STUDY OBJECTIVES
Numerous studies worldwide have reported beneficial effects of digital cognitive behavioral therapy for insomnia (dCBT-I). However, few focus on real-world study samples that reflect people in regular care. To test whether dCBT-I is suitable within German regular care, we designed a randomized controlled trial recruiting a heterogenous insomnia population.


METHODS
Participants aged 18+ who met the criteria for insomnia disorder were randomized to 8-weeks dCBT-I + care-as-usual (CAU) or they were set on a waitlist + CAU. The intervention group was followed up at six and 12-months. Primary outcome was self-reported insomnia severity, assessed with the Insomnia Severity Index (ISI) at eight-weeks post-randomization. A one-way ANCOVA with baseline score as covariate was fitted to determine group-differences. Secondary outcomes included measures on daytime functioning, quality of life, depression, anxiety, dreams, and nightmares.


RESULTS
Of the N = 238 participants (67.6% female), age range 19 to 81 years, n = 118 were randomized to dCBT-I and n = 120 to the control group. At post-treatment, the use of dCBT-I was associated with a large reduction on the ISI (Diffadj = -7.60) in comparison to WLC (d = - 2.08). This clinical improvement was also reflected in responder and remission rates. Treatment effects were also observed for daytime functioning, quality of life, symptoms of depression and anxiety (ds = 0.26 - 1.02) and at long-term follow-up (intervention group only; ds = 0.18 - 1.65). No effects were found for dream and nightmare frequency.


CONCLUSIONS
This study showed that dCBT-I reduces insomnia symptoms and improves daytime functioning in a heterogenous insomnia population in Germany with sustained long-term treatment effects in the intervention group. Our results underscore the potential of digital health applications, their suitability within regular care, and their role in facilitating widespread implementation of CBT-I as first-line treatment for insomnia.

The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: Results from a randomized controlled trial.

Background. Sleep disturbances are commonly reported, although underestimated complaints from people with multiple sclerosis (MS). The aim of the study was to analyze the frequency and type of sleep disturbances in MS patients and to evaluate their relationships with demographics and clinical data. Methods. The study group consisted of 178 patients with relapsing-remitting MS: 130 females and 48 males. Clinical measures (disease duration, disability level in Expanded Disability Status Scale (EDSS), and treatment) were acquired from medical records. The questionnaire was applied, containing questions about sleep disturbances, somatic complaints, perception of fatigue, depression, anxiety, and problems at work and in social/family life. Athens Insomnia Scale (AIS) and Karolinska Sleepiness Scale (KSS) were performed to quantify sleep problems and Hamilton Depression Rating Scale (HDRS) and Addenbrooke’s Cognitive Examination (Mini-ACE) to assess level of depression and cognitive performance. Electroencephalography was recorded to identify electrophysiological indices of sleep. Results. 109 patients (61%) reported sleep disturbances, most frequently insomnia, snoring, and parasomnias. This subgroup had significantly higher scores in AIS (p<0.0001) and KSS (p=0.010) and slightly higher EDSS score (p=0.048) and more often complained of fatigue (71% vs. 53%, p=0.0148), involuntary limb movement (42% vs. 25, p=0.0170), and breathing disturbances (10% vs. 0%). There was a significant correlation between the results of AIS and HDRS (Rs=0.715, p<0.05). Conclusion. Sleep disturbances, predominantly insomnia, are reported by more than a half of the patients with relapsing-remitting MS. Significant associations were found between sleep problems and MS-related clinical symptoms and psychosocial issues.

Sleep Disturbance and Related Factors in the Patients with Relapsing-Remitting Multiple Sclerosis

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. 

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

Disturbed sleep is prevalent after corona virus disease (COVID-19). However, little is known of post infectious prevalence, course, predictors and treatment of chronic insomnia. 

Prevalence of insomnia and feasibility of a nurse-administered digital cognitive behavioural therapy two years after corona virus disease hospitalisation

Background Doxepin, an antidepressant commonly prescribed for the management of depression and insomnia, has been insufficiently explored regarding its safety. We aimed to determine the overall safety profile of doxepin and evaluate relevant adverse events of special interest (AESIs). Methods Utilizing the World Health Organization’s VigiBase from 1967 to 2022, we conducted a disproportionality analysis for AESIs associated with doxepin compared with other tricyclic antidepressants. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were estimated using multivariable logistic regression analysis. Signals were regarded significant when they met the following criteria: cases ≥ 3, and lower end of the 95% CI of ROR ≥ 1. Results Of the 6,827 doxepin-related reports, 3,869 (56.67%) were predominantly reported in women, with a substantial proportion from the middle-aged population. Overall, none of the predefined AESIs met the safety criteria for this analysis. However, among the frequently reported adverse events (AEs) following doxepin administration, safety signal was identified for drug abuse (adjusted ROR, 2.41; 95% CI, 2.06–2.83). Conclusion Although no definitive safety signals were detected in our AESI analyses, we identified safety signal for drug abuse. Clinicians should carefully weigh the risks and benefits when prescribing doxepin and emphasize the need for vigilant monitoring of AEs.

Psychological Adverse Events and Associated Safety Profiles of Doxepin: A Pharmacovigilance Study Using VigiBase

Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting.The study included 6,002 patients aged 18 years and above with primary complaints of dissatisfying sleep from a sleep clinic in a psychiatric hospital from November 2016 to April 2021. Patients were diagnosed with insomnia, anxiety disorders, or anxiety comorbid with insomnia or depression according to ICD-10. A mobile app was developed for self-reported assessment and delivering dCBT-I interventions and treatment prescriptions to participants. The primary outcome was change in global sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). At 8- and 12-week follow-up, 509 patients were reassessed. Data were analyzed with non-parametric tests for repeated measures.Patients treated with dCBT-I monotherapy were younger, with a more frequent family history of insomnia compared to those with medication monotherapy and those with combined dCBT-I and medication therapy. Improvements of sleep quality from baseline to 8-week follow-up were significant in each treatment type. Compared to 8-week follow-up, PSQI scores at 12-week were significantly decreased in the depression group receiving combined therapy and in the anxiety group treated with dCBT-I monotherapy and with combined therapy. A time-by-treatment interaction was detected in anxiety patients indicating differential reduction in PSQI scores over time between different treatment options.The current findings suggest dCBT-I is a practical and effective approach for lessening insomnia symptoms, especially for patients with anxiety symptoms suggesting with a more extended intervention period (i.e., 12 weeks).Chinese Clinical Trial Registry (ChiCTR1900022699). 

/pdf/digital-cognitive-behavior-therapy-for-insomnia-improving-1z433ku3.pdf

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study

Abstract This study aims to explore the factors that affect the prognosis of patients with insomnia who are treated with mobile cognitive behavioral therapy. Patients with insomnia who visited the sleep disorders clinic were selected and completed mobile Cognitive behavioral therapy. Patients completed at least three evaluations (including baseline, monthly evaluations thereafter, and a final evaluation at the end of one year) and responded well to treatment within one year of follow-up. Insomnia, anxiety, and depression symptoms were evaluated using the Pittsburgh Sleep Quality Index (PSQI), the Generalized Anxiety Disorder 7-item (GAD-7) scale, and the 9-item Patient Health Questionnaire (PHQ-9), respectively. Treatment prognosis including relapse, recurrence, and remission group. These 339 patients were divided into three groups: 160 patients who remission, 100 patients who relapsed, and 79 patients who experienced recurrence after remission. Demographic characteristics of the 339 patients showed no significant difference in gender between the three groups ( P = 0.978). However, significant differences were found in age ( P = 0.006) and onset time (P = 0.000) among the three groups. The remission group had a higher average age than the recurrence group and the relapse group, and the onset time was slower than the other two groups. Multivariate logistic regression analysis showed that age and delayed onset time were protective factors for good treatment prognosis, while low educational level and high GAD-7 scores were independent risk factors for poor prognosis. There are many factors that affect the treatment prognosis of insomnia. Age, low educational level, high GAD-7 scores, and delayed onset time can be used to predict the prognosis of insomnia treatment. 

Mobile cognitive behavioral therapy for insomnia: analysis of factors affecting treatment prognosis

Background Factors affecting subjective perception of sleep are unclear but clinically important. We investigated the differences in subjective sleep perception of patients with obstructive sleep apnea (OSA) and insomnia disorder (ID). Material/Methods From our Sleep Medicine Center database, 33 patients with OSA and 69 with ID were selected and assessed with the Pittsburgh Sleep Quality Index (PSQI), Generalized Anxiety Disorder screen, Patient Health Questionnaire-9, Epworth Sleepiness Scale, Pre-sleep Arousal Scale (PSAS), and polysomnography. Results In subjective sleep tests, PSQI total score, sleep quality, sleep onset latency (SOL), total sleep time, and sleep efficiency (SE) were higher in patients with ID. In objective sleep tests, patients with OSA had longer total sleep time, shorter SOL, lower percentage of stage N3, less SE, higher percentage of stage N1, more arousals, and higher arousal index. Hyperarousal state evaluation showed cognitive hyperarousal significantly higher with ID. Subjective sleep perception with OSA correlated positively with PSAS total score, cognitive hyperarousal, and percentage of stage N2 and negatively with percentage of REM, apnea-hypopnea index, and desaturation index. Subjective sleep perception of patients with ID correlated positively with PSAS total score, cognitive hyperarousal, SOL, N3 sleep latency, and REM sleep latency and negatively with SE. Conclusions Subjective sleep perception of OSA patients was mainly related to sleep structure and respiratory events, and that of ID patients, to sleep latency. Individual cognitive hyperarousal levels may be involved in negative subjective sleep perception. Clinicians should be aware that OSA patients may not actually experience adequate sleep.

Discordant Subjective Perception of Sleep in Patients with Obstructive Sleep Apnea and Insomnia: A Retrospective Study

Author Correction: Mobile cognitive behavioral therapy for insomnia: analysis of factors affecting treatment prognosis

Doxepin is more effective than zolpidem in improving executive function in patients with insomnia disorder.

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