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In this Round Table Discussion, an international panel of experts discuss issues related to the use of technology in the delivery of cognitive behavioral therapy for insomnia (CBT-I), in order to increase its reach. Panelists were, in alphabetical order, Carmela Alcántara, PhD, an Associate Professor at Columbia University School of Social Work in New York, USA, Bei Bei, PhD., an Associate Professor at Monash University in Melbourne, Australia, Charles M. Morin, PhD., a Professor of Psychology at Laval University in Quebec City, Canada, and Annemieke A. van Straten, PhD., a Professor of Clinical Psychology at the Vrije Universiteit in Amsterdam, the Netherlands. The session was chaired by Rachel Manber, PhD., a Professor of Psychiatry and Behavioral Sciences at Stanford University, in Palo Alto, California, USA. In their introductions each panelist discussed the use of technology in their respective country. All indicated that the most common way technology is used in the treatment of insomnia is through the use of video calls (telemedicine) to deliver individual CBT-I, and that this is mostly covered by publicly funded health insurance programs such as Medicare, especially since the COVID-19 pandemic. There are also some fully automated insomnia treatment programs, but they’re often not covered by Medicare or other health insurance programs.

BACKGROUND Sleep bruxism (SB) is an oral behavior that is characterized by high levels of repetitive jaw muscle activity and may develop into a disorder. The etiology of SB is not well understood, and there is currently no curative treatment for SB. Several studies have suggested associations between SB and maladaptive emotion regulation (ER). OBJECTIVE The aim of this study is to test whether ER is impaired in individuals with SB. METHODS To more directly probe these associations, this study measured trait and state SB and ER alongside affect and sleep variables. We collected self-reported and physiological data, using individual-difference questionnaires and 14-day ecological momentary and ambulatory assessments. We will test for maladaptive ER in terms of strategy use frequency and effectiveness as a function of SB while controlling for affect and sleep. RESULTS This research received funding in April 2017. Data collection took place from August 2020 to March 2022. 238 participants were eligible and completed the study. Data analysis has not yet started. CONCLUSIONS We hope that the effort to thoroughly measure SB and ER using gold-standard methods and cutting-edge technology will advance knowledge of SB as well as more effective interventions through ER to alleviate the pain and distress of those impacted. CLINICALTRIAL 1R01DE026771-01

BACKGROUND Sleep problems are common and costly in the U.S. military. There is a gross shortage of trained specialist providers to address sleep problems. Telehealth and mobile health represent promising approaches to increase access to high quality and cost-effective care. OBJECTIVE The purpose of this study was to present preliminary data regarding patient engagement and provider perceived effectiveness gathered during a pilot study of a novel sleep telehealth platform that included a mobile app and integrated wearable sensors (i.e., a commercial off-the-shelf sleep tracker [Fitbit]). METHODS Patients with sleep problems were recruited from the Internal Medicine clinic at Walter Reed National Military Medical Center. Patients completed intensive remote monitoring assessments over ten days (baseline intake questionnaire, daily sleep diaries, 2x/daily symptom surveys), and wore a Fitbit. Following the remote monitoring period, patients received assessment results and personalized sleep education in the mobile app. Providers received a provisional patient-assessment report in editable electronic document format. Patient engagement was assessed via behavioral metrics, and providers completed an anonymous effectiveness survey. RESULTS Thirty-five patients with sleep problems participated in the study. Results indicated a high level of engagement with the sleep telehealth platform. Twenty-four primary care providers also participated. Survey responses indicated high levels of perceived effectiveness and identified several potential benefits from adopting a sleep telehealth approach throughout the U.S. military healthcare system. CONCLUSIONS Sleep telehealth approaches represent one potential pathway to increase access to evidence-based care in the U.S. military. Further evaluation of the novel sleep telehealth platform is warranted.

It has long been thought that links between affect and sleep are bidirectional. However, few studies have directly assessed the relationships between (1) pre-sleep affect and sleep EEG activity, and (2) sleep EEG activity and post-sleep affect. This study aims to systematically explore the correlations between pre-/post-sleep affect and EEG activity during sleep. In a community sample of adults (n=51), we measured participants’ positive and negative affect in the evening before sleep and in the next morning after sleep. Participants slept at their residence for one night of EEG recording. Using Fourier transforms, the EEG power at each channel was estimated during rapid eye movement (REM) sleep and non-REM (NREM) sleep for the full range of sleep EEG frequencies. We first present heatmaps of the raw correlations between pre-/post-sleep affect and EEG power during REM and NREM sleep. We then thresholded the raw correlations with a medium effect size |r| ≥ 0.3. Using a cluster-based permutation test, we identified a significant cluster indicating a negative correlation between pre-sleep positive affect and EEG power in the alpha frequency range during REM sleep. This result suggests that more positive affect during the daytime may be associated with less fragmented REM sleep that night. Overall, our exploratory results lay the foundation for confirmatory research on the relationship between daytime affect and sleep EEG activity.

Background Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. Methods This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. Results In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012–0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. Conclusions A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.

Introduction Rates of sleep disturbance and depressed mood increased during the COVID-19 pandemic. Acute symptoms of sleep disturbance may develop into chronic insomnia if left untreated and constitute a risk for depression. However, the impact of early treatment of insomnia symptoms on the development of chronic insomnia and depressive symptoms remains unknown. Here we present the primary outcome results from a pre-registered, 2-arm randomized controlled feasibility trial launched early in the pandemic, investigating whether a brief telehealth insomnia intervention targeting acute insomnia symptoms prevents the subsequent deterioration of insomnia and depression. Methods Forty-nine participants with pandemic-onset insomnia symptoms were randomized to receive four telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) over five weeks or to a waitlist control. Primary outcome measures included the Insomnia Severity Index and the Patient Health Questionnaire-9 excluding the sleep item collected at weeks 0, 6, 12, and 28. Linear mixed-effects models tested the hypotheses that early insomnia intervention improves the 28-week trajectory of insomnia and depressive symptoms relative to the control group. The MacArthur framework tested if improvement of insomnia mediates subsequent improvement in depression. Results The two linear mixed-effects models revealed significant time-by-intervention interactions, indicating improved trajectories of insomnia and depressive symptoms across the 28-weeks in the CBT-I group compared to the control group (Insomnia: B=-1.03, p0.203). In contrast, depression symptom improvement during treatment was not associated with insomnia symptoms (all timepoint p's>=0.132). The percentage of participants with insomnia diagnosis was lower in the CBT-I vs control group at both timepoints (short-term: 21.7% vs. 50%; long-term: 22.7% vs. 50%). Conclusion These are the first findings establishing that brief telehealth CBT-I significantly improved both acute pandemic-onset insomnia symptoms and subsequent trajectory of insomnia and depression. Although the sample size was small and pandemic conditions may never fully be replicated, these results support treatment of acute sleep disturbance in the context of stressors for improved long-term sleep and mood symptoms. Support (if any)

Examine bidirectional associations between daytime napping and nighttime sleep among pregnant individuals with insomnia disorder.We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy (n=116). Participants in their second or third trimester of pregnancy self-reported daytime napping and nighttime sleep parameters using a sleep diary and wore an Actiwatch-2 during the same seven-day period. Linear regression models, accounting for intraindividual correlation, were used to estimate associations between daytime napping and nighttime sleep parameters (duration, efficiency, quality, awakenings). Models were also stratified by trimester of pregnancy.Sixty-three percent of participants reported napping on at least one day. Among participants in the second trimester (65%), napping 15-59 minutes was associated with 6.3% greater self-reported sleep efficiency (95% CI: 2.3, 10.2) and 0.5 units greater self-reported sleep quality (95% CI: 0.0, 0.9) that night; napping 60+ minutes was associated with 0.6 hours shorter actigraphy-measured sleep duration (95% CI: -1.0, -0.2). Napping was not associated with nighttime sleep overall or during the third trimester. Nighttime sleep parameters were not associated with napping duration the following day.Among pregnant individuals with insomnia in the second trimester, short napping duration was associated with higher self-reported sleep efficiency and quality; long napping duration was associated with shorter actigraphy-measured sleep duration. Additional research is needed to examine the interaction between nap duration and nap timing. In the future, these results may lead to more nuanced recommendations for daytime napping among pregnant individuals with insomnia disorder.Registry: ClinicalTrials.gov; Title: Treatment for Insomnia during Pregnancy; Identifier: NCT01846585; URL: https://clinicaltrials.gov/ct2/show/NCT01846585.

Sleep health tends to worsen during adolescence, partially due to pubertal-related changes that, in combination with social and psychological factors, can lead to long-lasting impairments in sleep health and affective functioning. Discrepant findings between subjective and objective measures of sleep in relation to affect have been reported in studies of adults; however, few investigations have assessed both subjective and objective sleep quality in a single sample, and fewer have examined this in the context of pubertal development. We aimed to (1) characterise pubertal associations with subjective sleep satisfaction, objective sleep efficiency, and objective and subjective sleep duration in adolescents; (2) examine the longitudinal association between daily affect and sleep metrics; and (3) test whether pubertal stage moderated this association. Eighty-nine participants (64% female, ages 13-20) completed an ecological momentary assessment (EMA) and actigraphy protocol. Independent of age, advanced pubertal stage was associated with lower subjective sleep satisfaction but not with objective sleep indices. Subjective sleep satisfaction was associated with within-person trajectories of negative affect, but not with positive affect. Pubertal stage and sleep satisfaction did not interact to predict within-day negative or positive affect. These findings are consistent with previous reports showing that objective and subjective sleep health are associated differently with puberty, and that subjective sleep health is associated with daily affect. Pubertal stage may be a more important indicator of subjective sleep quality in adolescence than is chronological age, most likely due to hormonal changes and psychological adjustment to the physical changes associated with the pubertal transition.

Introduction Sleep disorders’ are highly prevalent among U.S. active duty service members (ADSMs) and present well-documented challenges to military health, safety, and performance. In addition to increased need for sleep medicine services, a major barrier to effective sleep management has been a lack of alignment among patients, health providers, and economic-decision-makers. To address this gap in knowledge, the purpose of the present study was to engage diverse stakeholders vested in improving sleep disorders’ management in the military. Materials and Methods We elicited feedback from ADSMs with sleep disorders (five focus group discussion, n = 26) and primary care managers (PCMs) (11 individual semi-structured interview) in two military treatment facilities (MTFs) in the National Capitol Region, in addition to national level military and civilian administrative stakeholders (11 individual semi-structured interview) about their experiences with sleep disorders’ management in U.S. MTFs, including facilitators and barriers for reaching a definitive sleep diagnosis, convenience and effectiveness of sleep treatments, and key desired outcomes from interventions designed to address effectively sleep disorders in the U.S. military health care system (MHS). Recordings from focus groups and semi-structured interviews were transcribed verbatim and analyzed using QSR International’s NVivo 12 software using inductive thematic analysis. The study was approved by Walter Reed National Military Medical Center Department of Research Programs. Results Active duty service members with sleep disorders often fail to recognize their need for professional sleep management. Whereas PCMs identified themselves as first-line providers for sleep disorders in the military, patients lacked confidence that PCMs can make accurate diagnoses and deliver effective sleep treatments. Active duty service members cited needs for expeditious treatment, educational support and care coordination, and support for obtaining sleep treatments during deployment. Challenges that PCMs identified for effective management include insufficient time during routine care visits, delays in scheduling testing procedures, and limited number of sleep specialists. Primary care managers suggested offering evidence-based telehealth tools and enhanced care coordination between PCMs and specialists; standardized medical education, materials, and tools; patient preparation before appointments; self-administered patient education; and including behavioral sleep specialists as part of the sleep management team. For administrative stakeholders, key outcomes of enhanced sleep management included (1) improved resource allocation and cost savings, and (2) improved ADSM safety, productivity, and combat effectiveness. Conclusion Current military sleep management practices are neither satisfactory nor maximally effective. Our findings suggest that solving the military sleep problem will require sustained effort and ongoing collaboration from ADSM patients, providers, and health systems leaders. Important potential roles for telehealth and technology were identified. Future research should seek to enhance implementation of sleep management best practices to improve outcomes for patients, providers, MHS, and the military as a whole.

Everyday experience suggests that sleep and affect are closely linked, with daytime affect influencing how we sleep, and sleep influencing subsequent affect. Yet empirical evidence for this bidirectional relationship between sleep and affect in non-clinical adult samples remains mixed, which may be due to heterogeneity in both construct definitions and measurement. This conceptual review proposes a granular framework that deconstructs sleep and affect findings according to three subordinate dimensions, namely domains (which are distinct for sleep and affect), methods (i.e., self-report vs. behavioral/physiological measures), and timescale (i.e., shorter vs. longer). We illustrate the value of our granular framework through a systematic review of empirical studies published in PubMed (N = 80 articles). We found that in some cases, particularly for sleep disturbances and sleep duration, our framework identified robust evidence for associations with affect that are separable by domain, method, and timescale. However, in most other cases, evidence was either inconclusive or too sparse, resulting in no clear patterns. Our review did not find support for granular bidirectionality between sleep and affect. We suggest a roadmap for future studies based on gaps identified by our review and discuss advantages and disadvantages of our granular dimensional framework.

Introduction Prior studies have shown that CBTI improves patient reported outcomes including daytime fatigue, mood status and quality of life, yet there are limited data concerning the effects of therapy on objective measures of daytime function. The current study tested the effects of CBTI on measures derived from the psychomotor vigilance test (PVT) in a sample of patients with comorbid insomnia disorder and sleep apnea. Methods Patients with insomnia and comorbid OSA, who were prescribed PAP therapy (N =155; Mage= 56.8±12.5 yrs.; 58.1% women) were randomized to digital CBTI (dCBTI) or Sleep Hygiene (CTRL). They completed PVT at baseline and after 8 weeks of treatment. Patients in the dCBTI arm who reached remission were offered no additional insomnia treatment, whereas those who did not were randomly assigned to 8 weeks of continued access to dCBTI or to a therapist delivered CBTI. Patients again completed the PVT after this second 8-week treatment phase. PVT outcome measures included mean reaction time, attentional lapses and efficiency scores. Linear mixed models were used to compare the PVT measures of patients receiving either of the CBTI treatment sequences with those assigned to the CTRL. Results Analyses showed significant group x time interactions for PVT attentional lapses (F = 3.04; p < .05) and for efficiency scores (F= 4.06; p< .025). Those who received either of the CBTI treatment sequences showed a greater reduction in attentional lapses and greater improvement in their efficiency scores from baseline to the post-treatment assessments than did those assigned the CTRL. Conclusion Findings indicate that CBTI improves objective indices of daytime cognitive functioning among those with comorbid apnea and insomnia disorder. Further tests of CBTI’s effects on these and other measures of cognitive functioning are warranted in other samples of insomnia patients who do and do not have medical, psychiatric and sleep disorder comorbidities. Support (if any) Funding support from the National Heart, Lung and Blood Institute, Grant # 1R01HL130559-01A1.

Adults are thought to show a sleep-stress spiral in which greater stress worsens sleep quality, which amplifies stress, which leads to worse sleep. This study examined whether adolescents show a similar spiral, and if so, whether coping self-efficacy—believing one can cope with stress—interrupts the spiral. Temporal dynamics of perceived stress, sleep quality, and coping self-efficacy were tracked in 381 9(th) graders (49% female, mean age 14.43, age range 14–16) using daily surveys across two school weeks (3184 observations). Though expected associations were evident between individuals, only a unidirectional path was found within individuals from sleep quality to perceived stress via coping self-efficacy. This challenges the conventional bidirectional understanding of sleep-stress relations and suggests coping self-efficacy as an intervention target.

Objective Chronic low back pain (CLBP) has a significant negative impact on daily functioning, particularly for those with challenges coping adaptively with ongoing pain. However, the dynamics of pain coping in daily life remain understudied. Therefore, we examined the extent to which pain intensity interferes with daily activities, and assessed whether pain coping strategies (as assessed using daily diaries) moderated this link. Method We analyzed diary data from a sample of 84 participants with CLBP who completed daily diaries for up to 30 days rating pain intensity, pain interference with daily activities, and their use of pain coping strategies, including pain rumination (i.e., repetitive thinking about the pain and its causes), reappraisal (i.e., evaluating one’s pain less negatively or more positively), and distraction (i.e., diverting attention from the pain). We hypothesized that these coping strategies would moderate the associations between pain and pain interference with daily activities, although in different directions. Results Results suggest that pain rumination strengthens the association between pain intensity and pain interference both on the person and day level, while pain reappraisal and distraction weaken this association, at the day and person levels, respectively. Conclusion Our findings suggest that those who are more preoccupied with their pain and those who are less likely to reappraise their pain have more pain interference with daily activities. These findings build on prior work on pain coping by using daily diaries and highlight two pain coping strategies that have particular relevance for reducing the impact of CLBP in daily life.

Background Poor sleep is common during pregnancy and is associated with increased risk of negative health outcomes. Research indicates that physical discomfort and having an active mind are primary factors for prenatal sleep disturbances. Mindfulness-based interventions have the potential for addressing these factors, but have yet to be optimized for this purpose in this population. Objective The objective of this study was to gather input from pregnant and postpartum individuals about the value of a mindfulness-based program for improving prenatal sleep and their preferred content and delivery format. Methods We conducted 2 focus groups with 12 pregnant people experiencing poor sleep quality and 3 individual interviews with postpartum people. Interviews were thematically analyzed. Results The majority of participants expressed strong interest in a mindfulness program for improving prenatal sleep. Participants reported that pregnancy-specific physical discomfort and worry (both general and pregnancy-specific) affected their sleep. Participants wanted sleep education, and strategies for calming the mind, reducing physical discomfort, reducing impact of bedtime partners on sleep, and tips for improving sleep schedule and quality. Participants recognized the convenience of an online intervention and the social benefits of an in-person intervention and favored a hybrid delivery model. Conclusion Addressing prenatal sleep problems is an unmet need. Given the challenges and discomfort women face during pregnancy, and the importance of adequate sleep for promoting mental and physical health during pregnancy, sleep difficulties are critical to address. A mindfulness-based intervention for improving prenatal sleep was deemed of high interest to this perinatal population.

Everyday experience suggests that sleep and affect are closely linked, with daytime affect influencing how we sleep, and sleep influencing subsequent affect. Yet empirical evidence for this bidirectional relationship between sleep and affect in non-clinical adult samples remains mixed, which may be due to heterogeneity in both construct definitions and measurement. This conceptual review proposes a granular framework that deconstructs sleep and affect findings according to three subordinate dimensions, namely domains (which are distinct for sleep and affect), methods (i.e., self-report vs. behavioral/physiological measures), and timescale (i.e., shorter vs. longer). We illustrate the value of our granular framework through a systematic review of empirical studies published in PubMed (N = 80 articles). We found that in some cases, particularly for sleep disturbances and sleep duration, our framework identified robust evidence for associations with affect that are separable by domain, method, and timescale. However, in most other cases, evidence was either inconclusive or too sparse, resulting in no clear patterns. Our review did not find support for granular bidirectionality between sleep and affect. We suggest a roadmap for future studies based on gaps identified by our review and discuss advantages and disadvantages of our granular dimensional framework.

Cognitive behavioral therapy for insomnia (CBT-I) is an effective, non-pharmacological intervention, designated by the American College of Physicians as the first-line treatment of insomnia disorder. The current randomized controlled study uses a Hybrid-Type-1 design to compare the effectiveness and implementation potential of two approaches to delivering CBT-I in primary care. One approach offers therapy to all patients through an automated, digital CBT-I program (ONLINE-ONLY). The other is a triaged STEPPED-CARE approach that uses a simple Decision Checklist to start patients in either digital or therapist-led treatment; patients making insufficient progress with digital treatment at 2 months are switched to therapist-led treatment. We will randomize 240 individuals (age 50 or older) with insomnia disorder to ONLINE-ONLY or STEPPED-CARE arms. The primary outcomes are insomnia severity and hypnotic medication use, assessed at baseline and at months 2, 4, 6, 9, and 12 after randomization. We hypothesize that STEPPED-CARE will be superior to ONLINE-ONLY in reducing insomnia severity and hypnotic use. We also aim to validate the Decision Checklist and explore moderators of outcome. Additionally, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will use mixed methods to obtain data on the potential for future dissemination and implementation of each approach. This triaged stepped-care approach has the potential to improve sleep, reduce use of hypnotic medications, promote safety, offer convenient access to treatment, and support dissemination of CBT-I to a large number of patients currently facing barriers to accessing treatment. Clinical trial registration:NCT03532282.

Background The COVID-19 pandemic has led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remain unknown. Objective Here, we present the framework and protocol for a novel feasibility, pilot study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. Methods The protocol details a 2-arm randomized controlled feasibility trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic were randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of cognitive behavioral therapy for insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0) and at weeks 1-6, 12, 28, and 56. Results The trial began enrollment on June 3, 2020 and closed enrollment on June 17, 2021. As of October 2021, 49 participants had been randomized to either immediate treatment or a 28-week waitlist; 23 participants were still active in the protocol. Conclusions To our knowledge, this protocol would represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 pandemic. The findings of this feasibility study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. Trial Registration ClinicalTrials.gov NCT04409743; https://clinicaltrials.gov/ct2/show/NCT04409743 International Registered Report Identifier (IRRID) DERR1-10.2196/34409

BACKGROUND The COVID-19 pandemic has led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remain unknown. OBJECTIVE Here, we present the framework and protocol for a novel feasibility, pilot study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a 2-arm randomized controlled feasibility trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic were randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of cognitive behavioral therapy for insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0) and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment on June 3, 2020 and closed enrollment on June 17, 2021. As of October 2021, 49 participants had been randomized to either immediate treatment or a 28-week waitlist; 23 participants were still active in the protocol. CONCLUSIONS To our knowledge, this protocol would represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 pandemic. The findings of this feasibility study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL ClinicalTrials.gov NCT04409743; https://clinicaltrials.gov/ct2/show/NCT04409743 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/34409

Introduction Sleep disorders are common in the military, and there is a gross shortage of sleep specialists in the military health system. The purposes of the present study were to (1) understand perceptions and expectations surrounding sleep telehealth approaches and (2) solicit feedback to optimize and refine a proposed novel sleep telehealth management platform. To accomplish these objectives, we investigated the perceptions, expectations, and preferences of active duty service members (ADSMs) with sleep disorders, primary care managers (PCMs), and administrative stakeholders regarding sleep telehealth management. Materials and Methods Using convenience sampling, we conducted five focus groups with 26 ADSMs and 11 individual interviews with PCMs from two military treatment facilities in the U.S National Capital Region and 11 individual interviews with administrative sleep stakeholders (9 military and 2 civilian). Results Active duty service members, PCMs, and administrative stakeholders provided insight regarding expectations for sleep telehealth as well as suggestions to optimize the novel sleep telehealth platform. In terms of outcomes, ADSMs expected sleep telehealth to improve sleep and convenience. Primary care managers expected improved sleep and other comorbidities, enhanced operational readiness, and reduced mortalities among their patients. Administrators expected increased access to care, optimized utilization of health services, realized cost savings, reduced accidents and errors, and improved military performance. In terms of the platform, for ADSMs, desired characteristics included delivery of timely clinical reports, improved patient–provider communication, and enhanced continuity of care. For PCMs and administrators,an ideal sleep telehealth solution will improve the diagnosis and triage of sleep patients, save PCM time, be easy to use, and integrate with the electronic health record system. Conclusion The proposed sleep telehealth platform appealed to nearly all participants as a significant force multiplier to enhance sleep disorder management in the military. Stakeholders offered valuable recommendations to optimize the platform to ensure its successful real-world implementation.

Introduction Comorbid depression often exacerbates dysfunctional beliefs about sleep in those with insomnia disorder. Anhedonia, a core symptom of depression, may be mechanistic in this association. Previous research suggests that, when appraising potential decisions, individuals with anhedonia regularly overestimate the probability of negatively valenced outcomes and underestimate the likelihood of positive outcomes. This study explores the relationship between anhedonia and sleep-related cognitions in patients with insomnia disorder. Methods Adults 50 years and older (N = 241) who met DSM-5 criteria for insomnia disorder were enrolled in a randomized controlled trial assessing the effectiveness of a stepped care approach to delivering Cognitive Behavioral Therapy for Insomnia. At baseline, participants completed the Dysfunctional Beliefs and Attitudes about Sleep Scale, Pre-Sleep Arousal Scale (cognitive subscale), Beliefs about Medications Questionnaire (Subscales assess the belief that hypnotics are necessary and concern regarding consequences of use), and PROMIS sleep-related impairment short form. A t-test was used to compare participants who did and did not endorse anhedonia on the Geriatric Depression Scale (GDS). We also correlated the Patient Health Questionnaire-4 (PHQ-4) anhedonia item with sleep-related cognition measures. Results Participants reporting anhedonia (GDS) endorsed greater dysfunctional beliefs about sleep (p < .001, d = 0.44) and sleep-related impairment (p < .01, d = 0.39). Groups did not differ significantly regarding belief in the necessity of sleep medications and concern with hypnotic use, nor in pre-sleep arousal. Higher anhedonia (PHQ-4) was correlated with more severe dysfunctional beliefs about sleep (r = .20, p < .01), belief in the necessity of hypnotics to manage sleep disturbance (r = .22, p < .001), and greater pre-sleep arousal (r = .18, p < .01). Conclusion Endorsement of anhedonia was associated with stronger dysfunctional beliefs about sleep in this sample of middle age and older adults with insomnia disorder. Participants reporting anhedonia also reported greater sleep-related impairment. Exploring anhedonia as a transdiagnostic symptom that influences interpretation of sleep-related difficulties may elucidate underlying mechanisms that sustain maladaptive cognitions. Prospective, multi-method studies will be essential to clarify predictive interactions between reward system dysfunction and sleep-related beliefs in those with insomnia disorder. Support (If Any) 1R01AG057500

Introduction Sleep hygiene and environment are important for adequate sleep quantity and quality. We examined two aspects of the sleep environment, individual behaviors and ambient factors, with nighttime sleep parameters in pregnant women with insomnia. Methods We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy for this cross-sectional analysis (n=70). Women completed a questionnaire assessing whether they regularly engaged in five individual behaviors in bed (yes/no) and how much their sleep was disrupted by seven ambient factors (scale from 1=not very much to 5=very much) and wore an Actiwatch 2 for a subsequent 7-day period. Responses of 4 or 5 for ambient factor items were categorized as ambient factors perceived to disrupt sleep. Generalized estimating equation regression models were used to estimate associations of individuals behaviors and ambient factors perceived to disrupt sleep with actigraphy-measured total nighttime sleep duration and sleep efficiency. Results The most commonly endorsed individual behaviors were using the internet/computer in bed (64%) and watching television in bed (43%), followed by talking on the phone in bed, listening to music in bed, and playing video/electronic games in bed (16-27%). Watching television in bed was associated with 23 fewer minutes of actigraphy-measured nighttime sleep (95% CI: -44, -1). No individual behavior was associated with actigraphy-measured sleep efficiency (all P>0.05). The most commonly endorsed ambient factors perceived to disrupt sleep were environmental noise (41%) and uncomfortable temperature (37%), followed by movement from others sharing the bed, having to take care of children in the middle of the night, someone else snoring, and light (24-29%). No ambient factors perceived to disrupt sleep were associated with actigraphy-measured nighttime sleep duration or efficiency (all P >0.05). Conclusion Individual behaviors and ambient factors perceived to disrupt sleep were common in pregnant women with insomnia. In this study, only watching television in bed was associated with objectively-measured nighttime sleep duration. Our findings suggest that future research could investigate potential interfering roles of arousal and cognitive factors contributing to insomnia during pregnancy. Support (If Any) National Institutes of Health (K99HD100585, R01NR013662)

Introduction Many sleep apnea patients suffer from comorbid insomnia disorder. Although cognitive behavioral insomnia therapy (CBTI) has proven effective for insomnia among such patients, access to trained CBTI providers remains limited. The current study is testing a digital CBTI (dCBTI) among PAP-prescribed sleep apnea patients with comorbid insomnia. Methods Patients enrolled in this trial complete baseline measures and are randomized to dCBTI or sleep hygiene (CTRL). After 8 weeks, all patients are reassessed. Patients in the dCBTI arm who reach remission by this time point are offered no additional insomnia treatment, whereas those who do not achieve insomnia remission are randomly assigned either another 8 weeks of dCBTI or a therapist delivered CBTI (TCBTI). All groups are reassessed at the end of this second 8-week treatment phase and then again at 3- and 6-month follow-ups. This report considers changes in scores on the Insomnia Severity Index (ISI) from baseline to the end of the second 8-week treatment, as well as insomnia remission (ISI < 8) and responder rates (> 8 point decline on the ISI) of dCBTI and TCBTI relative to the CTRL. The sample for this report included the first 305 participants (mean age = 56.5±12.5 yrs.; 57.1% females). Results Both dCBTI and TCBTI recipients showed greater (p = .0001) and comparable reductions in ISI scores from baseline to the end of the second 8-week treatment phase than did those in the CTRL group. Average ISI score improvements moved dCBTI and TCBTI recipients from moderately severe to mild insomnia symptoms. Significant group differences were noted for both the responder (X2 (2) =19.29, p < 0.0001) and remission rates (X2 (2) =13.89, p = 0.001). Responder rates for those participants switched to TCBTI (50%) were noteably higher than those continued with dCBTI (30.5%) and those in the CTRL group (19.2%); but remission rates were comparable (30.5% vs. 29.2%) and sigificantly higher than the rates shown by the CTRL group (19.2%). Conclusion The dCBTI tested compares well with TCBTI for reducing insomnia symptoms and achieving insomnia remission in those with insomnia and sleep apnea, but insomnia responder rates may be improved by switching patients to TCBTI. Support (If Any) Funding support from the National Heart, Lung and Blood Institute, Grant # 1R01HL130559-01A1.

Introduction Digital CBTI programs are effective at treating symptoms of insomnia. They also have the potential to increase treatment reach, convenience, and affordability for patients, and to reduce long wait times for behavioral sleep medicine providers. The COVID-19 pandemic has instigated an increased reliance on the use of technology for many. Thus, this study evaluates middle aged and older adults before and during the COVID-19 pandemic to assess: (1) differences in treatment modality preference (digital vs. therapist-led CBTI) and (2) sleep-related predictors of treatment modality preference. Methods Participants were older adults (N=229, 74% female, mean age=63.14) who were enrolled in the RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice (RESTING) study. At baseline, participants rated if they would prefer to access CBTI digitally or with a CBTI therapist, either in person or via telemedicine. After March 2020, in person was no longer listed as an option. Participants completed the Insomnia Severity Index (ISI) and a two-week sleep diary that allowed for an assessment of total sleep time (TST), sleep onset latency (SOL), and wake after sleep onset (WASO). Analyses compared responses to these items from participants completing assessments before March 2020 (Pre-Covid; n=74, 65% female, mean age=62.52) and after March 2020 (During-Covid; n=155, 78% female, mean age=63.44). Results Pre-Covid, 26% of participants preferred digital treatment, 47% of participants preferred a therapist-led intervention, and 27% did not express a preference. During-Covid, 35% of participants preferred digital treatment, 32% of participants preferred a therapist-led intervention, and 32% did not express a preference. This difference was statistically significant (c2=4.24, p=0.04). Responses were not significantly different between the first six months and the most recent six months of the pandemic (p=0.60). None of the sleep measures (ISI, TST, SOL, WASO) were associated with treatment modality preference in the full sample, Pre-Covid, or During-Covid. Conclusion The COVID-19 pandemic was associated with increased preference for digital CBTI among patients who are 50 and older, regardless of insomnia severity. Findings suggest that digital CBTI may be an acceptable treatment to many individuals with insomnia, thus increasing its dissemination potential. Support (If Any) R01AG057500 and T32MH019938

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 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

Objective Mindfulness-based interventions (MBI) have been shown to reduce subjective symptoms of insomnia but the effects on objective measures remain unclear. The purpose of this study was to examine sleep EEG microarchitecture patterns from a randomized controlled trial of Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Therapy for Insomnia (MBTI). Methods Sleep EEG spectral analysis was conducted on 36 participants with chronic insomnia (>6 months) randomized to 8-week MBSR, MBTI, or self-monitoring control (SM). Overnight polysomnography with 6-channel EEG was conducted at baseline, post-treatment, and 6-month follow-up. Spectral power averaged from channels C3/C4 across NREM epochs (excluding N1) was examined for within-group changes and relationships with self-report measures. Results Increases in absolute NREM beta (16–25 Hz) power were observed from baseline to post-treatment (p = .02, d = 0.53) and maintained at 6-month follow-up (p = .01, d = 0.57) in the combined MBI groups, and additionally in the gamma (25–40 Hz) range at follow-up for the MBTI group only. No significant changes in these frequency bands were observed for SM. Following mindfulness intervention, NREM beta was positively associated with Five-Facet Mindfulness (FFM) score (rho = 0.37, p = .091) and negatively associated with Insomnia Severity Index (rho = −0.43, p = .047). Conclusion These results in people with insomnia corroborate prior reports of increased high-frequency sleep EEG power associated with mindfulness training. This change in beta EEG pattern merits further evaluation as a potential marker of the effects of mindfulness meditation on sleep, especially given the paradoxical findings in the context of insomnia. Clinical Trial Registration clinicaltrials.gov , NCT00768781 .

OBJECTIVE:To evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.METHODS:Randomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial interventio

Study Objectives Insomnia Disorder diagnoses require persistent sleep complaints despite “adequate sleep opportunity.” Significant Perinatal Sleep Disruption makes this diagnosis challenging. This longitudinal study distinguished between Insomnia Disorder and Perinatal Sleep Disruption and their sleep and mental health correlates. Methods One hundred sixty-three nulliparous females (age M ± SD = 33.35 ± 3.42) participating in a randomized controlled trial repeated the Insomnia Disorder module of the Duke Structured Interview for Sleep Disorders and Patient-Reported Outcome Measurement Information System measures for sleep and mental health at 30- and 35-weeks’ gestation, and 1.5, 3, 6, 12, and 24 months postpartum (944 interviews, 1009 questionnaires completed). We compared clinical features when Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder criteria (without the Duration criterion) were: (1) met (Insomnia Disorder), (2) not met only because of the sleep opportunity criteria (Perinatal Sleep Disruption), and (3) not met due to other criteria (Low Complaint). Results Proportions of Insomnia Disorder were 16.0% and 19.8% during early and late third trimester, and ranged 5.3%–11.7% postpartum. If the sleep opportunity criteria were not considered, rates of Insomnia would be 2–4 times higher (21.4%–40.4%) across time-points. Mixed-effects models adjusting for covariates showed that compared to Low Complaint, both Insomnia Disorder and Perinatal Sleep Disruption scored significantly higher on insomnia and sleep disturbance scales, sleep effort, and sleep-related impairments (p values < .01), but depression and anxiety were comparable (p values > .12). Conclusion Assessing sleep complaints without considering sleep opportunities can result in over-diagnosis of Insomnia Disorder in the perinatal periods. Insomnia Disorder and Perinatal Sleep Disruption were both associated with adverse sleep and mood outcomes, and need to be carefully differentiated and appropriately addressed. Clinical Trial Registration: The SEED Project (Sleep, Eat, Emotions, and Development): A randomized controlled pilot study of a perinatal sleep intervention on sleep and wellbeing in mothers and infants. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371634, Australian New Zealand Clinical Trials Registry: ACTRN12616001462471.

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

Do people who have low-quality sleep tend to have more negative affect? This question is of great public interest, and many would assume the answer is “yes.” However, previous findings have been mixed, possibly due to differing measures of sleep and affect, or to a failure to separately examine negative affect reactivity and regulation. Across two studies, we assessed adults’ perceived sleep quality for at least two weeks and tested their negative affect reactivity and regulation in response to unpleasant pictures (Study 1) or painful thermal stimulation (Study 2) using both self-report and physiological measures. The relationships between perceived sleep quality, on the one hand, and negative affect reactivity and regulation, on the other, were non-significant. Furthermore, a Bayesian approach unanimously favored the null hypothesis. These results suggest that individual differences in perceived sleep quality may not predict negative affect reactivity or regulation across adult individuals.