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Abstract Study Objectives Insomnia and obstructive sleep apnea (OSA) commonly co-occur which makes OSA difficult to treat with continuous positive airway pressure (CPAP). We conducted a randomized controlled trial in participants with OSA and co-occurring insomnia to test the hypothesis that initial treatment with cognitive and behavioral therapy for insomnia (CBT-i), versus treatment as usual (TAU) would improve insomnia symptoms and increase subsequent acceptance and use of CPAP. Methods One hundred and forty-five participants with OSA (apnea-hypopnea index ≥ 15) and comorbid insomnia were randomized to either four sessions of CBT-i, or TAU, before commencing CPAP therapy until 6 months post-randomization. Primary between-group outcomes included objective average CPAP adherence and changes in objective sleep efficiency by 6 months. Secondary between-group outcomes included rates of immediate CPAP acceptance/rejection, and changes in; sleep parameters, insomnia severity, and daytime impairments by 6 months. Results Compared to TAU, participants in the CBT-i group had 61 min greater average nightly adherence to CPAP (95% confidence interval [CI] = 9 to 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99% vs. 89%; p = 0.034). The CBT-i group showed greater improvement of global insomnia severity, and dysfunctional sleep-related cognitions by 6 months (both: p < 0.001), and greater improvement in sleep impairment measures immediately following CBT-i. There were no between-group differences in sleep outcomes, or daytime impairments by 6 months. Conclusions In OSA participants with comorbid insomnia, CBT-i prior to initiating CPAP treatment improves CPAP use and insomnia symptoms compared to commencing CPAP without CBT-i. OSA patients should be evaluated for co-occurring insomnia and considered for CBT-i before commencing CPAP therapy. Clinical Trial Treating comorbid insomnia with obstructive sleep apnea (COMSIA) study: A new treatment strategy for patients with combined insomnia and sleep apnea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.

Insomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period. Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up. At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition. dCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention. Sleep to Prevent Evolving Affective Disorders; NCT02988375.

Abstract Study Objectives Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use. Methods 125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a “sleep coach” (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected. Results Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (−3.2 and −1.7), SOL-D (−16.2 and −15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05). Conclusions An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA. Trial Registration ClinicalTrials.gov Study name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans URL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist= Registration: NCT02027558

In this phase 2 randomized, placebo-controlled trial involving 112 participants with narcolepsy type 1, oveporexton significantly improved measures of wakefulness, sleepiness, and cataplexy over a period of 8 weeks.

Abstract Study Objectives Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. Methods COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016–2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic. Results Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition. Conclusions Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic. Clinical Trial Registration NCT02988375

Abstract Study Objectives To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia. Methods 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI <5), remission (ISI <8), and response (ISI reduction from baseline >7) serving as the clinical endpoints. Results No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure. Conclusions The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.

Abstract 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.

Abstract Study Objectives While cognitive and behavioral therapy for insomnia (CBTi) is an effective treatment in patients with comorbid moderate and severe obstructive sleep apnea (OSA), there is concern that the bedtime restriction component of CBTi might dangerously exacerbate daytime sleepiness in such patients. We examined randomized controlled trial data to investigate the effect of OSA severity, and pretreatment daytime sleepiness on week-to-week changes in daytime sleepiness and sleep parameters during CBTi and no-treatment control. Methods One hundred and forty-five patients with untreated physician-diagnosed OSA (apnea–hypopnea index ≥15) and psychologist-diagnosed insomnia (ICSD-3) were randomized to a 4-week CBTi program (n = 72) or no-treatment control (n = 73). The Epworth sleepiness scale (ESS) and sleep diaries were completed during pretreatment, weekly CBTi sessions, and posttreatment. Effects of OSA severity, pretreatment daytime sleepiness, and intervention group on weekly changes in daytime sleepiness and sleep parameters were investigated. Results The CBTi group reported a 15% increase in ESS scores following the first week of bedtime restriction (M change = 1.3 points, 95% CI = 0.1–2.5, p = 0.031, Cohen’s d = 0.27) which immediately returned to pretreatment levels for all subsequent weeks, while sleep parameters gradually improved throughout CBTi. There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups or OSA-severity groups. Higher pretreatment ESS scores were associated with a greater ESS reduction during CBTi. Conclusions CBTi appears to be a safe and effective treatment in the presence of comorbid moderate and severe OSA. Nevertheless, patients living with comorbid insomnia and sleep apnea and treated with CBTi should be monitored closely for increased daytime sleepiness during the initial weeks of bedtime restriction therapy. Clinical Trial Registration Treating comorbid insomnia with obstructive sleep apnoea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.

Abstract Study Objectives To compare the efficacy of cognitive behavioral therapy for insomnia (CBTi) disorder and a Control condition on reducing insomnia and comorbid symptoms in a sample of active duty military personnel. Methods Randomized clinical trial of 151 active duty US Army personnel at Fort Hood, Texas. Results This study replicated Original (n = 66) findings (CBTi outperformed Control) in a follow-on sample (n = 85) on diary-assessed sleep efficiency (d = 1.04), total sleep time (d = 0.38), sleep latency (d = −0.93), number of awakenings (d = −0.56), wake time after sleep onset (d = −0.91), sleep quality (d = 1.00), and the Insomnia Severity Index (d = −1.36) in active duty soldiers. CBTi also outperformed Control in the combined sample (N = 151) on four of the five subscales of the Multidimensional Fatigue Inventory (d = −0.32 to −0.96) and the mental health subscale on the Veterans RAND 12-Item Health Survey (d = 0.37). Exploratory analyses also showed CBTi outperformed Control on nicotine (d = −0.22) and caffeine (d = −0.47) use reduction. Significant within-group differences were found for both groups on depression, anxiety, and posttraumatic stress disorder symptoms, but there was no group by time interaction for these symptoms or for use of hypnotics or alcohol. Conclusions CBTi was an effective treatment for insomnia and comorbid symptoms including daytime fatigue, general mental health, nicotine, and caffeine use. Clinical Trial Registration Clinicaltrials.gov; Identifier: NCT01549899; “Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia”

Abstract Study Objectives: Lost productivity caused by insomnia is a common and costly problem for employers. Although evidence for the efficacy of Internet-based cognitive behavioral therapy for insomnia (iCBT-I) already exists, little is known about its economic effects. This study aims to evaluate the cost-effectiveness and cost-benefit of providing iCBT-I to symptomatic employees from the employer's perspective. Methods: School teachers (N = 128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a waitlist-control-group, both with access to treatment as usual. Economic data were collected at baseline and 6-mo follow-up. We conducted (1) a cost-effectiveness analysis with treatment response (Reliable Change [decline of 5.01 points] and Insomnia Severity Index < 8 at 6-month follow-up) as the outcome and (2) a cost-benefit analysis. Because both analyses were performed from the employer's perspective, we focused specifically on absenteeism and presenteeism costs. Statistical uncertainty was estimated using bootstrapping. Results: Assuming intervention costs of €200 ($245), cost-effectiveness analyses showed that at a willingness-to-pay of €0 for each positive treatment response, there is an 87% probability that the intervention is more cost effective than treatment as usual alone. Cost-benefit analyses led to a net benefit of €418 (95% confidence interval: −593.03 to 1,488.70) ($512) per participant and a return on investment of 208% (95% confidence interval: −296.52 to 744.35). The reduction in costs was mainly driven by the effects of the intervention on presenteeism and to a lesser degree by reduced absenteeism. Conclusions: Focusing on sleep improvement using iCBT-I may be a cost-effective strategy in occupational health care. Clinical Trials Registration: Title: Online Recovery Training for Better Sleep in Teachers with High Psychological Strain. German Clinical Trial Register (DRKS), URL: https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004700. Identifier: DRKS00004700. Commentary: A commentary on this article appears in this issue on page 1767.