DSM-5 Insomnia Disorder Research Articles

Assessing insomnia after stroke: a diagnostic validation of the Sleep Condition Indicator in self-reported stroke survivors.

Insomnia is common after stroke and is associated with poorer recovery and greater risk of subsequent strokes. Yet, no insomnia measures have been validated in English-speaking individuals affected by stroke. This prospective diagnostic validation study investigated the discriminatory validity and optimal diagnostic cut-off of the Sleep Condition Indicator when screening for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) insomnia disorder post-stroke. A convenience sample of 180 (60.0% women, mean age=49.61 ± 12.41 years) community-based, adult (≥18 years) self-reported stroke survivors completed an online questionnaire. Diagnosis of DSM-5 insomnia disorder was based on analysis of a detailed sleep history questionnaire. Statistical analyses explored discriminant validity, convergent validity, relationships with demographic and mood variables, and internal consistency. Receiver operating characteristic curves were plotted to assess diagnostic accuracy. Data from the sleep history questionnaire suggested that 75 participants (41.67%) met criteria for DSM-5 insomnia disorder, 33 (18.33%) exhibited symptoms of insomnia but did not meet diagnostic criteria, and 72 (40.0%) had no insomnia symptoms at the time of assessment. The Sleep Condition Indicator (SCI) demonstrated 'excellent' diagnostic accuracy in the detection of insomnia post-stroke, with an area under the curve of 0.86 (95% CI (0.81, 0.91)). The optimal cut-off was determined as being ≤13, yielding a sensitivity of 88.0% and a specificity of 71.43%. The findings of this study demonstrate the SCI to be a valid and reliable method with which to diagnose DSM-5 insomnia disorder and symptoms post-stroke. However, a lower threshold than is used in the general population may be necessary after stroke.

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy

ObjectivesCognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal. MethodsA single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n = 5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale. ResultsEleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen's dz = 3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen's dz = 2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen's dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components. ConclusionPrenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression. Clinicaltrials.gov idNCT04443959.

0317 A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for prenatal insomnia

Abstract Introduction Cognitive behavioral therapy for insomnia (CBTI) improves sleep in pregnancy, but its therapeutic benefits may be diminished in pregnancy due to undertreatment of cognitive arousal (i.e., heightened cognitive activity, especially at night). Growing evidence indicates that mindfulness-based interventions produce large reductions in cognitive arousal, which may enhance insomnia therapy outcomes. The present study was a proof-of-concept, single-arm trial of Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness intervention framework and tailors sleep and mindfulness components to pregnancy. We evaluated patient engagement, treatment outcomes, and patient feedback from 12 pregnant women with insomnia who received PUMAS treatment. Methods Twelve pregnant women with DSM-5 insomnia disorder were treated with six weekly telemedicine sessions of PUMAS. Patient engagement was operationalized as session attendance. Treatment outcomes were assessed before and after PUMAS, which included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale’s cognitive factor (PSASC), and Glasgow sleep effort scale (GSES). Patients completed the Consumer’s report treatment satisfaction scale and provided treatment feedback. Results Eleven of 12 patients completed all six sessions (91.7%). Intent-to-treat analyses revealed very large reductions in ISI (ISI: 14.50±2.50 to 3.67±3.11; p<.001, Cohen’s dz=3.05), resulting in an 83.3% insomnia remission rate (n=10/12). Among the five patients with comorbid depression (EPDS≥10), PUMAS produced large antidepressant effects (EPDS: 14.00±3.32 to 5.00±2.55; p=.004, Cohen’s dz=2.76), and all five patients remitted from depression at posttreatment. PUMAS yielded very large reductions in cognitive arousal (PSASC: 20.75±4.58 to 12.50±4.23, p<.001, Cohen’s dz=2.08) and sleep effort (GSES: 5.92±2.64 to 2.08±1.62; p<.001, Cohen’s dz=2.06). Patients reported the highest rates of treatment satisfaction for improvement in insomnia (100%), energy (90.9%), pregnancy stress (90.9%), mood (90.9%), and coping with stress (83.3%). Patients identified sleep restriction and meditations as the most helpful PUMAS components. Conclusion Pregnant women with DSM-5 insomnia disorder are engaged in PUMAS, which produced large reductions in insomnia, depression, cognitive arousal, and sleep effort. Patients reported high satisfaction across several domains of functioning. This trial supports testing PUMAS in a randomized controlled trial. Support (if any)

0400 Examining the Effectiveness of Telehealth Delivered Cognitive Behavioral Treatment of Insomnia

Abstract Introduction Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective tool in improving symptoms of insomnia, however access is limited. One option for increasing access is the use of telehealth. We conducted a randomized trial comparing CBT-I delivered in-person to over video telehealth and found that telehealth treatment was non-inferior on self-reported insomnia severity. The objective of this study was to extend this analysis to secondary outcomes of subjective and objective measures of sleep as further assessment of the efficacy of telehealth compared to in-person treatment. Methods Individuals with DSM-5 insomnia disorder (n=60) were randomized to telehealth CBT-I, in person CBT-I, or 8-week waitlist control, although this analysis only compared the CBT-I groups. CBT-I was delivered over 6-8 weekly sessions by video telehealth or in-person in an outpatient clinic. Follow-up assessment was at 2 weeks post-treatment. Both objective and subjective outcomes of sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time (TST) were collected via actigraphy and sleep diaries. Random effects mixed models were used to determine the effects of group, treatment, and their interaction. Results The mean change in SE, SOL, WASO, and TST for objective measures from baseline to follow-up was 0.43% and -17.7 minutes, -6.8 minutes, -31.0 minutes, respectively, for in person CBT-I and 0.01%, -15.1 minutes, -2.1 minutes, -9.5 minutes, respectively, for telehealth. For subjective measures, the mean change was 0.16% and -27.0 minutes, -22.7 minutes, 28.9 minutes, respectively, for in person CBT-I and 0.15%, -23.4 minutes, -23.4 minutes, 51.6 minutes respectively for telehealth. The differences between the CBT-I groups were not statistically significant, nor were there significant interaction effects. Conclusion In both objective and subjective measures of insomnia, there is no evidence that outcomes from telehealth delivery of CBT-I is worse than in person treatment. Subjective effects were much larger than objective effects for insomnia possibly indicating a discrepancy between how sleep and more particularly insomnia is perceived by oneself and measured in the lab. Support (if any) This research was supported by grant 167-SR-17XYZ from the American Sleep Medicine Foundation and a Doris Duke Charitable Foundation Clinical Scientist Development Award.

What are patients completing Cognitive Behavioral Insomnia Therapy telling us with their post-treatment Insomnia Severity Index scores?

Study objectiveCognitive Behavioral Insomnia Therapy (CBT-I) is the gold standard insomnia treatment and the Insomnia Severity Index (ISI) is a frequently used treatment outcome measure. The ISI has strong psychometric properties and is purported to measure perceived insomnia symptom severity. However, little is known about the factors that drive insomnia severity perception and the psychometric properties of the ISI post-CBT-I. MethodsParticipants were treatment-seeking adults meeting DSM-5 Insomnia Disorder criteria (n = 203, ages 18–77, M = 45.95 years). Participants completed sleep and mood questionnaires, including the ISI, pre- and post-CBT-I. They completed daily Consensus Sleep Diaries each morning throughout two pre-treatment weeks, eight weeks of treatment and two weeks post-treatment. A hierarchical regression analysis examined what predicted post-CBT-I ISI scores and Cronbach's alpha was computed to examine post-treatment reliability of the ISI. ResultsThe regression analysis revealed that lower post-treatment ISI scores were associated with lower pre-treatment ISI, and greater decreases in fatigue and generalized anxiety symptoms. The model did not significantly improve when pre-treatment sleep effort or changes in sleep diary indices were added. The post-treatment ISI Cronbach's alpha was .88. ConclusionsAlthough the ISI has been shown to have sound psychometric properties, clinicians should consider that post CBT-I ISI scores are not related to their sleep improvements. Instead, they seem to be related to whether patients perceive themselves as poor sleepers pre-treatment and whether they felt less tired and anxious after CBT-I. Researchers should consider the impact of factors other than sleep when using the ISI at post-treatment. Patients are telling us that CBT-I should focus on addressing symptoms of fatigue and general anxiety; perhaps CBT-I could be improved further to address these concerns more effectively. SummaryThis investigation shows that when individuals are rating their symptom severity after CBT-I, they are also integrating how they felt before treatment and whether they experienced a change in their fatigue or anxiety.

A two-night polysomnography preliminary study in pregnant women with insomnia: suicidal ideation and nocturnal cognitive arousal prospectively predict objective nocturnal wakefulness.

Sleep disruption is common in pregnancy, manifesting as insomnia in half of pregnant women as well as increasing objective nocturnal wakefulness across gestation. Despite potential overlap between insomnia and objective sleep disturbances in pregnancy, objective nocturnal wakefulness and its potential contributing factors remain uncharacterized in prenatal insomnia. The present study described objective sleep disturbances in pregnant women with insomnia and identified insomnia-related predictors of objective nocturnal wakefulness. Eighteen pregnant women with clinically significant insomnia symptoms (n = 12/18 with DSM-5 insomnia disorder) underwent two overnight polysomnography (PSG) studies. Insomnia symptoms (Insomnia Severity Index), depression and suicidal ideation (Edinburgh Postnatal Depression Scale), and nocturnal cognitive arousal (Pre-Sleep Arousal Scale, Cognitive factor) were assessed before bedtime on each PSG night. Unique to Night 2, participants were awakened after 2 minutes of N2 sleep and reported their in-lab nocturnal (i.e. pre-sleep) cognitive arousal. Difficulty maintaining sleep was the most common objective sleep disturbance affecting 65%-67% of women across both nights, which contributed to short and inefficient sleep. Nocturnal cognitive arousal and suicidal ideation were the most robust predictors of objective nocturnal wakefulness. Preliminary evidence suggested nocturnal cognitive arousal mediates the effects of suicidal ideation and insomnia symptoms on objective nocturnal wakefulness. Nocturnal cognitive arousal may facilitate upstream effects of suicidal ideation and insomnia symptoms on objective nocturnal wakefulness. Insomnia therapeutics reducing nocturnal cognitive arousal may benefit objective sleep in pregnant women presenting with these symptoms.

Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program.

Combining mindfulness with behavioral sleep strategies has been found to alleviate symptoms of insomnia and depression during pregnancy, but mechanisms for this treatment approach remain unclear. The present study examined nocturnal cognitive arousal and sleep effort as potential treatment mechanisms for alleviating insomnia and depression via a mindfulness sleep program for pregnant women. Secondary analysis from a proof-of-concept trial of 12 pregnant women with DSM-5 insomnia disorder who were treated with Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness framework. Data were collected across eight weekly assessments: pretreatment, six sessions, and posttreatment. Measures included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC), and the Glasgow sleep effort scale (GSES). We used linear mixed modeling to test cognitive arousal and sleep effort as concurrent and prospective predictors of insomnia and depression. Most patients reported high cognitive arousal before PUMAS (75.0%), which decreased to 8.3% after treatment. All insomnia remitters reported low cognitive arousal after treatment, whereas half of nonremitters continued reporting high cognitive arousal. Both nocturnal cognitive arousal and sleep effort were associated with same-week changes in insomnia throughout treatment, and sleep effort yielded a prospective effect on insomnia. Lower levels of nocturnal cognitive arousal and sleep effort prospectively predicted reductions in depression. The present study offers preliminary evidence that reducing sleep effort and nocturnal cognitive arousal may serve as key mechanisms for alleviating insomnia and depression via mindfulness-based insomnia therapy. ClinicalTrials.gov ID: NCT04443959.

0473 The impact on treatment adherence of adding a bedpartner to CBT-I: preliminary findings from a randomised controlled trial (Project REST)

Abstract Introduction Cognitive Behavioural Therapy for Insomnia (CBT-I) includes often difficult-to-implement behavioural change, and this can result in poor adherence to treatment recommendations. In other CBTs, adding a significant other to “individual” therapy increases adherence. Here, we report preliminary findings from a randomised controlled trial (RCT) of a newly developed partner-assisted CBT-I. Methods 117 adults with DSM-5 Insomnia Disorder (age M±SD=47.9±15.3yrs; 73F) and their live-in partners participated in a single-blind parallel RCT. They were assigned 1:1:1 to 7wk individual CBT-I (Ind-CBTI), partner-assisted CBT-I (PA-CBTI), or sleep management control (CTRL) conditions. Participants completed daily sleep diary throughout the intervention. Adherence in CBT-I conditions was assessed for Sleep Restriction Therapy (deviation from bed and wake times, naps) and Stimulus Control Therapy (wake time-in-bed during daytime, overnight, and after final morning awakening). Intention-to-treat, mixed effects models examined differences in adherence for “Build” (initial phase to build sleep debt) and “Maintain” (starting the first week when sleep opportunity was titrated upwards) stages of therapy. Results All conditions showed significant increase in sleep efficiency (p<.001), with significantly faster increase in Ind-CBTI and PA-CBTI compared to CTRL (ps<.001). Sleep Restriction Therapy: Build stage (vs Maintain) had greater adherence to prescribed wake time (p=.045); Condition by Stage interaction (p=.010) showed PA-CBTI (vs Ind-CBTI) adhered better in avoiding naps during Build (vs Maintain). Stimulus Control Therapy: PA-CBTI (vs Ind-CBTI) adhered better to avoiding daytime wake time-in-bed (p=.017), especially during Build (interaction p=.071); Condition by Stage interaction (p=.017) showed PA-CBTI (vs Ind-CBTI) adhered better to avoiding overnight wake time-in-bed during Maintain (vs Build). Both conditions had better adherence to avoiding daytime and wake time-in-bed after final awakening during Maintain (vs Build) Stage (ps<.001). Conclusion Adherence to CBT-I includes multiple indicators showing distinct features as the intervention progresses across different stages. Aspects of adherence appear modifiable, and adding bedpartners to CBT-I improved adherence to specific aspects of the intervention (i.e., avoiding naps, daytime wake time-in-bed, overnight wake time-in-bed). The Build and Maintain stages of treatment appear to be associated with better adherence to different aspects of the intervention (Sleep Restriction Therapy and Stimulus Control Therapy, respectively). Support (If Any) NHMRC grant APP1105458 (SPAD,DHB,PJN), APP1140299 (BB)Trial registration: ACTRN12616000586415

0682 Cognitive-behavioral therapy for insomnia alleviates and prevents suicidal ideation

Abstract Introduction Patients with insomnia disorder are at increased risk for suicidal thoughts and behaviors. Early evidence suggests that insomnia therapeutics may reduce suicidal ideation (SI). However, the role of digital insomnia therapeutics in both the alleviation and prevention of SI remains unclear. Methods A total of 658 community adults with DSM-5 insomnia disorder enrolled into a single-site RCT evaluating the efficacy of digital cognitive behavioral therapy for insomnia (CBTI) relative to attention control. Before treatment, 126 patients endorsed SI, whereas 532 patients denied SI. First, we tested whether CBTI can reduce SI in patients with baseline SI. Second, we tested whether CBTI reduces risk for SI development in those without baseline SI. Results Among those with baseline SI, just 30.0% of CBTI patients reported SI after treatment, which was lower than the 54.5% of controls with posttreatment SI (OR=2.81, p=.006). Among those without baseline SI, CBTI did not reduce risk for developing SI after treatment (p=.681). However, a multivariate logit model regression odds for SI onto condition (p=.140) and posttreatment remission status (OR=5.68, p=.007) indicated that patients who remitted from insomnia exhibited a reduction in SI risk. Importantly, CBTI was associated with a 6.29 odds increase of insomnia remission relative to control. PRODCLIN estimation of the indirect effect indicated that CBTI prevents SI, but that the effect is fully mediated by the extent to which CBTI produces insomnia remission (αβ=-3.13=5, 95% CI=-5.28, -0.96). Conclusion Digital CBTI reduces risk for SI development in insomnia patients without pretreatment SI. These data support a role for digital insomnia therapeutics in SI prevention in this high-risk patient population. Moreover, digital CBTI reduces SI in insomnia patients with SI. These data indicate that digital CBTI can alleviate SI, but it possible that adjunct treatment directly targeting SI may enhance suicide risk reduction. Support (If Any) Robert Wood Johnson Foundation

DSM-5 insomnia disorder in pregnancy: associations with depression, suicidal ideation, and cognitive and somatic arousal, and identifying clinical cutoffs for detection.

Study ObjectivesThe study had three primary goals. First, we estimated survey-assessed DSM-5 insomnia disorder rates in pregnancy, and described associated sociodemographics, and sleep-wake and mental health symptoms. Second, we derived cutoffs for detecting DSM-5 insomnia disorder using common self-report measures of sleep symptoms. Third, we identified clinically relevant cut-points on measures of nocturnal cognitive and somatic arousal.MethodsNinety-nine women (85.9% in the 2nd trimester) completed online surveys including DSM-5 insomnia disorder criteria, the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Presleep Arousal Scale’s Cognitive (PSASC) and Somatic (PSASS) factors, and Edinburgh Postnatal Depression Scale.ResultsDSM-5 insomnia disorder rate was 19.2%. Insomnia was associated with depression, suicidality, nocturnal cognitive and somatic arousal, and daytime sleepiness. An ISI scoring method that aligns with DSM-5 criteria yielded excellent metrics for detecting insomnia disorder and good sleep. Regarding quantitative cutoffs, ISI ≥ 10 and ISI ≥ 11 (but not ISI ≥ 15) were supported for detecting DSM-5 insomnia, whereas ISI ≤ 7 and ISI ≤ 9 performed well for detecting good sleep. PSQI cutoff of 5 was supported for detecting insomnia and good sleep. The optimal cutoff for nocturnal cognitive arousal was PSASC ≥ 18, whereas the optimal cutoff for somatic arousal was PSASS ≥ 13.ConclusionsInsomnia disorder affects a large segment of pregnant women. Empirically derived cutoffs for insomnia, good sleep, cognitive arousal, and somatic arousal may inform case identification and future perinatal sleep research methodology.

346 Semi-Individualized Acupuncture for Insomnia Disorder: A Randomized Sham-Controlled Trial

Abstract Introduction Acupuncture is an alternative treatment for improving sleep quality and the effectiveness is thought to be optimized with an individualized approach resembling real practice. However, existing evidence is limited by methodological shortcomings due to blinding issues, standardized measures, and diagnostic procedures. It was of the present study’s interest to examine the efficacy and safety of semi-individualized acupuncture treatment on insomnia. Methods Adults with DSM-5 insomnia disorder (n = 140) were randomized with 1:1 allocation to a 4-week intervention traditional acupuncture (TA) or validated non-invasive sham acupuncture (SA). The selection of acupoints was semi-individualized by the acupuncturist. As the primary outcome, the sleep efficiency (SE) by sleep diary was assessed at baseline, 1-week posttreatment, and 5-week posttreatment. Other sleep parameters derived from sleep diary, the wrist-actigraphy-derived sleep parameters, insomnia symptom severity, anxiety, and depressive symptoms, as well as the health-related quality of life, were also evaluated. Results Although linear mixed-effect model revealed both groups did not attain significant difference in sleep-diary-derived SE and other outcome measures (all P > 0.05), TA promising effect on improving insomnia symptom (within-group effect size, d = 1.13 & 1.30 at 1-week & 5-week posttreatment respectively) and also a higher proportion of subjects achieved SE ≥ 85% compared with SA (55.6% versus 36.4% at week 9, P = 0.03). Besides, subjects in TA group reported significantly greater improvement in both the total sleep time (TST) derived from sleep diary and actigraph than those in the SA group at 1-week posttreatment (difference in mean changes from baseline: sleep diary = 22.0 min, p = 0.01; actigraphy =18.8 min, P = 0.02) but not 5-week posttreatment. Conclusion This study is the first to evaluate the effect of the TCM-theory-based individualized acupuncture on sleep using a sham-control design. A 4-week semi-individualized acupuncture is able to significantly increase total sleep time with few adverse events. Support (if any) Research Grants Council of Hong Kong, Early Career Scheme (Project no.: 25101017)

813 Patient and Provider Experiences with CBT-I Administered In-Person or via Telemedicine

IntroductionCBT-I is the gold standard treatment for insomnia, but access to in-person care is limited, which has worsened due to the recent COVID-19 pandemic. While providers across spheres of care have rapidly pivoted to telehealth there have been few systematic comparisons of in-person treatments to telemedicine approaches. The current study, launched pre-COVID, aimed to examine the perspectives of patients who were randomly assigned to receive CBT-I in-person or via telemedicine. Additionally, provider reflections were collected.MethodsIndividuals with DSM5 Insomnia Disorder (n=60) were randomized to in-person CBT-I, telemedicine CBT-I or a wait-list control group. CBT-I was delivered over 6–8 weekly sessions by video telemedicine or in-person. This nested qualitative study addressed patient and provider perspectives on treatment approaches. A sample of participants from each group (n=36) were interviewed 3 months post-treatment. Phone interviews were audio recorded, transcribed and analyzed using a directed content analysis approach. Results were organized into thematic categories including 1) participant experience with CBT-I, 2) access issues and 3) accountability issues related to delivery approach. Additionally, participating providers (n=7) were interviewed and shared their reflections on delivering CBT-I in-person vs. telemedicine.ResultsPatients reflected positively on CBT-I, and this did not vary across treatment groups. Patients and providers noted telemedicine benefits related to access that included, but were not limited to, reducing transportation barriers to treatment and improved continuity of care (e.g. not having to cancel an appointment if a patient was traveling). Patients and providers shared concerns they had anticipated pre-treatment about possible telemedicine related technological hurdles and barriers to establishing meaningful rapport on-line. However, they reported that these concerns did not prove to be barriers to effective telemedicine visits.ConclusionThis qualitative study allowed patients and their providers to reflect on their experience delivering in-person vs telemedicine CBT-I. CBT-I was accepted well regardless of delivery approach. Telemedicine is currently being deployed widely and this study provides a systematic comparison between approaches.Support (if any)This study was supported by the American Sleep Medicine Foundation.

Impact of Lemborexant on Fatigue Severity and Sleep Outcomes in Older Adults With Clinically Significant Fatigue at Baseline

<h3>Introduction</h3> In addition to sleep onset and/or maintenance difficulties, sleep-related daytime impairments must be acknowledged by patients to meet DSM-5 insomnia disorder diagnostic criteria. Daytime functioning impairments of insomnia disorder may include mood disturbances, decreased energy and fatigue. Given higher insomnia disorder prevalence and negative fatigue health and function impacts in older adults, treatment may require monitoring and managing sleep-related fatigue. Lemborexant (LEM) is a dual orexin receptor antagonist, approved in the US, Canada and Japan for the treatment of insomnia in adults. In the pivotal Phase 3 Study E2006-G000-303 (Study 303; SUNRISE-2; NCT02952820), LEM provided significant benefit on subjective sleep and fatigue severity outcomes vs placebo (PBO). In this post-hoc analysis, these outcomes were analyzed in subjects aged ≥65y with baseline Fatigue Severity Scale (FSS) total score ≥36 indicating clinically significant fatigue (analysis subgroup). <h3>Methods</h3> Study 303 was a 12-month, randomized, double-blind study in subjects aged ≥18y (n=949). For the first 6 months (Treatment Period 1), subjects received PBO or LEM (5mg [LEM5]; 10mg [LEM10]). During the second 6 months (Treatment Period 2), PBO subjects were rerandomized to LEM5 or LEM10 (reported separately) while LEM subjects remained on their original doses. The FSS is a self-report questionnaire that evaluates the impact of fatigue on quality of life and daily functioning. FSS total score (TS) ≥36 indicates clinically significant fatigue, and baseline FSS-TS ≥36 was used to select the analysis subgroup in subjects aged ≥65y. Changes from baseline in FSS-TS, subjective sleep onset latency (sSOL), subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO) for LEM vs PBO, assessed during Treatment Period 1 are presented. <h3>Results</h3> For the analysis subgroup (Total, n=134; PBO, n=41; LEM5, n=44; LEM10, n=49), mean FSS-TS (SD) at baseline was 44.1 (6.8), 46.2 (7.6), and 44.9 (6.3) in PBO, LEM5, and LEM10, respectively. At 6 months, mean (SD) decreases from baseline (improvement) in FSS-TS were significantly greater with LEM vs PBO (PBO: −8.7 [10.0]; LEM5: −18.3 [12.9], <i>P</i>=0.006 vs PBO; LEM10: −17.4 [11.6], <i>P</i>=0.003 vs PBO).Median decreases from baseline in sSOL (min) were significantly greater with LEM5 and numerically greater with LEM10 vs PBO (PBO: −9.0; LEM5: −20.1, <i>P</i>=0.0008 vs PBO); LEM10: −19.8) at 6 months. At baseline, mean (SD) sSE was 61.8% (18.1%), 65.2% (14.3%) and 61.0% (14.6%) for PBO, LEM5 and LEM10, respectively. Mean (SD) increases (improvement) from baseline in sSE were significantly greater with LEM5 and numerically greater with LEM10 vs PBO at 6 months (PBO: 5.8% [10.3%]; LEM5: 17.1% [14.3%], <i>P</i>=0.0012 vs PBO; LEM10, 13.1% [14.0%]). Lastly, mean sWASO (min) at baseline was 134.9 (82.3), 126.8 (65.1) and 166.4 (91.0) for PBO, LEM5 and LEM10, respectively. At 6 months, mean (SD) decreases (improvement) from baseline in sWASO (min) were significantly greater with LEM for both doses vs PBO (PBO: −9.9 [47.2]; LEM5: −58.3 [79.9], <i>P</i>=0.004 vs PBO; LEM10, −50.6 [56.6], <i>P</i>=0.03 vs PBO). Overall, treatment –emergent adverse events (AE) rates were similar across treatment groups (58.5%, 65.9%, 53.1% for PBO, LEM5 and LEM10, respectively). The most common AEs (≥5% in any LEM group and >PBO) were somnolence (0%, 11.4%, 22.4%), nasopharyngitis (4.9%, 6.8%, 8.2%), gastroenteritis (0%, 2.3%, 8.2%), upper abdominal pain (0%, 2.3%, 6.1%), diarrhea (0%, 0%, 6.1%), and vomiting (0%, 0%, 6.1%) in PBO, LEM5, LEM10, respectively. <h3>Conclusions</h3> In this post hoc analysis from Study 303, subjects aged ≥65y with clinically significant fatigue at baseline had greater improvements in FSS-TS and all sleep parameters with LEM vs PBO at 6 months. Reductions in fatigue severity generally paralleled the time course of sleep parameter improvements. <h3>Funding</h3> Eisai Inc.

Prevalence and associated factors of DSM-5 insomnia disorder in the general population of Qatar

BackgroundEpidemiological studies of insomnia in the Middle East remain scarce. The present study aimed to estimate the prevalence of insomnia and explore its associations in the general population of Qatar. With almost 100 nationalities, Qatar is one of the most culturally diverse, richest, and fastest developing countries in the Arabian Peninsula.MethodsA probability sample of community-dwelling adults were surveyed in February of 2019. A total of 1611 respondents completed face-to-face interviews in Arabic or English. Logistic regression modeled associations with insomnia, our dependent variable, as defined by a score of ≤16 on the eight-item Sleep Condition Indicator or according to criteria for insomnia in the Diagnostic & Statistical Manual of Mental Disorders, fifth edition or DSM-5.ResultsApproximately, 5.5% of the sample screened positive for insomnia and the 30-day prevalence of those who met all the DSM-5 criteria for insomnia disorder was 3.0%. In addition, 2.0% of the sample screened positive for depression and 3.4% for anxiety in the past 2 weeks. Multivariable analysis showed the following were significantly associated with insomnia: Arab ethnicity, young age, unemployment, being married, having less than high school education, fair or poor health, anxiety, and depression.ConclusionsInsomnia prevalence was in the lower range of previously reported DSM-defined estimates from developed Western countries. Our findings highlight the need for raising awareness and improving sleep hygiene in potential risk groups such as younger adults and those of Arab ethnicity, in addition to incorporating insomnia screening in the provision of mental health services.

0465 Association Between Physical or Sexual Abuse and Sleep Reactivity in Patients with Insomnia

Abstract Introduction Physical and sexual abuse are common and have demonstrated associations with insomnia. A common factor predisposing individuals to the development of insomnia is sleep reactivity, yet no studies have determined the relationship between sleep reactivity and physical and/or sexual abuse. Methods Patients with DSM-5 insomnia disorder (N = 658; 519 F; mean age = 45.03) participated in an online randomized controlled trial of behavioral treatment of insomnia. Participants completed the Insomnia Severity Index (ISI), Ford Insomnia Response to Stress Test (FIRST), and demographic information at baseline. Abuse history was assessed with a single 4-choice item asking participants if they had a history of physical or sexual abuse. One-way analysis of variance was used to determine the level of sleep reactivity in each of the 4 abuse groups (none, physical, sexual, both) controlling for insomnia (ISI). Post-hoc analyses also compared differences in self-reported difficulties falling and staying asleep. Results Compared to those with no abuse history (n = 465), patients who reported both physical and sexual abuse (n = 50) had significantly elevated FIRST scores (p &amp;lt; .001). Results remained significant after controlling for severity of insomnia, age, and gender. Post-hoc analyses showed group differences in sleep onset latency but not wake after sleep onset. Conclusion Combined physical and sexual abuse are associated with higher levels of sleep reactivity to stress, and that the effects may be most prominent for difficulties falling asleep and not sleep maintenance. Prospective studies are needed to determine the potential effects of abuse on sleep reactivity, and whether sensitization of the sleep system to stress constitutes an etiological pathway in the development of insomnia disorder in survivors of abuse. Future work should also investigate potential overlapping biological markers of abuse and sleep reactivity. Support This study was funded by the Robert Wood Johnson Foundation (PI: Drake).

0504 Efficacy and Safety of Seltorexant in Insomnia Disorder

Abstract Introduction Insomnia disorder affects 3-6% of the population and includes functional impairing symptoms for ≥3 months. Current hypnotics have limitations (eg fall risk, dependency, parasomnia, cognitive impairment). In a previous proof-of-concept study, seltorexant, a selective orexin-2 receptor antagonist, dosed at 40mg nightly improved sleep efficiency, latency to persistent sleep (LPS), and wake after sleep onset (WASO) versus placebo. Methods A multicenter, double-blind, randomized, parallel-group, active- and placebo-controlled, 14-day, dose-finding study (NCT03375203) assessed the efficacy and safety of seltorexant in adult and elderly subjects meeting DSM-5 insomnia disorder criteria. Subjects were randomized (1:1:1:1:1 ratio) to: placebo, seltorexant 5mg, 10mg, 20mg, or zolpidem. Primary endpoint: Based on PSG, dose response in LPS change on Night 1 relative to baseline. Secondary endpoints included change from baseline in: WASO over the first 6 hours (WASO-6) on Night 1, and LPS and WASO-6 on Night 13. Multiple Comparison Procedure-Modeling, ANCOVA and MMRM were used for data analyses. Results 365 patients were randomized and 347 (95%) completed the double-blind phase with 68% women and median age of 59yr (22 to 84yr). Statistically significant dose-response relationship (p-value &amp;lt;0.001) was observed for LPS at Night 1 (5mg=12%, 10mg=36%, 20mg=49% improvement compared with placebo). Similar findings were observed for WASO-6 and benefits sustained from Night 1 to 13. The 20 mg dose showed greater improvement than zolpidem on LPS at Nights 1 and 13 and on WASO-6 at Night 13. Overall treatment-emergent adverse events rates were comparable in the seltorexant, placebo, and zolpidem treatment groups. Conclusion Statistically significant and clinically meaningful improvements on LPS &amp; WASO-6 were observed for seltorexant 10 and 20mg dose groups versus placebo. No safety concerns were observed. Seltorexant with its novel mechanism holds potential as a new treatment for insomnia disorder. Support

Validity, potential clinical utility and comparison of a consumer activity tracker and a research-grade activity tracker in insomnia disorder II: Outside the laboratory.

Accurate assessment of sleep can be fundamental for monitoring, managing and evaluating treatment outcomes within diseases. A proliferation of consumer activity trackers gives easy access to objective sleep. We evaluated the performance of a commercial device (Fitbit Alta HR) relative to a research-grade actigraph (Actiwatch Spectrum Pro) in measuring sleep before and after a cognitive behavioural intervention in insomnia disorder. Twenty-five individuals with DSM-5 insomnia disorder (M=50.6±15.9years) wore Fitbit and Actiwatch and completed a sleep diary during an in-laboratory polysomnogram, and for 1week preceding and following seven weekly sessions of cognitive-behavioural intervention for insomnia. Device performance was compared for sleep outcomes (total sleep time, sleep latency, sleep efficiency and wake after sleep onset). The analyses assessed (a) agreement between devices across days and pre- to post-treatment, and (b) whether pre- to post-treatment changes in sleep assessed by devices correlated with clinical measures of change. Devices generally did not significantly differ from each other on sleep variable estimates, either night to night, in response to sleep manipulation (pre- to post-treatment) or in response to changes in environment (in the laboratory versus at home). Change in sleep measures across time from each device showed some correlation with common clinical measures of change in insomnia, but not insomnia diagnosis as a categorical variable. Overall, the Fitbit provides similar estimates of sleep outside the laboratory to a research grade actigraph. Despite the similarity between Fitbit and Actiwatch performance, the use of consumer technology is still in its infancy and caution should be taken in its interpretation.

Qualitative Examination of Daytime Monitoring and Selective Attention in Insomnia

PurposeInsomnia is partly maintained by selective attention and monitoring for cues that indicate the presence of a poor night’s sleep. However, little published work examining the role of selective attention in insomnia from a qualitative perspective exists.MethodsEleven participants with DSM-5 insomnia disorder completed semi-structured interviews.Results“Thematic analysis” revealed two prominent, yet interrelated, themes: impairment to daytime functioning and selective attention and monitoring. Perceived difficulty initiating and maintaining asleep during the biological night was accompanied by increased efforts during the day to complete mundane tasks. In addition, reports of consciously selectively attending to sleep-related cues on awakening were frequent, and for some this behaviour extends throughout the day.ConclusionThe current outcomes provide first-person support for cognitive models of the disorder. Treatment approaches may wish to target and alleviate selective attention in insomnia.

Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education.

Insomnia is a leading cause of disability in postmenopausal women. Multicomponent cognitive-behavioral therapy for insomnia (CBTI) is a first-line treatment for chronic insomnia, but support for its efficacy in treating menopause-related insomnia is scarce. The present study evaluated whether CBTI is an efficacious treatment for menopause-related chronic insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious compared with CBTI. In a single-site, randomized controlled trial, 150 postmenopausal women (56.44 ± 5.64 years) with chronic DSM-5 insomnia disorder related to menopause were randomized to three treatment conditions: sleep hygiene education (SHE), SRT, or CBTI. Blinded assessments were performed at baseline, posttreatment, and 6 months after treatment. The Insomnia Severity Index (ISI) and sleep diaries served as primary outcomes. From baseline to posttreatment, ISI decreased 7.70 points in the CBTI group (p < .001), 6.56 points in the SRT group (p < .001), and 1.12 in the SHE group (p = .01). Although average sleep duration increased in all groups by 6 month follow-up, CBTI patients obtained 40-43 more minutes of nightly sleep than those who received SHE or SRT. Remission rates in the CBTI (54%-84%) and SRT (38%-57%) groups were higher than SHE patients (4%-33%) at posttreatment and 6 month follow-up. CBTI patients were generally more likely to remit than SRT patients. CBTI and SRT effectively treat menopause-related insomnia disorder and are superior to SHE. Response to CBTI and SRT is similar, but CBTI outperforms SRT in improving sleep maintenance, which may increase likelihood of remission. Clinical Trial Name: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.

Evaluating DSM-5 Insomnia Disorder and the Treatment of Sleep Problems in a Psychiatric Population.

With the introduction of insomnia disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), greater emphasis has been placed on the diagnosis and treatment of sleep disorder even in the presence of a coexisting mental disorder. The current study seeks to explore the clinical picture of insomnia in the context of psychiatric disorders commonly associated with sleep complaints by assessing the prevalence and correlates of DSM-5 insomnia disorder, and examining the extent to which insomnia symptoms have been addressed in this population. Four hundred treatment-seeking outpatients suffering from depressive, bipolar affective, anxiety, and schizophrenia spectrum disorders were recruited. DSM-5 insomnia was established using the modified Brief Insomnia Questionnaire. Differences in sociodemographic factors, clinical status, impairment outcomes, and mental health services utilization were compared. Information on patients' help-seeking experiences for insomnia-related symptoms was collected to determine the treatment received and treatment effectiveness. Almost one-third of our sample (31.8%) had DSM-5 insomnia disorder. Those with insomnia disorder had significantly higher impairment outcomes than their counterparts but no group difference was observed for mental health services utilization. Findings based on past treatment contact for sleep problems suggest that diagnosis and treatment of insomnia is lacking in this population. With the new calling from DSM-5, clinicians treating psychiatric patients should view insomnia less as a symptom of their mental illnesses and treat clinical insomnia as a primary disorder. Patients should also be educated on the importance of reporting and treating their sleep complaints. Nonmedical (cognitive and behavioral) interventions for insomnia need to be further explored given their proven clinical effectiveness.