Protocol of a randomized controlled trial into guided internet-delivered cognitive behavioral therapy for insomnia in autistic adults (i-Sleep Autism).

BACKGROUND: Sleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population. METHODS: With this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (N = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators. CONCLUSION: This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention. TRIAL REGISTRATION: NL-OMON56692.

Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: results from the real-world DREAM study.

Introduction: Chronic insomnia is a substantial public health burden that often presents with co-occurring depression and anxiety. Randomized clinical trials and preliminary real-world evidence have shown that digitally delivered cognitive-behavioral therapy for insomnia (dCBT-I) is associated with improvements in insomnia, but real-world evidence is needed to determine the true impact of digital CBT-I. This pragmatic study aimed to evaluate the benefits of treating chronic insomnia with a tailored prescription digital therapeutic in a real-world population. Methods: This prospective, single-arm clinical study involved adults aged 22-75 with chronic insomnia living in the US who had access to a mobile device. Participants accessed the FDA-cleared prescription digital therapeutic (PDT; Somryst®) over a 9-week intervention period. The PDT delivers cognitive-behavioral therapy for insomnia via six interactive treatment cores and daily sleep diaries used for tailoring treatment. Participants completed validated patient-reported instruments at baseline, before completing treatment cores, immediately post-intervention, and at 6-month and 1-year follow-ups. The Insomnia Severity Index [ISI], the 8-item Patient Health Questionnaire [PHQ-8], and the Generalized Anxiety Disorder-7 scale [GAD-7] were used to determine the effect of the PDT on insomnia, depression, and anxiety. Results: After screening, 1565 adults accessed the PDT. 58% of those who began the program completed Core 4, established as exposure to all mechanisms of action in the digital therapeutic. For those who completed assessments for all 6 cores (48.4%), the ISI was lowered from 18.8 to a mean of 9.9 (P <.001). These scores continued to be lower than baseline at immediate post (11.0), 6-month (11.6), and 1-year follow-ups (12.2) (P <.001). The results of the PHQ-8 and GAD-7 also show significant decreases at all measured timepoints from baseline (P <.001). Of the patients that began the program, 908 (58.0%) were considered adherent and 733 (46.8%) completed all 6 cores. Conclusion: Data from the DREAM study contributes to the growing body of clinical evidence of how patients are utilizing a PDT in the real world, outside of controlled settings, offering insights for clinicians who use these therapeutics in practice. Clinical trial registration: ClinicalTrials.gov, identifier NCT04325464.

From guidelines to bedside - insomnia treatment practices in South Korea: a nationwide cohort study.

Background: Insomnia is a prevalent disorder that impacts quality of life and leads to significant economic costs. Treatment includes both non-medication and pharmacological interventions, with international guidelines recommending cognitive behavioral therapy for insomnia (CBT-I) as the first-line treatment. Objective: To describe current insomnia treatment practices in South Korea, focusing on pharmacological and non-medication treatments, and to identify gaps in guideline implementation. Methods: This cohort study used data from the Korea National Health Insurance Service-National Sample Cohort (NHIS-NSC) from 2002 to 2019 and identified 18,003 patients newly diagnosed with insomnia between 2015 and 2019. This study analyzed treatment patterns and utilization rates. Results: Of the 18,003 patients, 16,181 (89.9%) received pharmacological treatment, resulting in 35,638 prescriptions. Zolpidem (60%) and benzodiazepines (30-40%) were the most prescribed medications. Most patients were treated in clinics, with consistent dosages and increasing treatment lengths. Psychotherapy claims rose from 3.20% in 2015 to 9.14% in 2019, particularly in general hospitals (22.06% to 48.37%), but remained low in clinics (1.26% to 2.08%). Conclusion: Pharmacological treatments dominate insomnia management in South Korea, with CBT-I being underutilized. Future efforts should focus on integrating non-pharmacological treatment into routine practice and exploring treatment risks and effectiveness based on patient demographics.

Analysis of the Improvement Sequence in Insomnia Symptoms and Factors Influencing the Treatment Outcomes of Smartphone-Delivered CBT in Patients with Insomnia Disorder.

Background: The effectiveness of medication combined with smartphone-delivered cognitive behavioral therapy for insomnia (CBT-I) has been well verified, but there are few studies on the sequence of remission of insomnia symptoms. This study aims to understand the sequence of symptom improvement and the factors influencing the treatment effectiveness in patients with insomnia. Methods: Smartphone-delivered CBT, as a form of Online CBT, allows for training through mobile devices at any time and place. We utilized the Good Sleep 365 app to conduct a survey, involving 2820 patients who met the baseline inclusion criteria. These patients were assessed using a general demographic questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to evaluate general demographic information and insomnia symptoms, and subsequently underwent CBT training using the Good Sleep 365 app. A total of 1179 patients completed follow-ups at 4 weeks, 8 weeks, 16 weeks, and 24 weeks. Results: At 4 weeks and 8 weeks, the descending order of the reduction rates of PSQI components (excluding component 6: use of sleeping medication) was: sleep latency, subjective sleep quality, sleep efficiency, sleep disturbance, sleep maintenance, and daytime dysfunction. At 16 weeks and 24 weeks, the descending order was subjective sleep quality, sleep latency, sleep efficiency, daytime dysfunction, sleep maintenance, and sleep disturbance. There were significant differences in the reduction rates of PSQI components (excluding component 6: use of sleeping medication) both at the same follow-up times and at different follow-up times (all P<0.05). Multivariable logistic regression analysis showed that patients older than 30 years and those with a college degree or above had better treatment outcomes, whereas those with a disease duration of more than three years had worse outcomes. Conclusion: The sequence of symptom improvement in patients with insomnia changes over time, and age, educational level, and duration of disease are factors influencing treatment outcomes.

Effectiveness of a guided digital self-help intervention to improve sleep and the biological clock in university students - Study protocol for a randomized controlled trial.

Background: Sleep problems occur in many university students which affects their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBT-I) has been proven effective in adults but research in university students, who struggle to maintain a 24-hour rhythm, is still limited. We hypothesize that a guided digital CBT-I intervention, enriched with components on the biological clock ('i-Sleep & BioClock') will be effective in reducing insomnia severity and improving mental health outcomes for students with sleep problems. Objectives: We aim to evaluate the effectiveness of a guided online sleep and biological clock self-help intervention in improving sleep, depression symptoms, anxiety symptoms, functioning, academic performance, and quality of life in university students at 6 weeks and 18 weeks. Methods: This is a two-arm parallel-group superiority randomized controlled trial, comparing a 5-week guided online 'i-Sleep & BioClock' intervention to online psychoeducation (PE). We aim to include 192 university students (Bachelor, Master, and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥10), aged ≥16, who can speak Dutch or English. We are excluding students with current risk for suicide or night shifts. The primary outcome is insomnia severity. Secondary outcomes include sleep estimates (sleep and light exposure diary), depression, anxiety, functioning, quality of life, and academic performance. The effectiveness of the intervention compared to online PE will be evaluated using linear mixed models. Discussion: The current study tests the effectiveness of an online self-help intervention for university students who suffer from sleep problems. This trial builds upon an open feasibility study and will provide evidence of an online guided self-help program for students. The findings of this study will determine the potential wider dissemination of the intervention to address the high need for available and accessible help for students experiencing insomnia. Trial registration: ClinicalTrials.Gov (NCT06023693), registered on August 3rd, 2023.

One-week inpatient cognitive behavioral therapy for insomnia: a retrospective study.

Objective: To examine the effectiveness of one-week inpatient cognitive behavioral therapy for insomnia (CBT-I) in patients without severe mental disorders in the real-world setting to answer the research question "Can inpatient CBT-I be abbreviated?". Methods: In this retrospective, single-group, pretest-posttest study, the clinical outcome data of 94 patients who underwent one-week inpatient CBT-I were collected. Self-report scale scores and hypnotic medication use were obtained at baseline and at the 3-month follow-up after therapy. Results: CBT-I significantly improved insomnia severity (Z = -7.65, P < 0.001, Cohen's d = 1.34), anxiety (Z = -6.23, P < 0.001, Cohen's d = 1.02), depression (Z = -6.42, P < 0.001, Cohen's d = 1.06), daytime sleepiness (Z = -2.40, P = 0.016, Cohen's d = 0.35), and fatigue severity (Z = -5.54, P < 0.001, Cohen's d = 0.88) and reduced hypnotic medication use (χ2 = 33.62, P < 0.001). At the follow-up assessment, 58 patients (67.4%) had clinically meaningful changes in insomnia, and 51 patients (59.3%) met the criteria for insomnia remission. Conclusion: The results of this preliminary study imply that one-week inpatient CBT-I may be an effective intervention for the treatment of insomnia in patients without severe mental disorders.

Digital cognitive behavioural therapy for insomnia versus digital sleep education control in an Australian community-based sample: a randomised controlled trial.

BACKGROUND: Insomnia is a prevalent condition in Australia that increases the risk of depression and anxiety symptoms. Cognitive behaviour therapy for insomnia (CBT-i) is the recommended 'first line' treatment but is accessed by a minority of people with insomnia. AIMS: To improve CBT-i access in Australia, we aimed to develop and test a self-guided interactive digital CBT-i program. METHODS: An online randomised controlled trial was conducted from August 2022 to August 2023 to investigate the effect of digital CBT-i, versus digital sleep education control, on symptoms of insomnia (ISI), depression (PHQ-9), anxiety (GAD-7), fatigue, sleepiness and maladaptive beliefs about sleep at 8-week follow-up. The control group accessed the intervention after the 8-week follow-up. Questionnaires were additionally administered at 16 and 24 weeks. Intent-to-treat mixed models and complete-case chi-squared analyses were used. RESULTS: Participants included 62 adults with insomnia symptoms (age M (SD) = 52.5 (16.3), 82% female, ISI = 18.6 (2.9)). There were no between-group differences in baseline characteristics or missing 8-week data (14.5%). After adjusting for baseline scores, CBT-i was associated with lower insomnia (Diffadj (95% CI) = 7.32 (5.0-9.6), P < 0.001, d = 1.64), depression (3.36 (1.3-5.4), p = 0.002, d = 0.84), fatigue (5.2 (2.5-7.9), P < 0.001, d = 1.00) and maladaptive beliefs about sleep (11.0 (4.1-18.0), P = 0.002, d = 0.82), but not anxiety symptoms at 8 weeks (1.84 (-0.1 to 3.8), p = 0.060, d = 0.50). Compared to control, CBT-i was associated with greater rates of insomnia remission (ISI <8; 0.0%, vs 40.0%, P < 0.001) and response at 8 weeks (ISI reduction ≥6; 7.1% vs 72.0%, P < 0.001). Improvements in insomnia and depression were maintained at 24 weeks in the CBT-i group. CONCLUSIONS: This interactive digital CBT-i program resulted in large and sustained improvements in symptoms of insomnia, depression, fatigue and maladaptive beliefs about sleep in Australian adults with insomnia symptoms. Implementation programs are required to increase digital CBT-i access and uptake.

How sleep in patients with serious mental illness is recorded and treated, and its impact on service engagement.

BACKGROUND: Sleep and mental health share a bidirectional relationship whereby problems in one exacerbate the other. Accordingly, sleep problems are frequent and severe in serious mental illness (SMI) populations, exacerbating SMI symptoms. This study examined the documentation and treatment of sleep problems within anonymised clinical records of SMI patients, and their association with attendance rates and number of appointments scheduled. METHODS: Patient records between 01.09.2021 and 31.08.2022 were identified and relevant records (n = 229) extracted from an NHS Trust database. Content analysis was used to assess documentation and treatment of sleep problems and Chi-square tests were used to assess demographic differences. Mann-Whitney U tests were used to compare attendance rates and number of appointments scheduled between patients with/without sleep problems. RESULTS: Most (n = 170; 84 %) patients with sleep problems had no or minimal assessment of the sleep problem within their records. Patients were primarily offered no (n = 115; 57 %) or non-recommended (n = 69; 34 %) sleep treatment. More outpatients were offered no sleep treatment (n = 89; 64 %) than inpatients (n = 26; 41 %) (p = .002) whilst more inpatients were offered non-recommended sleep treatments (n = 33; 52 %) than outpatients (n = 36; 26 %) (p < .001). No significant associations were found between sleep and attendance or appointments scheduled. CONCLUSIONS: There is a lack of routine clinical attention to sleep assessment and treatment in SMI groups. Where sleep is addressed, treatment often conflicts with guidelines. Improved sleep assessment and treatment could significantly enhance current SMI patient care.

Efficacy study comparing a CBT-I developed for shift workers (CBT-I-S) to standard CBT-I (cognitive behavioural therapy for insomnia) on sleep onset latency, total sleep time, subjective sleep quality, and daytime sleepiness: study protocol for a parallel group randomised controlled trial with online therapy groups of seven sessions each.

BACKGROUND: Shift workers are at an increased risk of developing sleep disorders. The standard therapy recommended for sleep disorders is cognitive behavioural therapy for insomnia (CBT-I). Many of its interventions are based on a regular sleep and wake rhythm, which is difficult to apply for shift workers. We have therefore developed a new therapy manual specifically for shift workers (CBT-I-S), which should be more applicable to their needs. In particular, all interventions that require regularity have been removed, and instead, interventions that address factors that proved to be relevant to sleep in our preliminary study have been integrated. We now want to test this manual for its effectiveness. METHODS: A randomised controlled trial with N = 142 will be conducted to compare two conditions: the newly developed therapy manual will be carried out in the experimental group, while cognitive behavioural therapy for insomnia will be employed in the standard group. Both treatments will be conducted online via MS Teams in a group setting with seven sessions each. Data will be collected at three measurement points (pre, post, 6-month follow-up) and analysed using linear mixed models. The study will investigate whether the two treatments have led to significant improvements in total sleep time, sleep onset latency, subjective sleep quality and daytime sleepiness in shift workers. It will also examine whether the new therapy manual is superior to standard therapy in shift workers and whether these effects are stable. DISCUSSION: We assume that interventions designed to address depressive mood, anxiety, worry, rumination, dysfunctional thought patterns and attitudes towards sleep will also improve sleep. If this is indeed the case, these interventions could replace previous ones that require regularity. This could significantly improve the treatment of insomnia in shift workers. TRIAL REGISTRATION: German Clinical Trials Registry DRKS DRKS00032086 . Registered on August 16, 2023.

Sleeping for two: A randomized controlled trial of cognitive behavioural therapy for insomnia (CBTI) delivered in pregnancy and secondary impacts on symptoms of postpartum depression.

BACKGROUND: Insomnia in pregnancy is common and highly comorbid with depression. OBJECTIVE: To investigate if: 1) depressive symptoms decrease after cognitive behavioural therapy for insomnia (CBTI) delivered in pregnancy, and 2) changes in insomnia symptoms represent a mechanism linking CBT-I treatment and reduced symptoms of postpartum depression. METHODS: A two-arm, single-blind, parallel groups randomized controlled trial (RCT) design was used to evaluate the impact of a 5-week CBT-I intervention adapted for pregnant people with insomnia (N = 62). Participants were eligible if they were pregnant, between 12 and 28 weeks gestation, and met diagnostic criteria for insomnia. Participants completed questionnaires assessing symptoms of insomnia and depression pre-intervention (T1), post-intervention (T2), and six months postpartum (T3). A path analysis model was used to test direct and indirect effects simultaneously. RESULTS: There was a significant direct effect of CBT-I on postpartum depressive symptoms at T3. Additionally, significant indirect treatment effects on depressive symptoms at T3 emerged, through depressive symptoms at T2 and through improvements in insomnia that persisted from T2 to T3. LIMITATIONS: Limitations to the current study include limited generalizability, the non-depressed sample, and variability in treatment and assessment delivery (in-person vs. online). CONCLUSIONS: CBT-I treatment in pregnancy may indirectly reduce postpartum depressive symptoms, through sustained improvements in insomnia symptoms.

Cognitive-behavioral treatment for insomnia and mindfulness-based stress reduction in nurses with insomnia: a non-inferiority internet delivered randomized controlled trial.

Background: Insomnia is a highly prevalent sleep disorder frequently comorbid with mental health conditions in nurses. Despite the effectiveness of evidence-based cognitive behavioral therapy for insomnia (CBT-I), there is a critical need for alternative approaches. This study investigated whether internet-delivered mindfulness-based stress reduction (IMBSR) for insomnia could be an alternative to internet-delivered CBT-I (ICBT-I). Objective: The hypothesis was that the IMBSR would be noninferior to the ICBT-I in reducing the severity of insomnia among nurses with insomnia. Additionally, it was expected that ICBT-I would produce a greater reduction in the severity of insomnia and depression than IMBSR. Method: Among 240 screened nurses, 134 with insomnia were randomly allocated (IMBSR, n = 67; ICBT-I, n = 67). The assessment protocol comprised clinical interviews and self-reported outcome measures, including the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), the 15-item Five Facet Mindfulness Questionnaire (FFMQ), and the Client Satisfaction Questionnaire (CSQ-I). Results: The retention rate was 55% with 77.6% (n = 104) of participants completing the study. At post-intervention, the noninferiority analysis of the ISI score showed that the upper limit of the 95% confidence interval was 4.88 (P = 0.46), surpassing the pre-specified noninferiority margin of 4 points. Analysis of covariance revealed that the ICBT-I group had significantly lower ISI (Cohen's d = 1.37) and PHQ-9 (Cohen's d = 0.71) scores than did the IMBSR group. In contrast, the IMBSR group showed a statistically significant increase in the FFMQ-15 score (Cohen's d = 0.67). Within-group differences showed that both the IMBSR and ICBT-I were effective at reducing insomnia severity and depression severity and improving mindfulness. Conclusion: Overall, nurses demonstrated high levels of satisfaction and adherence to both interventions. The IMBSR significantly reduced insomnia severity and depression, but the findings of this study do not provide strong evidence that the IMBSR is at least as effective as the ICBT-I in reducing insomnia symptoms among nurses with insomnia. The ICBT-I was found to be significantly superior to the IMBSR in reducing insomnia severity, making it a recommended treatment option for nurses with insomnia.

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Comparing patients treated with CBT for insomnia with healthy sleepers and sleepers with past insomnia on dimensions of sleep health.

OBJECTIVES: To compare patients treated with cognitive behavioral therapy for insomnia (CBT-I) with healthy sleepers and individuals with past but not current insomnia on multidimensional sleep health. METHODS: The study evaluates CBT-I on six dimensions of sleep health (regularity, satisfaction, alertness, timing, efficiency, duration) in a sample of individuals with insomnia compared to two other unique sleep samples. Participants were in one of three groups: insomnia (CUR, n = 299), healthy sleeper (HS, n = 122), or past insomnia (PAST, n = 35). Daily diaries and validated measures were employed to capture six dimensions of sleep health. The CUR group received four 60-minute sessions of CBT-I every 2weeks, and sleep health indices were measured at baseline and post-treatment. The HS and PAST groups were measured only at baseline. RESULTS: Results of the pairwise t tests indicated improvements in sleep satisfaction, alertness (fatigue but not sleepiness), timing, efficiency, and duration (Cohen's d=0.22 to 1.55). ANCOVA models revealed significant differences in sleep health scores between treated insomnia patients and the other two sleep groups. Treated patients demonstrated less bedtime and risetime variability, in addition to lower napping duration. Overall, the study observed significant changes in various domains of sleep health after four sessions of cognitive behavioral therapy for insomnia; however, differences remain when compared to the other groups in the study. CONCLUSION: There may be ongoing sleep vulnerability in patients treated with cognitive behavioral therapy for insomnia though future inclusion of a control group would increase internal validity. Borrowing from transdiagnostic sleep modules may be helpful to support remaining deficits after cognitive behavioral therapy for insomnia.

Clinico-demographic factors associated with the treatment response to cognitive behavioral therapy for insomnia.

BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) is among the recommended non-pharmacological treatments for patients with insomnia. While there are multiple reports on the effects of CBT-I treatment, few studies evaluating the factors associated with the treatment response to CBT-I have been reported. The present study aimed to confirm the effects of CBT-I in patients with insomnia and to examine the clinico-demographic factors that can predict the outcomes of CBT-I in these patients. METHODS: Overall, 62 patients were included in the present study. To confirm the effectiveness of CBT-I, we compared the pre- and post-CBT-I therapy values of several sleep parameters. Furthermore, to identify the clinico-demographic factors that could be predictive of the treatment response to CBT-I, we performed generalized linear model (GLM) analysis. RESULTS: The values of several sleep parameters were significantly lower after treatment than at baseline. The results of the GLM analysis revealed that sex and occupation were significantly associated with the treatment response to CBT-I. CONCLUSIONS: The present results suggest that several clinico-demographic factors should be considered in the treatment of patients with insomnia.

Insomnia.

Sleep significantly impacts health. Insomnia, characterized by difficulty with sleep onset, maintenance, and subsequent daytime symptoms, is increasingly prevalent and increases the risk of other medical comorbidities. The pathophysiology involves hyperarousal during non-REM sleep and altered sleep homeostasis. The 3P model explains the development and persistence of insomnia. Assessment is primarily clinical and based on appropriate history while distinguishing from other sleep disorders. "Somnomics" suggests a personalized approach to management. Cognitive behavioral therapy for insomnia is the first-line treatment in addition to other nonpharmacological strategies. Medications are a secondary option with weak supporting evidence.

Comorbid Insomnia and Sleep Apnea: Challenges and Treatments.

Insomnia and obstructive sleep apnea (OSA) are 2 of the most prevalent sleep disorders and frequently co-occur. Cognitive behavioral therapy for insomnia is the first line treatment for insomnia and has been shown to improve compliance with positive airway pressure therapy. Other alternatives to OSA treatment may have higher acceptance in those with comorbid insomnia and sleep apnea (COMISA). Surgery, particularly hypoglossal nerve stimulation, appears to be well tolerated and may improve insomnia in those with COMISA. Otolaryngologists must be cognizant of the common presentation of COMISA in patients seeking surgical treatment and utilize a multidisciplinary approach.

Toward personalized care for insomnia in the US Army: a machine learning model to predict response to cognitive behavioral therapy for insomnia.

STUDY OBJECTIVES: The standard of care for military personnel with insomnia is cognitive behavioral therapy for insomnia (CBT-I). However, only a minority seeking insomnia treatment receive CBT-I, and little reliable guidance exists to identify those most likely to respond. As a step toward personalized care, we present results of a machine learning (ML) model to predict CBT-I response. METHODS: Administrative data were examined for n = 1,449 nondeployed US Army soldiers treated for insomnia with CBT-I who had moderate-severe baseline Insomnia Severity Index (ISI) scores and completed 1 or more follow-up ISIs 6-12 weeks after baseline. An ensemble ML model was developed in a 70% training sample to predict clinically significant ISI improvement (reduction of at least 2 standard deviations on the baseline ISI distribution). Predictors included a wide range of military administrative and baseline clinical variables. Model accuracy was evaluated in the remaining 30% test sample. RESULTS: 19.8% of patients had clinically significant ISI improvement. Model area under the receiver operating characteristic curve (standard error) was 0.60 (0.03). The 20% of test-sample patients with the highest probabilities of improvement were twice as likely to have clinically significant improvement compared with the remaining 80% (36.5% vs 15.7%; χ21 = 9.2, P = .002). Nearly 85% of prediction accuracy was due to 10 variables, the most important of which were baseline insomnia severity and baseline suicidal ideation. CONCLUSIONS: Pending replication, the model could be used as part of a patient-centered decision-making process for insomnia treatment. Parallel models will be needed for alternative treatments before such a system is of optimal value. CITATION: Gabbay FH, Wynn GH, Georg MW, et al. Toward personalized care for insomnia in the US Army: a machine learning model to predict response to cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2024;20(6):921-931.

Treatment for behavioral insomnia in young children with neurotypical development under 6 years of age: A systematic review.

This literature review examines all treatments for behavioral insomnia in children under 6 years of age to determine which treatments have empirically demonstrated efficacy. Following PRISMA guidelines, three databases were investigated (Pubmed, Cochrane and Psychinfo) to select randomized controlled trials (RCTs) which assess treatments for behavioral insomnia in children under 6 years of age, all with neurotypical development. A total of 908 articles met the search criteria. 21 articles were selected and analyzed in their entirety for a total of 2363 children (ranging from 2 months to 6 years of age). Based on these studies, treatment of behavioral insomnia in young children under 6 years of age is primarily based on behavioral therapy. There is no evidence that pharmacological treatments are effective in the long term for neurotypical children. This review highlights the lack of RCTs in this field: new RCTs should be carried out among young children to refine and optimize the therapeutic approach and to address the risk of therapeutic abuse through the use of non-scientifically validated methods.

Preliminary study: cognitive behavioural therapy for insomnia in adolescents with anorexia nervosa.

PURPOSE: Insomnia and anorexia nervosa (AN) are frequently comorbid, negatively affecting the evolution and the prognosis of AN. Within this framework, the management of sleep disorders appears as critical. The aim of this retrospective study is to assess, for the first time, the efficacy of cognitive and behavioural therapy for insomnia (CBT-I) on sleep disturbances in adolescents with AN. To do so, we investigated the impact of CBT-I on sleep disturbances and sleep-related outcomes, in BMI, AN symptoms, anxiety and depressive symptoms, emotionality and quality of life. These features were compared between two groups of patients with AN, one following CBT-I, and the other receiving the regular treatment at the psychiatric unit. METHODS: Data collection occurred between January and May 2022. The study included 42 adolescents in-treatment at the Eating Disorders care specialised unit at Salvator Hospital in Marseille. They were randomly assigned to the CBT-I group (N = 31) or the control group (N = 11). Several clinical elements were assessed using sleep diaries and self-report questionnaires. RESULTS: Participants undergoing CBT-I showed a significant improvement in sleep latency, total wake time and sleep efficacy, as well as in physical well-being. No significant effects were found regarding AN symptoms. CONCLUSION: These preliminary findings provide support for CBT-I effectiveness in adolescents with AN, as shown by significant improvements in several sleep parameters, as well as in physical well-being. These promising results, underline the relevance of this topic and its potential benefits for a more appropriate treatment for adolescents with AN. LEVEL OF EVIDENCE: Level V, retrospective study.

Behavioral Interventions to Improve Sleep Outcomes in Individuals With Multiple Sclerosis: A Systematic Review.

BACKGROUND: Sleep disturbances are common in individuals with multiple sclerosis. The objective of this systematic review was to determine effective behavioral interventions to improve their sleep. METHODS: Literature searches were performed in December 2021 in Ovid MEDLINE, Elsevier Embase, and Web of Science, along with hand searching for grey literature and cited references. Four reviewers independently reviewed titles and abstracts (2 reviewers for each article; n = 830) and the full-text articles (n = 81). Consensus for inclusion was achieved by a fifth reviewer. Thirty-seven articles were eligible for inclusion. Four reviewers extracted relevant data from each study (2 reviewers for each article) using a standard data extraction table. Consensus was achieved for completeness and accuracy of the data extraction table by a fifth reviewer. The same 4 reviewers conducted a quality appraisal of each article to assess the risk of bias and quality of the articles, and consensus was achieved by a fifth reviewer as needed. Descriptive data were used for types of interventions, sleep outcomes, results, and key components across interventions. RESULTS: Overall, the cognitive behavioral therapy for insomnia, cognitive behavioral therapy/psychotherapy, and education/self-management support interventions reported positive improvements in sleep outcomes. Quality appraisal scores ranged from low to high, indicating potential for bias. CONCLUSIONS: Variability in the intervention type, intervention dose, outcomes used, training/expertise of interventionist, specific sample, and study quality made it difficult to compare and synthesize results. Further research is necessary to demonstrate the efficacy of most of the interventions.