A multicountry study on the psychometric properties of the Arabic version of the Sleep Preoccupation Scale (SPS) using both classical testing theory and item response theory.

BACKGROUND: Sleep distrurbances involves daytime preoccupation about sleep, which plays a critical role in perpetuating sleep disturbances. Recent cognitive models highlight the importance of daytime processes, like processing sleep-related information and interpretations during waking hours, in influencing sleep quality and quantity. The Sleep Preoccupation Scale (SPS) quantifies this daytime cognitive activity related to sleep. This study aimed to translate and validate an Arabic version of the SPS for assessing sleep preoccupation among Arabic speakers. METHODS: 523 Arabic speakers (mean age 23.6 years, 75% female) from four countries completed the Arabic SPS alongside the Athens Insomnia Scale, Generalized Anxiety Disorder-7 Scale, and the Anxiety and Preoccupation about Sleep Questionnaire (APSQ). The sample repeated the SPS after two weeks for test-retest reliability. Confirmatory factor analysis evaluated the SPS's two-factor structure. Internal consistency, item response theory, and convergent validity with the other scales were examined. RESULTS: Confirmatory factor analysis supported the two-factor model's fit. Measurement invariance results suggest that the SPS exhibits a similar basic factor structure across both insomnia and non-insomnia groups. The Arabic SPS demonstrated good internal consistency (Cronbach's α = 0.92, McDonald's ω = 0.92) and two-way mixed effects, consistency, single rater/measurement intraclass correlation coefficient (ICC) test-retest reliability (ICC = 0.95). Most items exhibited satisfactory item response theory fit statistics and discrimination. The SPS total score showed strong positive correlations with insomnia severity (r = 0.48, p < 0.001), generalized anxiety (r = 0.57, p < 0.001), and sleep-related anxiety/preoccupation (r = 0.79, p < 0.001), demonstrating convergent validity. CONCLUSION: The Arabic version of the SPS demonstrated good psychometric properties and validity, supporting its use for assessing sleep preoccupation among Arabic speakers. This culturally-adapted version enhances sleep assessment capabilities for improving insomnia understanding and treatment within Arabic-speaking populations.

The Relationship Between Epidemic Perception and Cyberbullying Behaviors of Chinese Adolescents During the COVID-19 Pandemic: Cross-Sectional Study.

Background: In response to the COVID-19 outbreak, the government initiated measures for social distancing, leading to a gradual transition of adolescents' social interactions toward web-based platforms. Consequently, web-based behaviors, particularly cyberbullying, have become a prominent concern. Considering that adolescents experience more intense feelings, the widely increased negative emotions and strains perceived from the COVID-19 pandemic may end up engaging in cyberbullying behaviors. In addition, during the COVID-19 pandemic, adolescents experiencing insomnia and negative affect are more prone to diminished self-control, which is associated with cyberbullying behaviors. Objective: This study aims to investigate the relationship between epidemic perception and cyberbullying behaviors, while also examining the serial mediating roles of insomnia and negative affect on the relationship between epidemic perception and cyberbullying behaviors. Methods: This study presents a large-scale web-based survey conducted during the period of concentrated COVID-19 outbreaks, encompassing 20,000 Chinese adolescents. A total of 274 submitted questionnaires were discarded because of high levels of missing data or their answers were clearly fictitious or inconsistent. The final count of valid participants amounted to 19,726 (10,371 boys, age range: 12-18 years; mean 14.80, SD 1.63 years). The Perceptions of COVID-19 Scale, Negative Affect Scale, Insomnia Scale, and Cyberbullying Behavior Scale were used to assess participants' responses on the Questionnaire Star platform. Results: The results show that epidemic perception is positively correlated with cyberbullying behaviors (r=0.13; P<.001), insomnia (r=0.19; P<.001), and negative affect (r=0.25; P<.001). Insomnia is positively correlated with negative affect (r=0.44; P<.001) and cyberbullying behaviors (r=0.30; P<.001). Negative affect is positively correlated with cyberbullying behaviors (r=0.25; P<.001). And insomnia and negative affect play independent mediating and serial mediating roles in epidemic perception and cyberbullying behaviors. Conclusions: This study provides additional empirical evidence on the relationship between the perception of COVID-19 pandemic and cyberbullying in adolescents. In addition, the study offers recommendations for implementing interventions targeted at mitigating cyberbullying in adolescents during the COVID-19 pandemic.

Can Neuromodulation Improve Sleep and Psychiatric Symptoms?

PURPOSE OF REVIEW: In this review, we evaluate recent studies that employ neuromodulation, in the form of non-invasive brain stimulation, to improve sleep in both healthy participants, and patients with psychiatric disorders. We review studies using transcranial electrical stimulation, transcranial magnetic stimulation, and closed-loop auditory stimulation, and consider both subjective and objective measures of sleep improvement. RECENT FINDINGS: Neuromodulation can alter neuronal activity underlying sleep. However, few studies utilizing neuromodulation report improvements in objective measures of sleep. Enhancements in subjective measures of sleep quality are replicable, however, many studies conducted in this field suffer from methodological limitations, and the placebo effect is robust. Currently, evidence that neuromodulation can effectively enhance sleep is lacking. For the field to advance, methodological issues must be resolved, and the full range of objective measures of sleep architecture, alongside subjective measures of sleep quality, must be reported. Additionally, validation of effective modulation of neuronal activity should be done with neuroimaging.

Association between grit and insomnia: A population-based study.

BACKGROUND: This study aimed to investigate the association of the grit scale, a personality trait characterized by perseverance and passion, with both the presence and the severity of insomnia in the Korean adult population. METHODS: A nationwide population-based cross-sectional survey was conducted through face-to-face interviews using structured questionnaires between September and December 2018 in Korea. Grit was assessed by using the 8-item Short Grit Scale. Participants were categorized into insomnia and non-insomnia groups based on a threshold of 10 on the Insomnia Severity Index (ISI). The association between girt and insomnia was analyzed using multiple linear regression and multivariable logistic regression, controlling for sociodemographic factors, lifestyles, and comorbidities. RESULTS: A total of 2453 participants (49.9 % male; aged 19-92 years) were enrolled in the study. Individual grit scores ranged from 1.75 to 5.00 points (mean [SD], 3.27 [0.42]), and insomnia was present in 16.5 % of the population. The insomnia group exhibited lower grit score compared to the non-insomnia group (3.11 [0.40] vs. 3.30 [0.42], p < 0.001, Cohen's d = 0.46). Grit was negatively associated with ISI scores (ß = -0.15, 95 % CI = -0.19, -0.11, p < 0.001) and with having insomnia (OR 0.40, 95 % CI = 0.30, 0.55, p < 0.001), after controlling for covariates. CONCLUSIONS: Individuals with higher grit were less likely to have insomnia. Clinicians should consider personality traits, such as grit, in the evaluation and the management of insomnia.

Treatment of Depression-Related Circadian Rhythm Sleep-Wake Disorder (CRSWD) With Melatonin Receptor Agonist Ramelteon: A Case Report.

Insomnia, also called sleeplessness, is a sleep disorder with very diverse sleep problems and is classified into seven categories. Circadian rhythm sleep-wake disorder (CRSWD) is a type of insomnia characterized by the misalignment of the body's circadian clock with the external 24-hour environmental cycle. CRSWD encompasses seven subtypes, among which delayed sleep-wake phase disorder (DSWPD) is prominently recognized for its impact on sleep patterns. Sleep disturbances, particularly insomnia, are prevalent in depressed patients, often serving as a primary symptom that prompts clinical consultation. CRSWD frequently leads to significant social dysfunction, often making it impossible for students to attend school and difficult for working adults to find employment. Effective treatments for CRSWD include bright light therapy, cognitive-behavioral therapy for insomnia (CBT-I), and melatonin receptor agonists, particularly for certain CRSWD subtypes. In this case report, the melatonin receptor agonist ramelteon was administered to a high school student with DSWPD and comorbid depression, resulting in the successful management of symptoms. Following treatment, the patient resumed high school, pursued a university education, and secured employment post-graduation. These findings indicate that ramelteon may be a promising treatment option for CRSWD in patients with comorbid depression, warranting further clinical investigation.

The mediating roles of psychological resilience and psychological well-being of caregivers for the older adults.

Objective: This study aimed to investigate the mediating effects of psychological resilience and psychological well-being for caregivers at nursing homes on the relationship between insomnia and elder maltreatment. As the world is aging quickly and the number of older individuals cared for by formal caregivers has been increasing, this study's results could help create intervention programs to minimize the occurrence of older people's maltreatment. Materials and Methods: A total of 431 care workers who met all criteria, from 21 care service centers for older adults in Fukuoka, Japan, completed the Conditions of Maltreatment Scale, Caregivers' Belief in Ideal Care, Insomnia Severity Index, WHO-5 Well-Being Index, and Connor-Davidson Resilience Scale-10. Results: A multivariate analysis of variance revealed that participants with no insomnia had greater resilience, higher psychological well-being, and greater belief in ideal care and to treated older clients less roughly compared to participants with insomnia. Psychological resilience and well-being were significant mediators in the relationship between insomnia, rough care, and beliefs in ideal care. Conclusion: As formal caregivers are in urgent demand, society should take care of them. The most effective and successful intervention for improving their physical and psychological well-being should be initiated at the individual and organizational levels.

Sleepless in the Pursuit of perfection: A longitudinal investigation of bidirectional relationships between insomnia and perfectionism in Adolescent males and females.

STUDY OBJECTIVES: Perfectionism is a possible risk factor for insomnia, yet longitudinal evidence of this relationship in adolescence is lacking. Cross-sectional evidence suggests the nature of the relationship may differ based on biological sex, and the form of perfectionism, since socially prescribed and self-oriented critical perfectionism are conceptualised as maladaptive for wellbeing, while self-oriented striving may be adaptive or neutral. This study aimed to investigate longitudinal bidirectional relationships between total perfectionism, and sub-forms of perfectionism (i.e., socially prescribed, self-oriented critical, self-oriented striving perfectionism), and symptoms of insomnia, over the course of mid-adolescence. Longitudinal models were examined for males and females separately. METHODS: 434 adolescents (Mage = 14.25, SD = 0.56, range = 13-16, 52 % male) completed questionnaire measures of perfectionism (Child-Adolescent Perfectionism Scale) and insomnia (Insomnia Severity Index) on three annual occasions (at approximately 14, 15 & 16 years of age). Data were from the larger Risks to Adolescent Wellbeing (RAW) Project. RESULTS: Biological sex did not moderate the association between insomnia symptoms and any form of perfectionism. Cross-lagged panel models showed no longitudinal relationship between self-oriented striving, nor self-oriented critical perfectionism and insomnia symptoms for males or females. Higher total perfectionism predicted moderate increases in insomnia symptoms for males and females, but insomnia symptoms did not predict changes in total perfectionism. Socially prescribed perfectionism and insomnia symptoms predicted large and moderate increases in one another over time, respectively, forming a perpetuating cycle. CONCLUSIONS: Results suggest that perfectionism may be an important risk factor for insomnia symptoms in adolescents.

Screening for Psychiatric Disorders in Chronic Rhinosinusitis Patients Waiting for Surgery: A Prospective Cross-Sectional Study.

OBJECTIVE: To assess the prevalence of depression, anxiety, insomnia and somatic symptom disorder (SSD) in chronic rhinosinusitis (CRS) patients who were waiting for surgery and to predict these psychiatric disorders using the 22-item Sinonasal Outcome Test (SNOT-22). DESIGN: A prospective cross-sectional study. SETTING: The rhinology ward at our institution, a tertiary hospital. PARTICIPANTS: Adult patients (> 18 years) diagnosed with CRS who were admitted to the rhinology ward for endoscopic sinus surgery and were able to understand and complete the study questionnaires. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Insomnia Severity Index (ISI), Patient Health Questionnaire-15 (PHQ-15) and SNOT-22. RESULTS: Of the 159 participants recruited, 58 were at risk of depression (defined by PHQ-9 > 4, while 25 with PHQ-9 > 9), 49 were at risk of anxiety (defined by GAD-7 > 4, while 25 with GAD-7 > 9), 81 were at risk of insomnia (defined by ISI > 7, while 51 with ISI > 14) and 69 were at risk of SSD (defined by PHQ-15 > 4, while 24 with PHQ-15 > 9). The SNOT-22 score was closely correlated with the scores of psychometric tests and was an independent predictor of these psychiatric disorders. Patients with a high SNOT-22 score (> 30) are likely to be affected by comorbid psychiatric disorders and should be further evaluated by otolaryngologists. CONCLUSION: Depression, anxiety, insomnia and SSD are prevalent in CRS patients. Otolaryngologists should have a low threshold to ask the patient about psychiatric symptoms, especially for patients with an SNOT-22 score > 30.

Depressive symptoms in patients with hypersomnia measured with Beck Depression Inventory.

BACKGROUND: Patients with central hypersomnia (HCO) often show symptoms of depression. Despite of many studies conducted in this field, the link between these two disorders remains unclear. In order to contribute data to this research, we examined the question of which depressive symptoms characterize these patients. Furthermore, we investigated the differences between HCO who were more or less depressed regarding insomnia, sleep quality and daytime tiredness. METHODS AND MATERIAL: The retrospective analysis assesses the presence and kind of depressive symptoms as measured by the Beck Depression Inventory (BDI) in 168 HCO including narcolepsy type I (NAR1), narcolepsy type II (NAR2) and idiopathic hypersomnia (HYP). Sleep parameters from one night of polysomnography, scores of questionnaires for insomnia and for daytime sleepiness, and data from sustained attention tests were compared between HCO with and without depression, as determined by BDI scores (cut off >12). RESULTS: According to BDI scores 52% exhibited no depression. The BDI items pertaining to tiredness and work inhibition exhibited elevated scores, whereas those pertaining to suicidality showed low scores. No difference was found between depressed and non-depressed HCO with regard to daytime vigilance performance or daytime sleepiness. However, depression was associated with older age, higher insomnia scores, and a shorter sleep time on polysomnography. CONCLUSION: A potential interpretation of our findings is that depressive symptoms in HCO may be a consequence of restricted life quality due to hypersomnia. Thus, therapeutical effort should focus more intensely on coping strategies.

Promoting sustained access to cognitive behavioral therapy for insomnia in Australia: a system-level implementation program.

STUDY OBJECTIVES: Insomnia is a highly prevalent and debilitating disorder. Cognitive behavioral therapy for insomnia (CBTi) is the recommended 'fist line' treatment, but is accessed by a minority of people with insomnia. This paper describes a system-level implementation program to improve access to CBTi in Australia to inform CBTi implementation in other locations. METHODS: From 2019 to 2023, we conducted a program of work to promote sustained change in access to CBTi in Australia. Three distinct phases included 1) Scoping and mapping barriers to CBTi access, 2) Analysis and synthesis of barriers and facilitators to devise change goals, and 3) Structured promotion and coordination of change. We used a system-level approach, knowledge brokerage, and co-design, and drew on qualitative, quantitative, and implementation science methods. RESULTS: We identified barriers to CBTi access from the perspectives of people with insomnia, primary care clinicians, and the health system. A stakeholder advisory committee was convened to co-design change goals, identify modifiable barriers, devise program logic and drive change strategies. We commenced a program to promote system-level change in CBTi access via; improved awareness and education of insomnia among primary care clinicians, self-guided interventions, and advocating to Government for additional CBTi funding mechanisms. CONCLUSIONS: This implementation program made significant progress toward improving access to CBTi in Australia. Ongoing work is required to continue this program, as long-term system-level change requires significant and sustained time, effort and resources from multiple stakeholders. This program may be used to inform CBTi implementation activities in other locations.

Applicability of a digital health application for cancer patients: a qualitative non-participation analysis.

BACKGROUND: The use of digital health applications (German acronym DiGA) for comprehensive patient care is increasing rapidly. Patients with non-organic insomnia can be prescribed an application to manage insomnia. Due to the high prevalence of insomnia in patients with cancer, we were interested in the effect of it and what barriers need to be overcome for its use. The focus of existing studies on acceptance and benefits prompted us to emphasise the analysis of barriers and thus to formulate possible solutions. METHODS: To analyse the barriers of use, the study population (patients with self-reported tiredness or sleep disturbance via validated instruments and cancer disease) was divided into 3 groups. In groups 1 (patients who refused to participate in advance) and 2 (patients who refused a prescription), short close-ended questionnaires were used for non-response assessment by treating oncologists. Problem-centred guidelines were used for the telephone interviews with group 3 (patients who did not provide information on DiGA use). Alternatively, group 3 was invited to complete and return the close-ended questionnaire. A quantitative analysis of the non-response reasons was conducted using SPSS in groups 1 and 2, while MAXQDA was used for the qualitative data in group 3. RESULTS: Patients refused to participate at several stages of our study. Quantitative data are available for groups 1 and 2. In the largest group 1, 62% of patients refused to participate due to non-subjective sleep disturbance (177 out of 189 patients) during recruitment by treating oncologists, despite high scores on the screening tool. In the small group 2 (11 out of 15), the most common reasons for withdrawal documented by the oncologists were loss of interest and deteriorating health. The problem-centred qualitative interviews with group 3 (17 patients) revealed that some of them used the prescribed DiGA, despite not being included in the main study and being categorized as lost to follow-up. CONCLUSION: Analysis of barriers to DiGA use showed that reducing administrative barriers and providing digital and personal support can increase acceptance of the use of DiGAs among cancer patients. Additionally, screening tools can act as a door opener to further communication regarding DiGAs. TRIAL REGISTRATION: German Register of Clinical Trials DRKS00034198, registration date: 7/05/24 (retrospectively registered).

Clinical and financial significance of insomnia within a large payor-provider health system.

Study Objectives: Insomnia has profound negative effects on behavioral health, physical health, and functional domains. Leveraging claims data from one of the nation's largest payor-provider systems, the current study examined the real-world prevalence of insomnia, comorbidity of insomnia with behavioral health and other sleep disorders, and the impact of insomnia on total health care costs. Methods: Prevalence and costs associated with insomnia were assessed by examining claims data on approximately 3 million insured members during the year 2022. Using propensity score matching, total health care expenditures were calculated and compared for members with insomnia relative to matched cohorts without insomnia. Generalized linear modeling tested for differences between the cohorts. Results: Nine percent of members were identified as having insomnia; 64% of those also had depression, anxiety, and/or substance use disorder. Median total health care costs among individuals with insomnia were 4-6 times greater than among those without insomnia. A disproportionate amount (21.1%) of total claims spend came from members with insomnia. Conclusions: Findings demonstrate a high degree of clinical need and behavioral health comorbidity associated with insomnia within a large insured cohort. Beyond the clinical significance, the current results demonstrate substantial financial need and opportunity for adequately treating insomnia. This is especially the case for the high proportion of members with insomnia and cooccurring depression, anxiety, and/or substance use disorders. Overall, the findings point to the important role payors and providers may have in promoting greater attention to sleep and insomnia.

Efficacy of non-pharmacological interventions on sleep quality in patients with cancer-related insomnia: a network meta-analysis.

Objective: Despite the widespread application of non-pharmacological therapies in treating cancer-related insomnia, a comprehensive assessment of these methods is lacking. This study aims to compare the efficacy of 11 non-pharmacological interventions for cancer-related insomnia, providing a theoretical basis for clinicians in choosing treatment methods. Methods: We searched five databases, including the Cochrane Central Register of Controlled Trials, PubMed, Embase, Wiley Library, and Web of Science, for relevant randomized controlled trials. Included studies involved patients diagnosed with cancer-related insomnia, employed non-pharmacological treatments, and reported outcomes using the PSQI and ISI. Bayesian statistical methods were used for the network meta-analysis, and statistical processing was performed using Review Manager 5.4 and Stata 14.0 software. The results were thoroughly analyzed and evaluated, and publication bias was assessed using funnel plot tests. Results: Our study included 41 randomized controlled trials, comprising 11 different non-pharmacological interventions (3,541 participants), the network analysis identifying Electroacupuncture as the most effective, with a SUCRA value of 92.2% in ISI, this was followed by Professionally administered Cognitive behavioral therapy for insomnia(PCBT-I) and Mindfulness-based cognitive therapy(MBCT), with SUCRA values of 78.4 and 64.1%, respectively. Traditional Cognitive behavioral therapy for insomnia(CBT-I) and VCBT-I showed lower efficacy with SUCRA values of 55.9 and 55.2%, respectively. Exercise interventions and control groups had the lowest efficacy, with SUCRA values of 24.0 and 16.1%. Using PSQI as the outcome measure, Massage therapy ranked highest in improving sleep quality with a SUCRA value of 92.2%, followed by Professionally administered Cognitive behavioral therapy for insomnia (PCBT-I) and Electroacupuncture. League tables indicated significant improvements in sleep outcomes for Electroacupuncture and MT compared to control groups, with Electroacupuncture (EA) showing an MD of -7.80 (95% CI: -14.45, -1.15) and MT an MD of -4.23 (CI: -8.00, -0.46). Conclusion: Considering both outcome indicators, Electroacupuncture was significantly effective in alleviating the severity of insomnia, while MT was most effective in improving sleep quality. Therefore, in the non-pharmacological interventions for cancer-related insomnia, Electroacupuncture and MT May be particularly effective choices. Future research should further explore the specific mechanisms of action of these interventions and their efficacy in different patient groups.

Maternal early pregnancy body mass index and risk of insomnia in the offspring.

STUDY OBJECTIVES: To investigate the association between maternal early pregnancy body mass index (BMI) and risk of offspring insomnia. METHODS: We conducted a nationwide cohort study among 3,281,803 singleton live births in Sweden born 1983-2015. Using national registries with prospectively recorded information, we followed participants for an insomnia diagnosis from 2 to up to 35 years of age. We compared insomnia risks by early pregnancy BMI categories using hazard ratios (HR) with 95% confidence intervals (CI) from adjusted Cox models. To assess unmeasured shared familial confounding, we conducted sibling-controlled analyses among 1,724,473 full siblings and studied the relation of maternal full sisters' BMI and insomnia risk in 1,185,998 offspring. RESULTS: There were 7,154 insomnia diagnoses over a median follow-up age of 17.9 years. Compared with women with normal BMI, adjusted HR (95% CI) of offspring insomnia for early pregnancy BMI categories overweight, obesity class I, and obesity classes II or III were, respectively, 1.22 (1.14, 1.30), 1.60 (1.45, 1.77), and 2.11 (1.83, 2.45). Corresponding adjusted HR (95% CI) in sibling comparisons were, respectively, 1.32 (1.05, 1.65), 1.48 (1.03, 2.14), and 1.56 (0.91, 2.65). Associations with maternal sisters' BMI were attenuated, suggesting a weak role for unmeasured shared factors. Other pregnancy, birth, and neonatal complications were associated with risk of insomnia in offspring but did not substantially mediate the association. CONCLUSIONS: The dose-response relation between maternal overweight and obesity severity with offspring insomnia risk is not fully explained by shared familial factors.

A double-layered fully automated insomnia identification model employing synthetic data generation using MCSA and CTGAN with single-channel EEG signals.

Insomnia was diagnosed by analyzing sleep stages obtained during polysomnography (PSG) recording. The state-of-the-art insomnia detection models that used physiological signals in PSG were successful in classification. However, the sleep stages of unbalanced data in small-time intervals were fed for classification in previous studies. This can be avoided by analyzing the insomnia detection structure in different frequency bands with artificially generated data from the existing one at the preprocessing and post-processing stages. Hence, the paper proposes a double-layered augmentation model using Modified Conventional Signal Augmentation (MCSA) and a Conditional Tabular Generative Adversarial Network (CTGAN) to generate synthetic signals from raw EEG and synthetic data from extracted features, respectively, in creating training data. The presented work is independent of sleep stage scoring and provides double-layered data protection with the utility of augmentation methods. It is ideally suited for real-time detection using a single-channel EEG provides better mobility and comfort while recording. The work analyzes each augmentation layer's performance individually, and better accuracy was observed when merging both. It also evaluates the augmentation performance in various frequency bands, which are decomposed using discrete wavelet transform, and observed that the alpha band contributes more to detection. The classification is performed using Decision Tree (DT), Ensembled Bagged Decision Tree (EBDT), Gradient Boosting (GB), Random Forest (RF), and Stacking classifier (SC), attaining the highest classification accuracy of 94% using RF with a greater Area Under Curve (AUC) value of 0.97 compared to the existing works and is best suited for small datasets.

Smartphone application-delivered cognitive behavioural therapy for insomnia with telephone support for insomnia disorder compared to a waitlist control: a randomised clinical trial.

Although there have been promising findings for smartphone application (app)-delivered cognitive behavioural therapy for insomnia (CBT-I), previous trials have not screened participants rigorously for insomnia disorder and used therapist support. Based on the above, we aimed to examine the effects of smartphone app-delivered CBT-I with telephone support against a waitlist (WL) in a sample with insomnia disorder. A total of 64 participants with insomnia disorder were randomised to smartphone app-delivered CBT-I (n = 32) or a WL (n = 32). Smartphone app-delivered CBT-I consisted of six weekly smartphone app modules with 15 min of telephone support per week. At pre- and post-treatment, and the 3-month follow-up, we assessed insomnia symptoms and associated correlates and consequences. At post-treatment, we also assessed measures related to adherence (therapist support, exercise/module completion), self-rated perception of treatment content, activity, and adverse events. CBT-I significantly outperformed the WL with large effects on the primary outcome (d = 2.26) and was significantly different on most of the secondary outcomes with medium to large effects. CBT-I also resulted in a significantly larger proportion of treatment remitters (CBT-I: 64.5-77.4%, WL: 6.5-6.9%) and responders (CBT-I: 77.4-90.3%, WL: 19.4-24.1%) at post-treatment and follow-up, compared to the WL. Treatment was associated with high satisfaction, high adherence, low attrition, and few treatment-impeding adverse events. Based on the medium to large effects of smartphone app-delivered CBT-I with telephone support, this trial highlights the potential of delivering CBT-I exclusively through an app with therapist telephone support for high efficacy, satisfaction, and adherence.

Senegenin regulates the mechanism of insomnia through the Keap1/Nrf2/PINK1/Parkin pathway mediated by GAD67.

GAD67 impacts insomnia as a key enzyme catalysing the conversion of glutamate (Glu) to gamma-aminobutyric acid (GABA). Senegenin enhances neuroprotection and is used widely to treat insomnia and other neurological diseases. This study aimed to investigate how senegenin regulates insomnia through a GAD67-mediated signalling pathway. We measured GAD67 expression levels in insomnia patients and evaluated the expression levels of GAD67 and Keap1/Nrf2/Parkin/PINK1-related cytokines following GAD67 lentiviral transfection in PC12 cells and in rat models. We also assessed cellular reactive oxygen species (ROS) and mitochondrial membrane potential levels. Additionally, EEG/EMG was used to analyse the sleep phases of rats and to assess memory and exploration functions. Pathological changes and the expression of GAD67 and sleep-related proteins in the hippocampus were examined. The results showed that GAD67 expression was increased in insomnia patients, ROS levels were elevated, and the mitochondrial membrane potential was decreased in the GAD67-KD group. Insomnia rats exhibited changes in sleep rhythm, learning, and exploration dysfunction, pathological changes in the CA1 region of the hippocampus, and differential expression of GAD67 and sleep-related factors. Inhibitory neurofactor expression levels were decreased in insomnia rats, showing a positive correlation in the GAD67-KD group and a negative correlation in the GAD67-OE group. Conversely, excitatory factor expression levels were increased in insomnia rats, showing a positive correlation in the GAD67-KD group and a negative correlation in the GAD67-OE group. Senegenin intervention modulated cytokine expression levels. In conclusion, GAD67 negatively regulates insomnia, and senegenin can regulate insomnia by mediating the expression of cytokines in the GAD67-regulated Keap1/Nrf2/Parkin/PINK1 pathway.

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.

The effect of MIND diet on sleep status, anxiety, depression, and cardiometabolic indices in obese diabetic women with insomnia: study protocol for a randomized controlled clinical trial {1}.

BACKGROUND: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators. METHODS: Forty-four overweight/obese T2DM women with insomnia, aged 30-65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed. DISCUSSION: The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions. TRIAL REGISTRATION: IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772.