sessions or afterwards due to post-HD treatment fatigue. Participants in the SLEEP-HD study are undergoing thrice-weekly maintenance hemodialysis for &amp;gt;3 months and have baseline Insomnia Severity Index scores &amp;gt;10 with sleep disturbances &amp;gt;3 nights/week for &amp;gt;3 months. Participants randomized into the modified CBT-I protocol receive six weekly sessions, delivered by trained CBT-I therapists (1 MSW, 1 PhD) face-to-face via a HIPPA-compliant video telehealth platform. Participants keep a daily sleep diary throughout the CBT-I treatment period. Results To date, 91 patients (mean age=56.5 years [SD=14.7], 48.4% female) recruited from community-based dialysis facilities in Seattle and Albuquerque have been randomized into the SLEEP-HD study (n=31 CBT-I). Forty-eight percent of CBT-I clients have chosen to conduct their telehealth sessions during dialysis with the remainder choosing a different location. CBT-I adaptations include therapists developing weekly bed restriction recommendations based on non-dialysis treatment days; allowing shifts in dialysis day “bed window” scheduling for patients with very early or very late dialysis schedules so long as a consistent total time in bed in maintained; and including napping during early/late dialysis sessions as part of the allowable bed window duration. Treatment modifications were also designed to accommodate the diverse socioeconomic circumstances of dialysis patients, including housing instability, which can impact adherence to some standard stimulus control and bed restriction CBT-I recommendations. Conclusion It is feasible to deliver CBT-I via telehealth to HD patients but modifications to standard protocols are required. Support (if any) This work was supported by PHS grant 5R01AG053221.

355 Predictors of Longitudinal Sleep Outcomes in a Statewide Randomized Trial of Telephone Cognitive Behavioral Therapy for Insomnia

Abstract Introduction We examined the relationship between treatment process measures and 12-month insomnia outcomes from a large clinical trial of telephone-delivered CBT-I. Methods A statewide sample of 327 Kaiser Permanente Washington members aged 60+ with OA, Insomnia Severity Index (ISI) scores of 11+ and Brief Pain Inventory scores of 9+ were randomized to six sessions of individual telephone-delivered cognitive-behavior therapy for insomnia (CBT-I) vs. education-only control. Participants rated their perceptions of treatment credibility and perceived effectiveness on a 7-point Likert scale after session 1 and at 2-month post-test. They also completed the Sleep Hygiene Index (SHI), the 8-item Sleep Problem Acceptance Questionnaire (SPAQ), and the 8-item Chronic Pain Acceptance Questionnaire (CPAQ) at baseline, post-treatment, and 12 months. Insomnia outcome was measured using the ISI. Results Participants (mean age=70.2 years [SD=6.81], 74.6% female, 87.8% with sleep problems for over 1 year) were randomized to the two treatment arms. Regression analyses controlling for baseline age, opioid use, depression, pain, and ISI showed that lower 12-month ISI scores were associated with CBT-I group membership and lower baseline ISI (both p&amp;lt;.001), higher session 1 ratings of treatment credibility (p=.004), higher baseline CPAQ activity engagement (AE) subscale scores (p=.04), and lower baseline SPAQ AE scores (p=.016) when predictors were simultaneously entered. Lower 12-month ISI scores were also associated with post-test ratings of treatment perceived effectiveness (p=.004) and higher SPAQ AE (p=.038) scores. Improvements on the SHI at post-test were significantly associated with lower 12-month ISI scores when variables were entered singly into regression models, but not when all predictors were entered simultaneously. SPAQ and CPAQ sleep and pain willingness subscale scores were not significantly related to ISI outcomes in any model. Conclusion People with less severe baseline insomnia levels who received telephone-delivered CBT-I were more likely to have lower 12-month ISI scores. Participant perceptions of treatment credibility and effectiveness, and engagement in life activities despite pain and sleep symptoms were also associated with long-term improvements in insomnia, but willingness to experience sleep and pain symptoms were not contributing factors. Support (if any) This work was supported by PHS grant 5R01AG053221.