Sleep medicine

1. Patient perspectives on facilitators and barriers to equitable engagement with digital CBT-I

   STUDY OBJECTIVES: Digital cognitive behavioral therapy for insomnia has significant advantages for dissemination and scalability vs. in-person cognitive behavioral therapy for insomnia and is, therefore, well-positioned to be the first-line intervention for insomnia. However, only about half of patients remit following digital cognitive behavioral therapy for insomnia. Evidence suggests that treatment engagement is a critical driver of digital cognitive behavioral therapy for insomnia effectiveness, and barriers to engagement disproportionately impact people from under-resourced communities. For digital cognitive behavioral therapy for insomnia to be effective and scalable, we need to identify facilitators and barriers to digital cognitive behavioral therapy for insomnia engagement.

   METHODS: Responses from an exit survey about participant experiences with digital cognitive behavioral therapy for insomnia were analyzed using mixed methods. The survey included quantitative measures of treatment engagement and a free-response item, which was coded and analyzed for themes using both inductive and deductive approaches.

   RESULTS: Analyses revealed five themes that were relevant for engagement: (1) digital person-to-person components, (2) type and extent of information, (3) user's sense of autonomy, (4) app functionality, and (5) importance of tailored content. Facilitators included enjoyment of digital cognitive behavioral therapy for insomnia elements, particularly those that enhanced a sense of connection (eg, a digital therapist avatar); content presented clearly and at an appropriate pace; and smooth app functionality. Barriers included desire for additional human support, perception that digital cognitive behavioral therapy for insomnia did not account for clinical complexities, and factors that interfered with implementation of key treatment recommendations.

   CONCLUSION: Many barriers and facilitators are influenced by health literacy and technological literacy. Those with access to health and technological literacy are better equipped to engage with digital cognitive behavioral therapy for insomnia. Recommendations for adaptations and enhancements are discussed.

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

   OBJECTIVES: Combining mindfulness with behavioral sleep strategies has been found to alleviate symptoms of insomnia and depression during pregnancy, but mechanisms for this treatment approach remain unclear. The present study examined nocturnal cognitive arousal and sleep effort as potential treatment mechanisms for alleviating insomnia and depression via a mindfulness sleep program for pregnant women.

   METHODS: Secondary analysis from a proof-of-concept trial of 12 pregnant women with DSM-5 insomnia disorder who were treated with Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness framework. Data were collected across eight weekly assessments: pretreatment, six sessions, and posttreatment. Measures included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC), and the Glasgow sleep effort scale (GSES). We used linear mixed modeling to test cognitive arousal and sleep effort as concurrent and prospective predictors of insomnia and depression.

   RESULTS: Most patients reported high cognitive arousal before PUMAS (75.0%), which decreased to 8.3% after treatment. All insomnia remitters reported low cognitive arousal after treatment, whereas half of nonremitters continued reporting high cognitive arousal. Both nocturnal cognitive arousal and sleep effort were associated with same-week changes in insomnia throughout treatment, and sleep effort yielded a prospective effect on insomnia. Lower levels of nocturnal cognitive arousal and sleep effort prospectively predicted reductions in depression.

   CONCLUSIONS: The present study offers preliminary evidence that reducing sleep effort and nocturnal cognitive arousal may serve as key mechanisms for alleviating insomnia and depression via mindfulness-based insomnia therapy. ClinicalTrials.gov ID: NCT04443959.

3. Epworth sleepiness scale: A meta-analytic study on the internal consistency

   OBJECTIVE/BACKGROUND: The Epworth Sleepiness Scale (ESS) is one of the most used self-reported instruments to assess sleepiness. Thus, several adaptations into different Languages have been performed worldwide over the years. The scale has produced disparate psychometric properties when applied in different settings. In the current study, our aim was to perform a Reliability Generalization meta-analysis of the Cronbach᾽s alphas of all published studies on ESS, specifically with a psychometric focus.

   PATIENTS/METHODS: Three reference databases (Scopus, PubMed and Web of Science) were searched since 1991 to October 2022 and all the records on psychometric or validation studies that reported Cronbach's alphas, from clinical and nonclinical groups, were included. In total, data from 46 publications (63 estimates) were extracted, comprising 92,503 participants.

   RESULTS: Using a Random-Effects Model, the cumulative Cronbach's alpha for the 63 estimates was about 0.82 (CI: 0.798, 0.832) which can be considered as a good measure. However, and as expected, it was observed a high level of heterogeneity (I(2) = 98.96%). Moderation analyses considering setting, date, continent, risk of bias, sex, age and language were performed in order to account for the heterogeneity. Even so, only the variables study setting and continent were significant, and had little importance in explaining the heterogeneity.

   CONCLUSIONS: The ESS is a reliable tool to measure sleepiness; however, further studies are needed to investigate what variables might explain the observed variability. Moreover, it will be important to include empirical studies beyond psychometric ones.

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

   OBJECTIVES: Cognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal.

   METHODS: A single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n = 5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale.

   RESULTS: Eleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen's dz = 3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen's dz = 2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen's dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components.

   CONCLUSION: Prenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression.

   GOV ID: NCT04443959.

5. 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.