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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. [ABSTRACT FROM AUTHOR]

• Sleep and circadian problems are often comorbid with mental disorders. • Sleep and circadian problems are mechanistic contributors to mental disorders. • TranS-C treats sleep and circadian problems across mental disorders via one protocol. • TranS-C is grounded in basic sleep and circadian science and existing EBPTs. • TranS-C includes cognitive-behavioral therapy for insomnia (CBT-I) The transdiagnostic intervention for sleep and circadian dysfunction (TranS-C) was developed to provide one protocol that treats a range of sleep and circadian problems across a range of mental disorders. The focus of TranS-C includes, and goes beyond, categorically defined sleep and circadian disorders to facilitate healthy sleep along empirically derived "sleep health" dimensions. In this State of the Science review, we highlight key advantages of a transdiagnostic approach to sleep and circadian problems, including (a) the potential to better understand and treat comorbidity between various sleep and circadian problems and mental disorders, as well as the potential to better understand and treat the heterogeneous sleep and circadian problems that are present within a specific mental disorder; (b) the opportunity to explore the hypothesis that sleep and circadian problems are an important transdiagnostic mechanism in the multifactorial maintenance of mental disorders; (c) the potential to transfer breakthroughs made across siloed areas of research and practice; (d) its suitability for dissemination into a broad range of settings, particularly lower resource settings; and (e) the opportunity to improve a range of important outcomes. We also explain the theoretical underpinnings of TranS-C, including the two-process model of sleep regulation and the Sleep Health Framework. TranS-C includes cognitive-behavioral therapy for insomnia (CBT-I) and we offer recommendations for when to use CBT-I versus TranS-C. The process for developing TranS-C is discussed along with outcome data, applications to underserved communities, and future directions for research. [ABSTRACT FROM AUTHOR]

AbstractObjective: This study examined the feasibility, acceptability, and efficacy of a self-guided, mobile application for Cognitive Behavioral Therapy for Insomnia (CBT-I Coach) in a sample of college students. Participants: Data was collected from 55 students, who mostly identified as women (82%) and white (84%) and reported at least moderate insomnia symptoms based on the Insomnia Severity Index. Methods: Participants were randomized to either an intervention condition (i.e., 4 wk of CBT-I Coach) or a wait-list condition and completed self-report measures biweekly across the 8-week study period. Results: Nearly 70% of participants found the app moderately to extremely effective. The intervention group experienced a larger reduction in insomnia symptoms from baseline to post-treatment compared to the control group (g = 0.88). Conclusions: These findings provide preliminary evidence that utilizing a self-guided mobile intervention for insomnia among college students is feasible and components of the app were perceived to be moderately to highly effective. [ABSTRACT FROM AUTHOR]

Insomnia in pregnancy is common and highly comorbid with depression. To investigate if: 1) depressive symptoms decrease after cognitive behavioural therapy for insomnia (CBT I) delivered in pregnancy, and 2) changes in insomnia symptoms represent a mechanism linking CBT-I treatment and reduced symptoms of postpartum depression. 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. 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 to the current study include limited generalizability, the non-depressed sample, and variability in treatment and assessment delivery (in-person vs. online). CBT-I treatment in pregnancy may indirectly reduce postpartum depressive symptoms, through sustained improvements in insomnia symptoms. • Research on the effectiveness of CBT-I in pregnancy to alleviate depressive symptoms is mixed. • CBT-I delivered in pregnancy had lasting anti-depressive effects in the postpartum period. • CBT-I reduces postpartum depressive symptoms through sustained improvements in postpartum insomnia symptoms. • CBT-I in pregnancy may indirectly reduce postpartum depressive symptoms. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 cognitivebehavioral 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. 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 cognitivebehavioral 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Cognitive behavioral therapy for insomnia (CBT-I) is the recommended treatment for insomnia, yet multiple barriers limit utilization. Digital CBT-I may present a solution, though related reviews have focused on Internet-based delivery rather than app use. The high utilization of health apps and prevalence of sleep apps indicate the need to equip clinicians with app-specific research. Toward this end, we reviewed efficacy and quality data on self-management CBT-I smartphone apps, revealing efficacy research on eleven apps, five of which were publicly available. While preliminary, these efficacy studies showed consistent positive findings. When examining quantitative quality indicators for the five publicly available apps, two had consistent data. Overall, two apps, CBTi Coach and Insomnia Coach, had positive, empirical findings across all efficacy and quality assessment approaches. We provide recommendations to guide clinician decision making regarding CBT-I self-management apps based on the literature and publicly available methods of app evaluations. [ABSTRACT FROM AUTHOR]

Jia Wei,1,&ast; Mingfen Song,1,&ast; Hong Jing Mao,1 Ruobing Qi,1 Lili Yang,1 You Xu,1 Pan Yan,1 Linlin Hu2 1Affiliated Mental Health Center & Hangzhou Seventh People’s Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310013, People’s Republic of China; 2Sleep Medicine Center, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310013, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Hong Jing Mao, Email maohongjing@hz7hospital.comBackground: 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.Keywords: insomnia, CBT-I, PSQI, influencing factors

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

Summary: Due to insufficient treatment options for insomnia, effective solutions are urgently needed. We evaluated the effects of a CBT‐I‐based app combining sleep training with subjective and objective sleep monitoring on (i) sleep and (ii) subjective‐objective sleep discrepancies (SOSD). Fifty‐seven volunteers (20–76 years; MAge = 45.67 ± 16.38; 39 female) suffering from sleep problems were randomly assigned to an experimental group (EG, n = 28) or a waitlist control group (CG, n = 29). During the 6‐week app phase, the EG used the CBT‐I‐based programme and a heart rate sensor for daily sleep monitoring and ‐feedback, while the CG used sleep monitoring only. Sleep was measured (i) subjectively via questionnaires (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), (ii) objectively via ambulatory polysomnography (PSG), and (iii) continuously via heart‐rate sensor and sleep diaries. Data revealed interactions for ISI (p = 0.003, ƞ2part = 0.11) and PSQI (p = 0.050, ƞ2part = 0.05), indicating training‐specific improvements in EG, yet not in CG. While PSG‐derived outcomes appear to be less training‐specific, a tendential reduction in wake after sleep onset (WASO) was found in EG (p = 0.061, d = 0.55). Regarding changes in SOSD, the results indicate improvements during the app phase (EG) for sleep efficiency, sleep onset latency, and WASO (p ≤ 0.022, d ≥ 0.46); for total sleep time both groups showed a SOSD reduction. The findings indicate beneficial effects of a novel smartphone app on sleep and SOSD. More scientific evaluation of such digital programmes is needed to ultimately help in reducing the gap in non‐pharmacological insomnia treatment. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

IntroductionChronic 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. MethodsThis 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.ResultsAfter 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

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.

Abstract 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.

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. [ABSTRACT FROM AUTHOR]

Background: Insomnia is highly prevalent and cognitive behavioural therapy is the first-line treatment for it. This study aimed to assess the efficacy of remote cognitive behavioural therapy for insomnia, specifically, treatment fully delivered through the internet, mobile phones and telephones for sleep and other health outcomes in adults diagnosed with insomnia or reporting insomnia symptoms. This study also aimed to evaluate the effect of various intervention components as subgroup variables to explain the efficacy of remote cognitive behavioural therapy on health outcomes. Methods: Randomised controlled trial studies were obtained from five electronic databases. The PEDro scale was used to assess the quality of the studies. A random effect model was used to assess the mean difference, standardised mean difference and standard deviation of the outcome variables. Heterogeneity among the study articles was assessed using I2 and Q tests. Egger regression analysis was used to assess publication bias. Results: Remote cognitive behavioural therapy for insomnia had significant and positive effects on improving sleep outcomes, depression, anxiety, fatigue and mental health compared with the control conditions. Its effect on physical health was not significant. The effect of the therapy was enhanced when the total length of intervention was shorter than 6 weeks, delivered via the internet and did not include therapist support. Conclusion: Remote cognitive behavioural therapy for insomnia is effective in improving sleep quality, depression, anxiety, fatigue and mental health in insomnia patients. [ABSTRACT FROM AUTHOR]

Summary: There is a strong relationship between the symptoms of insomnia and depression, however, little is understood about the factors that mediate this relationship. An understanding of these underlying mechanisms may inform the advancement of existing treatments to optimise reductions in insomnia and depression when they co‐occur. This study examined rumination and unhelpful beliefs about sleep as mediators between symptoms of insomnia and depression. It also evaluated the effect of cognitive behavioural therapy for insomnia (CBT‐I) on rumination and unhelpful beliefs about sleep, and whether these factors mediated the effect of CBT‐I on depressive symptoms. A series of mediation analyses and linear mixed modelling were conducted on data from 264 adolescents (12–16 years) who participated in a two‐arm (intervention vs. control) randomised controlled trial of Sleep Ninja®, a CBT‐I smartphone app for adolescents. Rumination, but not unhelpful beliefs about sleep, was a significant mediator between symptoms of insomnia and depression at baseline. CBT‐I led to reductions in unhelpful beliefs about sleep, but not in rumination. At the between‐group level, neither rumination, nor unhelpful beliefs about sleep emerged as mechanisms underlying improvement in depression symptoms, however, rumination mediated within‐subject improvements following CBT‐I. The findings suggest rumination links symptoms of insomnia and depression and provide preliminary evidence that reductions in depression following CBT‐I occurs via improvements in rumination. Targeting rumination may improve current therapeutic approaches. [ABSTRACT FROM AUTHOR]

The last ten years have seen the development and publication of numerous national and international guidelines devoted to the diagnosis and treatment of insomnia. These include guidelines by the American College of Physicians (ACP), the American Academy of Sleep Medicine (AASM), the British Sleep Society (BSS), the German Sleep Society (GSS), and the European Sleep Research Society (ESRS). Though coming from very diverse authors and backgrounds, these guidelines by and large agree concerning the therapeutic recommendations: cognitive behavioral treatment of insomnia (CBT-I), a multicomponent psychotherapeutic intervention, is unequivocally recommended as a first-line treatment. In this report, we will focus on the most recent guideline update from the ESRS, which was published in November 2023. After suggesting a careful diagnostic procedure, CBT-I, both applied face to face (F2F) or digitally (dCBT-I), is again recommended as a first-line treatment based on the available evidence. Hypnotic medications like benzodiazepines (BZ), benzodiazepine receptor agonists (BZRA), sedating antidepressants, and others are approved for short-term-treatment of up to four weeks. Orexin receptor antagonists (i.e., daridorexant) and prolonged release melatonin are considered as options for longer-term treatment when carefully considering the advantages and disadvantages. Both light therapy and exercise regimens were viewed as promising; however, they still lack convincing evidence for the time being. Given the fact that not every patient responds satisfactorily or even remits following CBT-I or other treatment options, the research agenda calls for the development and evaluation of new therapeutic avenues and combination therapies. [ABSTRACT FROM AUTHOR]

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.

Abstract 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.

Purpose: For cancer survivors, insomnia is highly prevalent and debilitating. Although cognitive behavioral therapy for insomnia (CBT-I) is recognized as a gold standard treatment, it is unclear whether benefits of treatment generalize to racial and ethnic minorities in the USA. This systematic review characterizes the representation of racial and ethnic diversity among cancer survivors in CBT-I clinical trials and provides recommendations for research in sleep/cancer survivorship. Methods: Literature searches were conducted in five electronic databases (PubMed, Cochrane Library via Ovid, PsycINFO via Ovid, Embase, Web of Science Core Collection) using concepts of CBT, insomnia, and cancer survivors. Information about CBT-I intervention details, sample racial demographics, and whether authors explicitly analyzed race and ethnicity were recorded. Results: A total of 1673 citations were retrieved, and 967 citations were uploaded to Covidence. Of these, 135 articles went through full-text review and 13 studies were included. Race and ethnicity were reported in 11/13 trials (84.6%). Of those reporting race and ethnicity, 8/11 (72.7%) trials were comprised of samples that were ≥ 85% non-Hispanic White. Among the trials that explicitly analyzed race and ethnicity, CBT-I was more effective among cancer survivors who were White and highly educated, and non-White cancer survivors were less likely to have private insurance and ability to participate in clinical trials. Conclusion: Non-Hispanic White cancer survivors are overrepresented in CBT-I trials, the best available treatment for insomnia. Underrepresentation of racial and ethnic minorities likely contributes to barriers in access and uptake. Recommendations include implementing sustained efforts to expand diversity in CBT-I clinical trials for cancer survivors. [ABSTRACT FROM AUTHOR]

There is an urgent need for easily accessible treatment options for sleep problems to reduce the current treatment gap in receiving cognitive behavioral therapy for insomnia (CBT-I). Using a randomized controlled trial, we evaluated the efficacy of a CBT-I-based online program on sleep. Fifty-three volunteers (21–71 years; MAge = 44.6 ± 12.5; 27 female) suffering from impaired sleep were randomly allocated either to the experimental group (EG, n = 27) or to an active control group (CG, n = 26). The EG participated in a 6-week CBT-I-based online program, while the CG received psychoeducation and sleep hygiene instructions. Sleep was assessed both objectively via ambulatory polysomnography (PSG) as well as subjectively via questionnaires at three time points (baseline, pre- and post-intervention). A one-month follow-up assessment was performed using questionnaires. The EG showed small but reliable improvements from pre- to post-intervention in PSG-derived wake after sleep onset (from 58.6 min to 42.5 min; p < 0.05) and sleep efficiency (from 86.0% to 89.2%; p < 0.05). Furthermore, subjective sleep quality (assessed via Pittsburgh Sleep Quality Index) improved significantly during intervention (p = 0.011) and follow-up (p = 0.015) in the EG alone. The Insomnia Severity Index decreased from pre- to post-intervention in both groups (EG: p = 0.003, CG: p = 0.008), while it further improved during follow-up (p = 0.035) in the EG alone. We show that a CBT-I-based online program can improve sleep not only subjectively but also objectively and can be a viable alternative when face-to-face interventions are not available. [ABSTRACT FROM AUTHOR]

Summary: Insomnia is highly prevalent among patients with psychiatric disorders. According to current guidelines, cognitive behavioural therapy for insomnia (CBT‐I) represents the first‐line treatment for chronic insomnia, also for patients with psychiatric comorbidity. While recent studies have demonstrated that CBT‐I not only improves insomnia but also other health outcomes in patients with psychiatric disorders and comorbid insomnia in outpatient settings, the level of implementation and treatment potential of CBT‐I in inpatient psychiatry is less clear. The objective of this systematic review is to present and discuss studies that have adapted CBT‐I for inpatient psychiatric care. PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO, were searched until June 2023. A total of 10 studies were identified, with the majority being non‐randomised trials without comparison groups and small sample sizes. With preliminary character, studies report feasibility and potential efficacy in inpatient settings. Together, this review identifies a paucity of studies on CBT‐I or derivates in inpatient psychiatry. Despite challenging in this setting, studies adapting CBT‐I to the needs of severely ill patients and hospital settings might have the potential to improve mental health care. [ABSTRACT FROM AUTHOR]

Summary: Cognition is central to the experience of insomnia. Although unhelpful thoughts about and around insomnia are a primary treatment target of cognitive behaviour therapy for insomnia, cognitive constructs are termed and conceptualised differently in different theories of insomnia proposed over the past decades. In search of consensus in thinking, the current systematic review identified cognitive factors and processes featured in theoretical models of insomnia and mapped any commonality between models. We systematically searched PsycINFO and PubMed for published theoretical articles on the development, maintenance and remission of insomnia, from inception of databases to February, 2023. A total of 2458 records were identified for title and abstract screening. Of these, 34 were selected for full‐text assessment and 12 included for analysis and data synthesis following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. We identified nine distinguishable models of insomnia published between 1982 and 2023 and extracted 20 cognitive factors and processes featured in these models; 39 if sub‐factors were counted. After assigning similarity ratings, we observed a high degree of overlap between constructs despite apparent differences in terminologies and measurement methods. As a result, we highlight shifts in thinking around cognitions associated with insomnia and discuss future directions. [ABSTRACT FROM AUTHOR]

There is an urgent need for easily accessible treatment options for sleep problems to reduce the current treatment gap in receiving cognitive behavioral therapy for insomnia (CBT-I). Using a randomized controlled trial, we evaluated the efficacy of a CBT-I-based online program on sleep. Fifty-three volunteers (21–71 years; MAge = 44.6 ± 12.5; 27 female) suffering from impaired sleep were randomly allocated either to the experimental group (EG, n = 27) or to an active control group (CG, n = 26). The EG participated in a 6-week CBT-I-based online program, while the CG received psychoeducation and sleep hygiene instructions. Sleep was assessed both objectively via ambulatory polysomnography (PSG) as well as subjectively via questionnaires at three time points (baseline, pre- and post-intervention). A one-month follow-up assessment was performed using questionnaires. The EG showed small but reliable improvements from pre- to post-intervention in PSG-derived wake after sleep onset (from 58.6 min to 42.5 min; p < 0.05) and sleep efficiency (from 86.0% to 89.2%; p < 0.05). Furthermore, subjective sleep quality (assessed via Pittsburgh Sleep Quality Index) improved significantly during intervention (p = 0.011) and follow-up (p = 0.015) in the EG alone. The Insomnia Severity Index decreased from pre- to post-intervention in both groups (EG: p = 0.003, CG: p = 0.008), while it further improved during follow-up (p = 0.035) in the EG alone. We show that a CBT-I-based online program can improve sleep not only subjectively but also objectively and can be a viable alternative when face-to-face interventions are not available.

Various digital sleep interventions have been implemented to address sleep and psychological complications during the coronavirus disease 2019 (COVID-19) pandemic. However, the characteristics and effectiveness of digital sleep interventions on sleep and psychological outcomes for people with sleep problems during the COVID-19 pandemic are unknown. The protocol of this systematic review and meta-analysis was registered on PROSPERO (ID: CRD42022325662), seven databases were searched from December 2019 to June 2023. Reference lists from digital sleep reviews were also identified and selected. Two reviewers independently screened eligible articles and extracted data. Quality appraisal was undertaken by two independent reviewers using the Cochrane Risk-of-Bias Tools. Data synthesis was conducted using fixed- or random-effects model based on the results of the heterogeneity test. A total of 20 studies were identified, including nine randomised controlled trials (RCTs) and 11 non-RCTs, involving 3860 participants. Meta-analyses showed that digital sleep interventions significantly improve sleep quality, insomnia, and depression during the COVID-19 pandemic. Subgroup analysis showed that interventions of more than four weeks, healthcare workers as participants, and relaxation therapies may have the advantage of improving sleep quality. Most non-RCTs supported the efficacy of digital sleep interventions on sleep and psychological health. Digital sleep interventions during the COVID-19 pandemic had significant effectiveness in improving sleep and psychological outcomes for people with sleep problems. More structured and personalised digital sleep interventions should be designed, and other diverse digital technologies could be used to improve sleep and psychological disorders. • The COVID-19 pandemic has caused a higher risk of sleep disorders and increased psychological problems. • Digital sleep interventions significantly improve sleep quality, insomnia, and depression during the COVID-19 pandemic. • Longer intervention duration, healthcare providers as participants, and relaxation therapy may have more benefits on sleep. • Future research could further explore the role of digital technologies in sleep assessment, management, and resources sharing. [ABSTRACT FROM AUTHOR]

Insomnia is characterized by frequent and persistent difficulties initiating and maintaining sleep, along with impaired daytime functioning. Blended treatments are increasingly popular for treating psychological disorders such as depression. Blended treatments combine elements of face-to-face therapy and online interventions. A single-arm pre-post study investigated the feasibility of a blended treatment combining face-to-face cognitive behavioral therapy for insomnia and internet-based cognitive behavioral therapy for insomnia (SLEEPexpert+). The findings show that the therapists have a positive attitude toward blended CBT-I (b-CBT-I) and that they feel supported by the online components of the treatment. Possible barriers to implementing blended treatments are integrating the online materials into the face-to-face sessions and adapting one's therapeutic style to the blended treatment approach. No definitive statements about the effectiveness of the b-CBT-I treatment can be made. However, of the six presented cases, five patients showed notably higher sleep efficiency and fewer insomnia symptoms at the end of the therapy. Program usage data indicate that participants mainly used the online components at the beginning of their treatment. Future studies should investigate the effectiveness of b-CBT-I with a sufficiently powered randomized controlled trial comparing b-CBT-I with an adequate control group in routine care. [ABSTRACT FROM AUTHOR]

Unlocking the power of rest The Gift of the Night: A Six-Step Program for Better Sleep by Philip Carr-Gomm presents a holistic approach to achieving restful sleep by seamlessly blending psychology, spirituality, and practical insights. Carr-Gomm's integration of Transpersonal Psychology and Cognitive behavioural Therapy for Insomnia (CBT-I) offers readers a transformative framework for reframing their relationship with sleep. Structured into two parts, the book provides a comprehensive toolkit for enhancing sleep quality, including a six-step program and a troubleshooting guide. Carr-Gomm's transpersonal perspective illuminates the spiritual dimensions of sleep, inviting readers to embrace the night as a sacred space for renewal. While acknowledging its limitations for certain individuals, the book serves as a valuableresource for those looking to unlock the trans for mative power of rest ful sleep. [ABSTRACT FROM AUTHOR]

Summary: Sleep restriction therapy is a central component of cognitive behavioural therapy for insomnia, but can lead to excessive sleepiness, which may impede treatment adherence. Sleep compression therapy has been suggested as a possibly gentler alternative. The aim of this study was to compare the effects of sleep restriction therapy and sleep compression therapy on objective measures of sleep, with a focus on magnitude and timing of effects. From a larger study of participants with insomnia, a sub‐sample of 36 underwent polysomnographic recordings, before being randomised to either sleep restriction (n = 19) or sleep compression (n = 17) and receiving online treatment for 10 weeks. Assessments with polysomnography were also carried out after 2, 5, and 10 weeks of treatment. Data were analysed with multilevel linear mixed effect modelling. As per treatment instructions, participants in sleep restriction initially spent shorter time in bed compared with sleep compression. Participants in sleep restriction also showed an initial decrease of total sleep time, which was not seen in the sleep compression group. Both treatments led to improvements in sleep continuity variables, with a tendency for the improvements to come earlier during treatment in sleep restriction. No substantial differences were found between the two treatments 10 weeks after the treatment start. The results indicate that homeostatic sleep pressure may not be as important as a mechanism in sleep compression therapy as in sleep restriction therapy, and an investigation of other mechanisms is needed. In conclusion, the treatments led to similar changes in objective sleep at a somewhat different pace, and possibly through different mechanisms. [ABSTRACT FROM AUTHOR]

Background: While the negative consequences of insomnia are well-documented, a strengths-based understanding of how sleep can increase health promotion is still emerging and much-needed. Correlational evidence has connected sleep and insomnia to resilience; however, this relationship has not yet been experimentally tested. This study examined resilience as a mediator of treatment outcomes in a randomized clinical trial with insomnia patients. Methods: Participants were randomized to either digital cognitive behavioral therapy for insomnia (dCBT-I; n = 358) or sleep education control (n = 300), and assessed at pre-treatment, post-treatment, and 1-year follow-up. A structural equation modeling framework was utilized to test resilience as a mediator of insomnia and depression. Risk for insomnia and depression was also tested in the model, operationalized as a latent factor with sleep reactivity, stress, and rumination as indicators (aligned with the 3-P model). Sensitivity analyses tested the impact of change in resilience on the insomnia relapse and incident depression at 1-year follow-up. Results: dCBT-I resulted in greater improvements in resilience compared to the sleep education control. Furthermore, improved resilience following dCBT-I lowered latent risk, which was further associated with reduced insomnia and depression at 1-year follow-up. Sensitivity analyses indicated that each point improvement in resilience following treatment reduced the odds of insomnia relapse and incident depression 1 year later by 76% and 65%, respectively. Conclusions: Improved resilience is likely a contributing mechanism to treatment gains following insomnia therapy, which may then reduce longer-term risk for insomnia relapse and depression. [ABSTRACT FROM AUTHOR]

Abstract Background Insomnia and poor sleep quality are highly prevalent conditions related to coronavirus disease 2019 (COVID-19) complications among clinical nurses. Although cognitive behavioral therapy for insomnia (CBT-I) is a first-line treatment, CBT-I suffers from several major drawbacks. This study investigates whether the application of the internet-delivered mindfulness-based stress reduction (iMBSR) intervention will produce effects that are non-inferior to the internet-delivered CBT-I (iCBT-I) intervention in reducing the severity of insomnia in clinical nurses with insomnia at the end of the study. Methods This study protocol presents an internet-delivered, parallel-groups, assessor-blinded, two-arm, non-inferiority randomized controlled trial. The primary outcome is sleep quality, assessed by the Insomnia Severity Index. Secondary outcomes include depression, dysfunctional beliefs, five facets of mindfulness, and client satisfaction. Conclusion It is expected that this study may address several gaps in the literature. The non-inferiority study design is a novel approach to evaluating whether a standardized, complementary treatment (i.e., MBSR) is as practical as a gold standard treatment rather than its potential benefits. This approach may lead to expanded evidence-based practice and improve patient access to effective treatments. Trial registration Trial registration number: ISRCTN36198096 . Registered on 24th May 2022.

Abstract Background Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD. Methods/design We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes. Discussion This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression. Trial registration ClinicalTrials.gov NCT03322774. Registered on October 26, 2017

Background: School-based sleep education programmes can promote the importance of sleep health and may improve adolescent sleep. To date, only limited research has examined the feasibility of integrating sleep programmes into the school curriculum. Objectives: This study evaluated the feasibility, acceptability and preliminary efficacy of the Strathclyde intervention to encourage good sleep health in teenagers (SIESTA). Methods: A total 171 students (12–15 years, 53% women) from secondary schools in Scotland participated in the study. Recruitment and retention, data collection and design procedures were assessed to establish feasibility. Qualitative feedback on acceptability was collected via focus group discussions. Outcome measures assessing insomnia symptoms, sleep hygiene, depression, anxiety and stress were completed at baseline and post-intervention to explore the preliminary effects of SIESTA. Results: All schools that were approached consented to participate, and most students completed assessments at both time points (171) with a dropout rate of 5%. Assessment measures provided sufficient data to compare baseline and post-intervention values. Training and delivery manuals ensured successful delivery of the programme. Qualitative feedback indicated SIESTA was acceptable, and students spoke favourably about the content, delivery and techniques. Students reported that SIESTA was age-appropriate, relevant and the techniques were beneficial. There were significant improvements in insomnia and stress, but no improvements were noted for sleep hygiene, depression or anxiety. Conclusion: The findings suggest that SIESTA is feasible and acceptable for delivery via the school curriculum. The results indicate that a controlled trial is required to further investigate the efficacy of SIESTA implemented in an educational context. [ABSTRACT FROM AUTHOR]

The last ten years have seen the development and publication of numerous national and international guidelines devoted to the diagnosis and treatment of insomnia. These include guidelines by the American College of Physicians (ACP), the American Academy of Sleep Medicine (AASM), the British Sleep Society (BSS), the German Sleep Society (GSS), and the European Sleep Research Society (ESRS). Though coming from very diverse authors and backgrounds, these guidelines by and large agree concerning the therapeutic recommendations: cognitive behavioral treatment of insomnia (CBT-I), a multicomponent psychotherapeutic intervention, is unequivocally recommended as a first-line treatment. In this report, we will focus on the most recent guideline update from the ESRS, which was published in November 2023. After suggesting a careful diagnostic procedure, CBT-I, both applied face to face (F2F) or digitally (dCBT-I), is again recommended as a first-line treatment based on the available evidence. Hypnotic medications like benzodiazepines (BZ), benzodiazepine receptor agonists (BZRA), sedating antidepressants, and others are approved for short-term-treatment of up to four weeks. Orexin receptor antagonists (i.e., daridorexant) and prolonged release melatonin are considered as options for longer-term treatment when carefully considering the advantages and disadvantages. Both light therapy and exercise regimens were viewed as promising; however, they still lack convincing evidence for the time being. Given the fact that not every patient responds satisfactorily or even remits following CBT-I or other treatment options, the research agenda calls for the development and evaluation of new therapeutic avenues and combination therapies.

Study objectivesWe previously presented results from a randomized controlled trial that examined the effects of antidepressant medication plus cognitive behavioral therapy for insomnia (CBT-I) among patients with major depressive disorder (MDD) and insomnia. The current secondary analysis aims to examine whether circadian preference moderated the reduction in depression and insomnia symptom severity during this trial.MethodsA total of 139 adult participants with MDD and insomnia disorder were treated with antidepressant medication and randomized to receive 7 sessions of CBT-I or a control therapy (CTRL). Circadian preference (eveningness) was measured using the Composite Scale of Morningness (CSM). Depression symptom severity was assessed using the Hamilton Depression Rating Scale (HDRS); insomnia symptom severity was assessed using the Insomnia Severity Inventory (ISI). The moderating role of circadian preference on changes in HRSD and ISI was assessed via latent growth models within the framework of structural equation modeling.ResultsGreater evening preference was associated with smaller reduction in HDRS (P = .03) from baseline to week 6 across treatment groups. The interaction between CSM and treatment group was also significant (P = .02), indicating that participants with greater evening preference in the CTRL group had significantly smaller HDRS reduction than those with greater evening preference in the CBT-I group. Circadian preference did not share significant associations with ISI (all P > .30).ConclusionsIndividuals with MDD and insomnia who have an evening preference are at increased risk for poor response to pharmacological depression treatment augmented with either CBT-I or CTRL behavioral insomnia treatment. However, evening types have better depression outcomes when treated with CBT-I than with CTRL for insomnia.

Felicia Forma,1 Tyler G Knight,2 Frances P Thorndike,1 Xiaorui Xiong,1 Rebecca Baik,2 Fulton F Velez,1 Yuri A Maricich,1 Daniel C Malone3 1Pear Therapeutics, Inc., Medical Affairs Department, Boston, MA, USA; 2Labcorp Drug Development, Market Access Consulting Department, Gaithersburg, MD, USA; 3Strategic Therapeutics, LLC, Oro Valley, AZ, USACorrespondence: Felicia Forma, Pear Therapeutics, Medical Affairs Department, 200 State St, Boston, MA, 02109, USA, Email felicia.forma@peartherapeutics.comBackground and Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I).Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018.Results: A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by => 7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score < 8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (− 53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P=0.389) and hospital outpatient visits (− 13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P=0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P=0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index (P= 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient.Conclusion: In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.Keywords: CBT-I, cognitive behavioral therapy for insomnia, chronic insomnia, prescription digital therapeutic, SHUTi, Somryst

Purpose of Review: The purpose of this review is to discuss the current evidence for Cognitive Behavioral Therapy for Insomnia (CBT-I) for patients with migraine and comorbid insomnia. In this article, we provide a narrative review of the literature on CBT-I and migraine, highlighting recent advances in research into this topic. Finally, we propose a way for clinicians to integrate CBT-I into clinical practice. Recent Findings: Multiple studies support CBT-I as a validated modality for the treatment of insomnia in migraine. Summary: CBT-I is used to treat insomnia and should be offered as first line therapy. Clinicians should screen for insomnia in all patients with headache, especially in those with migraine, to best manage this condition through the implementation of specific insomnia treatment. [ABSTRACT FROM AUTHOR]

Utilization of telehealth modalities to provide cognitive and behavioral therapies is rapidly increasing. Limitations to access to care can prohibit individuals from getting the care they need, especially evidence-based treatments. In the U.S., Veterans are a population in great need of accessible and high-quality evidence-based psychotherapy for insomnia, as it often co-occurs with other common syndromes such as depression and PTSD. Cognitive Behavioral Therapy for Insomnia (CBT-I) offers effective treatment for insomnia and can be delivered via telehealth and in a group format to greatly increase availability and accessibility. To date, however, few programs exist offering telehealth-to-home CBT-I, fewer still are offered in a primary care setting, and none to our knowledge are offered in group format. We examine the feasibility and efficacy of a fully telehealth-to-home (TTH) group CBT-I pilot program in primary care and compare primary outcomes to those seen in a face-to-face (F2F) format as well as meta-analytic studies of group CBT-I. Primary endpoints, as typically defined such as sleep efficiency (SE) and scores on the insomnia severity index (ISI) appear comparable to those seen in F2F groups in our clinic, and to outcomes seen in the literature. We discuss challenges and strategies for successful implementation of such a program in integrated primary care to increase access and availability of this evidence-based treatment. [ABSTRACT FROM AUTHOR]

Objective: This systematic review aims to evaluate the quality of intervention studies assessing CBT-I in adult populations with PTSD. Specifically examining overall quality, specific design elements and trends over time. Method: n > 1 studies assessing CBT-I in adult populations with PTSD were included. The Randomized Controlled Trial - Psychotherapy Quality Rating Scale (RCT-PQRS) was used to evaluate study quality. Correlations between overall study quality and publication year were calculated. Results: Nine studies were included. Overall, study quality was rated as moderate. Six design elements were not addressed adequately in most studies. No significant correlation was found. Conclusions: The evidence base is of moderate quality. However, several specific design elements limit their conclusions. Strategies to minimize limitations are discussed. [ABSTRACT FROM AUTHOR]

Background: Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD.Methods/design: We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes.Discussion: This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression.Trial Registration: ClinicalTrials.gov NCT03322774. Registered on October 26, 2017. [ABSTRACT FROM AUTHOR]