bluuebunny/crossref_metadata_2025_split huggingface dataset:
0437 Psychometric Evaluation of the Insomnia Severity Index in Nurses
Authors: Emert Sarah , Nagy Samantha , Dietch Jessica , Taylor Daniel 
Published: May 2022

Abstract

Introduction
This secondary analysis was conducted to examine the psychometric properties of the Insomnia Severity Index (ISI) in a sample of non-shift working nurses. Insomnia is a common sleep disorder and has been linked to poor physical, psychological, and cognitive outcomes and increased accidents. Unique features of this sample (e.g., long shifts, patient care, quick emergency response) create a need for population-specific validation of the commonly used ISI. Study I assessed convergent and discriminant validity between the ISI, sleep diary, and other sleep and psychosocial measures. Study II assessed the test-retest validity of the ISI.

Methods
Participants (N = 289) were nurses from two regional hospitals in north Texas recruited for a parent study (268 females, M age = 40.67 years; SD = 11.03; 79.9% White) who completed daily sleep diaries and sleep and mental health screeners at four timepoints. Shift workers and participants who did not complete the ISI at baseline were excluded from the analysis.

Results
The ISI had medium to large correlations with measures intended to establish convergent validity including sleep onset latency (r = .41), wake time after sleep onset (r = .40), sleep efficiency (r = -.45), sleep quality (r = .66), and sleep related impairment (r = .67). Examination of ISI items and analogous sleep diary parameters showed small to large correlations (rs = .13-.53). The ISI had small to large correlations with measures intended to establish discriminant validity including nightmares (r = .25), circadian preference (r = -.26), shiftwork-related disorders (r = .09) and PTSD (r = .36), depression (r = .69), anxiety (r = .51), and perceived stress (r = .43). The ISI demonstrated good test-retest reliability from baseline to 1-month (ICC = .88), 6-month (ICC = .77), and 11-month follow up (ICC = .74).

Conclusion
The ISI demonstrated good psychometric properties and is a psychometrically strong measure for the assessment of insomnia severity in nurses. Overlap with psychological symptoms suggests caution while interpreting these constructs.

Support (If Any)
This study was supported by a grant from the National Institute of Allergy and Infectious Diseases, Grant/Award Number: R01AI128359-01.
0440 Subjective Sleep Outcomes with Lemborexant Among Subjects with Insomnia and Clinically Meaningful Decreases on the Insomnia Severity Index
Authors: Roth Thomas , Moline Margaret , Pinner Kate , Yardley Jane , Pappadopulos Elizabeth , Malhotra Manoj 
Published: May 2022

Abstract

Introduction
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 sleep outcomes including patient-reported (subjective) sleep onset latency (sSOL) and wake after sleep onset (sWASO) versus placebo (PBO). This post-hoc analysis assessed these measures in Insomnia Severity Index (ISI) responders, defined as subjects with clinically meaningful reductions (≥7 points) in ISI total scores (ISI-TS).

Methods
Study 303 was a 12-month, PBO-controlled (first 6mo), randomized, double-blind, phase 3 study in subjects with ISI-TS ≥15 (moderate to severe insomnia). Subjects (n=949; Full Analysis Set [FAS]) received LEM (5mg [LEM5]; 10mg [LEM10]) or PBO for 6mo. Changes from baseline (CFB) in sSOL (min) and sWASO (min) at 6mo were analyzed in ISI responders from the FAS and in subjects with severe insomnia (baseline ISI-TS ≥22), using mixed-effect model repeated measurement analysis.

Results
At 6mo, 175 (LEM5), 151 (LEM10), and 124 (PBO) subjects were ISI responders; of these, 46 (LEM5), 48 (LEM10) and 29 (PBO) had severe insomnia. CFB in the FAS in median sSOL was significantly greater with LEM5 (−21.8) and LEM10 (−28.2) versus PBO (−11.4; both P&lt;0.001). ISI responders also had significantly greater decreases in sSOL with LEM (LEM5: −26.7, P&lt;0.01; LEM10: −32.6, P&lt;0.001) than PBO (−18.0). In ISI responders from the severe insomnia subgroup, greater CFB in median sSOL was observed with LEM10 (−41.4) than with PBO (−32.1; P&gt;0.05), but not with LEM5 (−32.9, P&gt;0.05).Least-squares mean (standard error) CFB in sWASO in the FAS was −46.8(3.7) with LEM5 (P&lt;0.001), −42.0(3.7) with LEM10 (P&lt;0.05), versus −29.3(3.6) with PBO. In ISI responders, CFB in sWASO was greater with LEM10 (−52.7[4.0], P&gt;0.05) and significantly greater with LEM5 (−58.9[3.8], P&lt;0.01) versus PBO (−43.6[4.4]). In ISI responders from the severe insomnia subgroup, greater CFB was observed with LEM5 (−91.6[9.5]) versus PBO (−70.2[11.1]); P&gt;0.05); CFB with LEM10 (−71.4[9.0]) was similar to PBO.

Conclusion
ISI responders including those from the severe insomnia subgroup reported greater CFB in sSOL and sWASO than the FAS that was somewhat dose dependent. LEM generally showed benefit versus PBO.

Support (If Any)
Eisai Inc.
0443 Life Values Expressed by Female Veterans Engaged in an Acceptance and Commitment-based Behavioral Therapy for Primary Insomnia
Authors: Saldaña Kathryn , Revolorio Kaddy , Carlson Gwendolyn , Culver Najwa , Kay Morgan , McGowen Sarah Kate , Song Yeonsu , Martin Jennifer 
Published: May 2022

Abstract

Introduction
Women Veterans disproportionately suffer from insomnia, which negatively impacts health and overall quality of life. Insomnia can result in fewer value-based choices and less engagement in meaningful life activities. This study sought to identify common life values expressed by women Veterans engaged in an acceptance-and commitment-based behavioral therapy for primary insomnia.

Methods
74 female-identifying Veterans (mean age=48.3 years; 47.3% non-Hispanic White, 28.4% Black/African American, 23.0% Hispanic/Latina, 12.2% American Indian/Alaska Native, 5.4% Asian American and 9.5% Other) who met DSM-5 diagnostic criteria for Insomnia disorder were randomly assigned to an acceptance-based behavioral treatment for insomnia called Acceptance of the Behavioral Changes to treat insomnia (ABC-I; compared to a similarly structured group receiving CBT-I). Women in the ABC-I group received 5 weekly, 60-minute sessions containing key components of sleep restriction, stimulus control, and sleep hygiene. In place of traditional cognitive therapy exercises, we incorporated essential components of Acceptance and Commitment Therapy (ACT), such as the identification of values. Outcome measures included qualitative responses of values identified by participants. Qualitative responses were coded by three separate raters who coded participant stated values into five categories: Work/Education, Relationships, Personal Care/Health, Leisure, and Pets.

Results
The three independent coders reached 100% agreement after independent coding and adjudication. The five categories are listed in order of frequency of response: 1) Relationships (n =68); 2) Personal Care/Health (n =51); 3) Work/Education (n =46); 4) Pets (n =12) and; 5) Leisure (n =5).

Conclusion
The current study showed that personal and social relationships are of high importance to women Veterans undergoing behavioral treatment for insomnia, followed by personal care and health, which includes spirituality/religion, and physical and mental health. Findings indicate that incorporating outcomes of insomnia treatment trials that assess relationship quality may prove important in future studies of women Veterans with sleep disorders. Further, identifying common shared values among women Veterans is an important first step in developing and adapting treatments for insomnia that help to improve quality of life.

Support (If Any)
VA HSR&D IIR 13-058-2 and RCS-20-191, NIH K24 HL143055; VA GLAHS GRECC
0448 Self-care trajectories and sleep characteristics in people with heart failure and insomnia
Authors: Conley Samantha , Jeon Sangchoon , OConnell Meghan , Redeker Nancy 
Published: May 2022

Abstract

Introduction
Sleep disturbance is common among people with heart failure (HF) and associated with poor self-care. The purpose of this study, a secondary analysis of data from a randomized controlled trial of the sustained effects of cognitive behavioral therapy for insomnia compared to HF self-management, was to examine the extent to which these interventions improved HF self-care trajectories and the associations between changes in sleep and self-care trajectories.

Methods
We measured changes in self-care maintenance (daily activities), management (symptom management), and confidence (self-efficacy), components of self-care (SC: Self-care of Heart Failure Index) and self-reported sleep characteristics [Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness (PROMIS Sleep Impairment)] at baseline and 3, 6, and 12 months post-intervention. We used group-based trajectory modeling to identify self-care trajectories and generalized linear models to identify the associations between changes in sleep and SC trajectories.

Results
We included 175 participants [N = 91 HS; age M = 63 years (12.9); n = 110 (57.1%) male; n = 133 (76.0%) White]. At baseline, SC maintenance, management, and confidence were poor overall [M = 66.3 (16.4); 53.4 (23.8); 68.1 (20.3), respectively]. We identified four self-care trajectories. Class A (poor SC maintenance & management; moderate confidence: N = 47, 26.9%); Class B (low self-care management & confidence, moderate maintenance: N = 68, 38.9%): Class C (high maintenance & management, low confidence; N = 42, 24.0%); Class D (high on all SC: N = 18, 10.3%). There was no significant difference in changes in self-care over time between HS and HH, but both groups improved at 3 and 6 months on self-care maintenance, and self-care management improved at 12 months over baseline (p &lt; .05). Participants in all classes improved on insomnia severity and sleepiness (p&lt; .05) over time.

Conclusion
We found that insomnia and sleepiness improved even those with poor self-care suggesting that adequate HF SC may not be needed to improve insomnia. Future research is needed to determine if a combination of HF self-management and CBT-I improves SC trajectories in this population.

Support (If Any)
R01NR016191 and P20NR014126
0449 Correlations Between Sleep Parameters and ISI Total Score in Subjects with Moderate to Severe Insomnia Treated with Lemborexant
Authors: Moline Margaret , Roth Thomas , Pinner Kate , Yardley Jane , Pappadopulos Elizabeth , Malhotra Manoj 
Published: May 2022

Abstract

Introduction
Lemborexant (LEM) is a dual orexin receptor antagonist (DORA) 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 post hoc analysis investigated whether changes from baseline in sleep parameters with LEM are correlated with insomnia disorder severity.

Methods
Study 303 was a randomized, double-blind, PBO-controlled (first 6mo [Period 1]), phase 3 study. During Period 1, subjects received LEM 5mg (LEM5), LEM 10mg (LEM10), or PBO. During Period 2 (second 6mo), LEM subjects continued their assigned dose and PBO subjects were rerandomized to LEM5 or LEM10 (rerandomized subjects not reported here). The correlation between changes in subject-reported sleep parameters (sleep onset latency [sSOL], wake after sleep onset [sWASO], sleep efficiency [sSE], total sleep time [sTST]) and insomnia disorder severity, as assessed by the Insomnia Severity Index total score (ISI-TS) were evaluated in the Full Analysis Set (FAS; ISI-TS ≥15) and in a subgroup of subjects with severe (ISI-TS ≥22 at baseline) insomnia over 12mo for LEM and over 6mo for PBO.

Results
Among 949 (PBO=318; LEM5=316; LEM10=315) subjects, 223 (PBO=65; LEM5=84; LEM10=74) had severe insomnia at baseline. Within each sleep parameter and severity group, baseline values were similar across treatments. Overall, strong to very strong correlations were observed between changes from baseline in sleep parameters and decrease in ISI-TS, regardless of treatment, as determined by correlation coefficients for sSOL (LEM5=0.973 [P=0.0053]; LEM10=0.997 [P=0.0002]; PBO=0.844 [P=0.361]), sSE (LEM5=–0.937 [P=0.0188]; LEM10=–0.992 [P=0.0008]; PBO=–0.950 [P=0.2018]), sWASO (LEM5=0.937 [P=0.0187]; LEM10=0.996 [P=0.0003]; PBO=0.979 [P=0.1299]), and sTST (LEM5=–0.876 [P=0.0515]; LEM10=–0.974 [P=0.0050]; PBO=–0.933 [P=0.2346]). Strong to very strong correlations were also observed in subjects with severe insomnia: sSOL (LEM5=0.818 [P=0.0904]; LEM10=0.823 [P=0.0868]; PBO=0.828 [P=0.3788]), sSE (LEM5=–0.860 [P=0.0616]; LEM10=–0.975 [P=0.0048]; PBO=–0.961 [P=0.1792]), sWASO (LEM5=0.871 [P=0.0544]; LEM10=0.936 [P=0.0194]; PBO=0.875 [P=0.3213]), and sTST (LEM5=–0.843 [P=0.0729]; LEM10=–0.969 [P=0.0095]; PBO=–0.974 [P=0.1449]).

Conclusion
Across the study period, changes from baseline in reported nocturnal sleep parameters correlated with reductions in severity of insomnia disorder regardless of insomnia severity at baseline.

Support (If Any)
Eisai Inc.
0455 The Insomnia Daytime Symptoms and Impacts Questionnaire: An Analysis of Clinically Meaningful Change Using Phase 3 Clinical Trial Data
Authors: Phillips-Beyer Andrea , Kawata Ariane , Kleinman Leah , Kinter Dalma Seboek 
Published: May 2022

Abstract

Introduction
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated patientreported outcome (PRO) instrument evaluating daytime functioning in people with insomnia. It comprises 14 items grouped into 3 domains: Alert/Cognition, Mood, and Sleepiness. To further explore the ability of the IDSIQ to capture clinically meaningful changes in daytime functioning resulting from treatment, we estimated withinsubject changes in IDSIQ scores using phase 3 trial data.

Methods
A randomized double-blind placebocontrolled trial of daridorexant in adults with insomnia (NCT03545191), in which subjects completed the IDSIQ daily during treatment, provided data for blinded analyses. Spearman correlations were calculated for changes in IDSIQ scores and potential anchors: Insomnia Severity Index, Patient Global Assessment of Disease Severity, Patient Global Impression of Severity, and Patient Global Impression of Change, applying a prespecified threshold of 0.30 (moderate association). Anchor-based analyses of weekly average IDSIQ total and domain scores were used to estimate responder definitions (RDs). The various RD estimates were triangulated to identify values where they converged. Distribution-based and receiver operating characteristic analyses calculated standard error of measurement (SEM), 0.5 standard deviation (SD), and Youden’s index as supportive evidence for anchor-based RD estimates.

Results
The analysis included 930 subjects (18-88 years). Score change correlations for the potential anchors and IDSIQ at month 1 (0.36–0.44) and month 3 (0.45–0.57) were all &gt;0.30. Triangulation of mean IDSIQ score changes in subjects with clinically relevant improvement on the different anchors supported RD thresholds for clinically meaningful change of 17 points for the IDSIQ total score, 9 points for the Alert/Cognition domain, 4 points for the Mood domain, and 4 points for the Sleepiness domain. SEM and 0.5 SD values were within the ranges of anchor-based IDSIQ score changes, and Youden’s index was maximized or near-maximized when the RD estimates were used as thresholds for identifying responders based on the anchors.

Conclusion
The IDSIQ is sensitive to changes in patients who experience daytime impacts of insomnia and can be used to assess treatment efficacy on daytime functioning in patients with insomnia.

Support (If Any)
This work was funded by Idorsia Pharmaceuticals Ltd.
0459 The First Step of a Triaged Stepped-Care Delivery of CBTI: A Preliminary Report from the RESTING Study
Authors: Manber Rachel , Kim Jane , Simpson Norah , Tully Isabelle , Tutek Joshua , Dietch Jessica , Gumport Niki , Rosas Lisa , Zulmann Donna , Palaniappan Latha 
Published: May 2022

Abstract

Introduction
Both online and therapist-led cognitive behavioral therapy for insomnia (CBTI) are effective. However, little is known about the optimal combination and sequence to maximize both access and effectiveness. The RESTING study is a randomized controlled trial assessing the effectiveness of a triaged stepped care approach (STEPPPED-CARE) to delivering CBTI that utilizes a simple five-item Checklist to determine which patients should start treatment with online versus therapist-led CBTI.

Methods
Adults 50 years and older (N=222; age = 63.1 (SD=8.2); 74% female) with insomnia disorder who met the study’s broad eligibility criteria were randomized to STEPPED-CARE (N=112) or to ONLINE-ONLY CBTI (N=110). Participants in the STEPPED-CARE arm who responded yes to any Checklist item (Checklist Yes) received therapist-led CBTI (N=61); the rest (Checklist NO) received the online CBTI program Sleepio (N=62). All participants in the ONLINE-ONLY arm received Sleepio. Randomization was stratified by Checklist (Yes/No). We used mixed effects models with an Arm by Checklist by Time interaction to determine the effect of STEPPED-CARE on insomnia severity two months after randomization, using the Insomnia Severity Index (ISI).

Results
A mixed effects model revealed an Arm by Checklist by Time interaction (p=0.013). Post-hoc analyses within stratum revealed that within the Checklist Yes stratum, participants assigned to STEPPED-CARE (all received therapist-led treatment) experienced significantly greater reduction in ISI (from 16.2 (SD=1.2) to 11.6 (SD=2.1)) than those assigned to ONLINE-ONLY (from 16.2 (SD=1.2) to 13.7 (SD=1.4); p=0.007, d=0.22). Among those in the Checklist No stratum, there was no Arm difference in ISI change. The combined mean ISI in the Checklist No group was 14.8 (0.8) at baseline and 11.2 (0.8) at 2 months. Overall, remission of insomnia (ISI&lt;8) was attained by 23% of those in STEPPED-CARE and 15% of those assigned to ONLINE-ONLY.

Conclusion
Results support the efficacy of the first step of a triaged stepped care approach to CBTI among middle age and older adults with insomnia disorder. Given minimal exclusion criteria, results from the current trial are generalizable to individuals with comorbidities and those who use hypnotics, offering a way to triage patients to digital or therapist-led CBTI effectively and efficiently.

Support (If Any)
R01AG057500
0461 Does “TIB” Differentiate Between Good Sleepers and Subjects That Develop Acute or Chronic Insomnia? A 2nd Analyses
Authors: Perlis Michael , Morales Knashawn , Grandner Michael , Posner Donn , Vargas Ivan , Seewald Mark , Muench Alexandria , Boyle Julia , Ellis Jason 
Published: May 2022

Abstract

Introduction
According to the 3P model of insomnia, the variable that mediates the transition from acute to chronic insomnia is “sleep extension” (the behavioral tendency to expand sleep opportunity to compensate for sleep loss). Recently, this proposition was prospectively evaluated by assessing how Time-in-Bed (TIB) varied, week-by-week, relative to the incidence of acute insomnia in four groups, those that: maintained good sleep (GS,n=911), recovered good sleep (AI-REC,n=244); had persistent poor sleep (AI-PPS,n=65); and developed chronic insomnia (AI-CI,n=23)). Significant differences for pre-to-post acute insomnia TIB were not detected for the insomnia groups (as compared to one another or as compared to GSs). The observed trends suggested that the increases in TIB observed were minor (&lt; 15 min overall, at 2 weeks, and at 12 weeks post AI). In the present analysis, a more granular evaluation was undertaken to assess whether sleep extension occurs on the nights following poor sleep bouts.

Methods
The same data set and subject groups were modeled for TIB occurring on the night following a poor night’s sleep (≥ 30 min for SL or WASO or EMA) for the post-acute insomnia interval (by weekday and weekend). Linear mixed effects model was used to account for up to 1 year of repeated nights per subject.

Results
During the weekdays, the groups did not differ with respect to TIB following a poor nights’ sleep. On average, the four groups (including good sleepers) did not vary TIB by more than 5 minutes. During the weekends, all four groups tended to restrict TIB. In this instance, AI-CI subjects restricted TIB the least (AI-CI -17.2[5.11]; (GS -25.7[SE 1.58]; AI-PPS -27.6[6.1]; AI-REC -32.3[1.9].

Conclusion
As with the prior analysis, the transition to CI does not appear to be triggered by sleep extension. In the present analysis there is some evidence to support the notion that AI-CI subjects restrict TIB less. This counterintuitive finding needs to be further evaluated taking into account sleep timing. That is, time-to-bed and time-out-of-bed may vary (show the attempt to extend sleep opportunity) while TIB does not change appreciably (owing to limitations in sleep ability [plasticity]).

Support (If Any)
Support: R01AG041783;K24AG055602;R01AT003332
0463 Sleep Assessed by Actigraphy during Discontinuation of Chronic Hypnotic Use
Authors: Parashar Vartika , Koshorek Gail , Roth Thomas , Roehrs Timothy 
Published: May 2022

Abstract

Introduction
Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical problem. Sleep was recorded by actigraphy during a two-week discontinuation in an on-going “blinded” clinical trial in which people with insomnia were instructed to discontinue their study medication after 6 months of nightly use.

Methods
DSM-V diagnosed people with insomnia (n=39, 34 females), aged 26-61 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=15, B: n=11, C: n=13). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Sleep was recorded by actigraphy and sleep latency (LAT), wake after sleep onset (WASO), and sleep efficiency (SE) were determined.

Results
Twenty subjects (51%) stopped taking study medication when told to discontinue, while 19 took a median of 3 capsules over the 14 nights. The number of capsules chosen declined from week 1 to week 2 (p&lt;.005), while WASO (7-night means) increased from week 1 to week 2 (p&lt;.02). However, LAT, WASO, and SE never went beyond the 7-night means recorded at baseline. Discontinuation night 1 and 2 also did not differ from baseline nights 1 and 2.

Conclusion
Most participants successfully discontinued hypnotic use when instructed to do so. While some degree of sleep disturbance returned, it never exceeded the baseline levels.

Support (If Any)
NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.