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

Study Objectives: The 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. Methods: Ninety-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. Results: DSM-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. Conclusions: Insomnia 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.

Sleepless in COVID-19: racial disparities during the pandemic as a consequence of structural inequity.

STUDY OBJECTIVES: Insomnia has been on the rise during the 2019 coronavirus disease (COVID-19) pandemic, which may disproportionately affect racial minorities. This study characterized racial disparities in insomnia during the pandemic and evaluated mechanisms for such disparities. METHODS: Participants included 196 adults (48 Black) from a 2016-2017 clinical trial of insomnia treatment who were reevaluated in April 2020. Race was evaluated as a predictor of change in insomnia, impact of COVID-19, and COVID-19 stress. Mediation models using the PRODCLIN method evaluated the extent to which: (1) COVID-19 impact accounted for Black-White disparities in change in insomnia, and (2) COVID-19 stress accounted for associations between discrimination and change in insomnia. RESULTS: Increases in insomnia symptoms during COVID-19 were greater in Black compared to White participants, with 4.3 times the odds of severe insomnia (Insomnia Severity Index ≥ 22). Symptom severity was associated with pre-pandemic experiences of discrimination. Black participants were also disproportionately impacted by COVID-19, with twice the odds of irreparable loss of income/employment and four times the rate of COVID-19 diagnoses in their sociofamilial network compared to White participants. The disproportionate impact of COVID-19 accounted for 69.2% of the relationship between race and change in insomnia severity, and COVID-19 related stress accounted for 66.5% of the relationship between prior history of racial discrimination and change in insomnia severity. CONCLUSIONS: Black-White disparities in insomnia severity during COVID-19 may be driven by structural inequities resulting in the disproportionate impact of COVID-19 on Black Americans. Results lend support for the minority stress model in the context of sleep health. CLINICAL TRIAL REGISTRATION: Sleep to Prevent Evolving Affecting Disorders (SPREAD). NCT number: NCT02988375. https://clinicaltrials.gov/ct2/show/NCT02988375.

Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy.

OBJECTIVE: Insomnia affects over half of pregnant and postpartum women. Early evidence indicates that cognitive-behavioral therapy for insomnia (CBTI) improves maternal sleep and mood. However, standard CBTI may be less efficacious in perinatal women than the broader insomnia population. This study sought to identify patient characteristics in a perinatal sample associated with poor response to CBTI, and characterize patient feedback to identify areas of insomnia therapy to tailor for the perinatal experience. PARTICIPANTS: Secondary analysis of 46 pregnant women with insomnia symptoms who were treated with digital CBTI in a randomized controlled trial. METHODS: We assessed insomnia, cognitive arousal, and depression before and after prenatal treatment, then 6 weeks postpartum. Patients provided feedback on digital CBTI. RESULTS: Residual cognitive arousal after treatment was the most robust factor associated with treatment non-response. Critically, CBTI responders and non-responders differed on no other sociodemographic or pretreatment metrics. After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality. Patient feedback indicated that most patients preferred online treatment to in-person treatment. Although women described digital CBTI as convenient and helpful, many patients indicated that insomnia therapy would be improved if it addressed sleep challenges unique to pregnancy and postpartum. Patients requested education on maternal and infant sleep, flexibility in behavioral sleep strategies, and guidance to manage infant sleep. CONCLUSIONS: Modifying insomnia therapy to better alleviate refractory cognitive arousal and address the changing needs of women as they progress through pregnancy and early parenting may increase efficacy for perinatal insomnia.Name: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum DepressionURL: clinicaltrials.govRegistration: NCT03596879.

Self-efficacy in Insomnia Symptom Management after Digital CBT-I Mediates Insomnia Severity during the COVID-19 Pandemic.

STUDY OBJECTIVES: Digital cognitive behavioral therapy for insomnia (dCBT-I) can reduce acute insomnia and depressive symptoms and prevent symptom recurrence. The current study evaluated self-efficacy in managing insomnia symptoms as a potential mediator of the relationship between prior dCBT-I and subsequent insomnia and depressive symptoms assessed during the coronavirus 2019 (COVID-19) pandemic. METHOD: Participants were 208 adults who completed a randomized controlled trial of dCBT-I versus sleep education in 2016-2017 and also completed self-report assessments of insomnia, depression, and self-efficacy in managing insomnia symptoms. Data were collected in May 2020, five weeks into state-wide COVID-19 stay-at-home orders. Regression and mediation analyses were used to evaluate the extent to which self-efficacy accounted for the relationship between treatment condition and improvement in insomnia and depressive symptoms from pre-treatment to COVID-19 follow-up. RESULTS: Prior dCBT-I predicted greater self-efficacy in managing insomnia symptoms. Self-efficacy accounted for 49% and 67% of the protective effect of dCBT-I against COVID-era insomnia and depressive symptoms, respectively. CONCLUSIONS: This study affirms the importance of self-efficacy as a key intervention outcome and potential mechanism by which dCBT-I predicts future sleep and mental health. Future studies that evaluate the role of self-efficacy in treatment effectiveness and resilience can provide additional clues about how to optimize dCBT-I for maximum benefit to public health.

Predicting circadian misalignment with wearable technology: validation of wrist-worn actigraphy and photometry in night shift workers.

STUDY OBJECTIVES: A critical barrier to successful treatment of circadian misalignment in shift workers is determining circadian phase in a clinical or field setting. Light and movement data collected passively from wrist actigraphy can generate predictions of circadian phase via mathematical models; however, these models have largely been tested in non-shift working adults. This study tested the feasibility and accuracy of actigraphy in predicting dim light melatonin onset (DLMO) in fixed night shift workers. METHODS: A sample of 45 night shift workers wore wrist actigraphs before completing DLMO in the laboratory (17.0 days ± 10.3 SD). DLMO was assessed via 24 hourly saliva samples in dim light (<10 lux). Data from actigraphy were provided as input to a mathematical model to generate predictions of circadian phase. Agreement was assessed and compared to average sleep timing on non-workdays as a proxy of DLMO. Model code and an open-source prototype assessment tool are available (www.predictDLMO.com). RESULTS: Model predictions of DLMO showed good concordance with in-lab DLMO, with Lin's concordance coefficient of 0.70, which was twice as high as agreement using average sleep timing as a proxy of DLMO. The absolute mean error of the predictions was 2.88 h, with 76% and 91% of the predictions falling with 2 and 4 h, respectively. CONCLUSION: This study is the first to demonstrate the use of wrist actigraphy-based estimates of circadian phase as a clinically useful and valid alternative to in-lab measurement of DLMO in fixed night shift workers. Future research should explore how additional predictors may impact accuracy.

Racial discrimination as a mediator of racial disparities in insomnia disorder.

STUDY OBJECTIVES: Racial and ethnic minorities are more likely to suffer from insomnia that is more severe; however, few studies have examined mechanisms by which racial disparities in severity of insomnia disorder may arise. One potential mechanism for disparities in insomnia severity is perceived discrimination. This study tested discrimination as a mediator in the relationship between race and insomnia. METHODS: Participants were recruited from communities in the Detroit metropolitan area and were diagnosed with insomnia disorder using the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). The final sample included 1,458 individuals. Insomnia symptom severity was assessed via the Insomnia Severity Index and self-reported racial discrimination was evaluated using a single item. Racial discrimination was tested as a mediator in the relationship between race and insomnia symptom severity. Individuals were categroized as either White or a racial minority (i.e., non White individuals), with sensitivity analyses examining Black individuals and non-Black racial minority groups. RESULTS: Consistent with our hypothesis, racial discrimination was a significant mediator accounting for 57.3% of the relationship between race and insomnia symptom severity. Sensitivity analyses indicated that the indirect effect of racial discrimination was stronger in the non-Black racial minority group compared to Black individuals. CONCLUSIONS: These results provide support that racial discrimination is likely an important mechanism by which racial and ethnic sleep disparities exist. Implications for prevention, intervention, and treatment of insomnia in racial minorities to reduce health disparities are discussed.

A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.

OBJECTIVE: Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia. METHODS: Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth. RESULTS: From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed. CONCLUSIONS: Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.

Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial.

STUDY OBJECTIVES: Sleep restriction therapy (SRT) has been shown to be comparably effective relative to cognitive behavioral therapy for insomnia (CBT-I), but with lower requirements for patient contact. As such, SRT appears to be a viable alternate treatment for those who cannot complete a full course of CBT-I. However, it is unclear whether SRT-a treatment solely focusing on restricting time in bed-increases risk for sleepiness comparably to CBT-I. The current study tested objective sleepiness as an outcome in a randomized controlled trial comparing SRT, CBT-I, and attention control in a sample of postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. METHODS: Single-site, randomized controlled trial. A total of 150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder were randomized to 3 treatment conditions: sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions). Blinded assessments were performed at pretreatment and posttreatment. Risk of excessive sleepiness was evaluated using a symmetry analysis of sleepiness measured through the Multiple Sleep Latency Test (MSLT). RESULTS: The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy. This suggests that excessive sleepiness is not of unique concern following SRT relative to CBT-I or sleep education. CONCLUSIONS: SRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I. Future research should characterize objective measures of excessive sleepiness immediately following sleep restriction. CLINICAL TRAIL REGISTRATION: Registry: ClinicalTrials.gov; Name: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295.

Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?

STUDY OBJECTIVES: The safety profile of the dual orexin receptor antagonists (DORAs) are currently unknown with regard to nocturnal responsivity among people with insomnia. We compared the auditory awakening thresholds (AATs) of the DORA suvorexant (10 and 20 mg) versus placebo in 12 individuals with DSM-5 insomnia. METHODS: The study used a double-blind, placebo-controlled, three-way crossover design. Participants were randomly assigned to a treatment sequence that included placebo, suvorexant 10 mg, and suvorexant 20 mg. At the time of maximum drug concentration, auditory tones were played during stable stage N2 sleep. Tones increased by 5-decibel (db) increments until the participant awakened. The db at awakening was recorded as the AAT and compared between conditions. The proportion of awakenings higher than 85 db was also compared between conditions. Finally, sensitivity analyses were also conducted using surrounding thresholds (80 db and 90 db). RESULTS: The mean AAT did not differ significantly between either dose of suvorexant compared to placebo. Moreover, the proportions of individuals who remained asleep at the AAT 85 db cutoff did not differ across conditions. In addition, wake after sleep onset decreased and total sleep time increased in the suvorexant 20 mg condition compared to placebo. CONCLUSIONS: Suvorexant (10 and 20 mg) preserved the ability to respond to nocturnal stimuli, whereas the 20-mg dose improved the sleep of people with insomnia. This suggests that DORAs such as suvorexant can effectively treat insomnia while allowing patients to awaken to nocturnal stimuli in the environment. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs; Identifier NCT03312517; URL: https://clinicaltrials.gov/ct2/show/NCT03312517. CITATION: Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, SinghM, Tonnu CV, Fellman-Couture C. Can the orexin antagonist suvorexant preserve the ability to awaken to auditory stimuli while improving sleep? J Clin Sleep Med. 2019;15(9):1285-1291.

Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.

STUDY OBJECTIVES: Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious. METHODS: Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up. RESULTS: CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment. CONCLUSIONS: CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.

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

Study Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Hyperarousal and sleep reactivity in insomnia: current insights.

Hyperarousal is a key component in all modern etiological models of insomnia disorder. Overall patterns in the literature suggest that over-active neurobiological and psychological systems contribute to difficulty sleeping. Even so, mixed results regarding the specific mechanisms linking hyperarousal to sleep disturbance limit current etiological conceptualizations. Similar basal arousal profiles between individuals with high vs low risk for insomnia in the absence of stress exposure suggest that dysregulated stress "response" rather than general hyperarousal may be a more pertinent marker of risk. In this report, we discuss evidence for hyperarousal in insomnia and explore the role of sleep reactivity. A trait characteristic, sleep reactivity is the degree to which stress disrupts sleep, manifesting as difficulty falling and staying asleep. Premorbid sleep reactivity has been shown to identify individuals at risk for future insomnia disorder, such as highly reactive sleepers (whose sleep systems are sensitive to stress) who are at elevated disease risk. Research points to genetics, family history of insomnia, gender, and environmental stress as factors that influence sleep reactivity. Importantly, stress-related cognitive-emotional reactivity (e.g., rumination, worry) may exploit the vulnerability of a highly reactive sleep system. We propose that sleep reactivity and cognitive-emotional reactivity may share a bidirectional relationship, conferring an insalubrious environment for sleep in response to stress. Future research on sleep reactivity is needed to identify its neurobiology, characterize its relationship with cognitive-emotional reactivity, and explore the potential clinical utility of sleep reactivity in treatment planning.