Investigating the subjective and objective efficacy of a cognitive behavioural therapy for insomnia (CBT-I)-based smartphone app on sleep: A randomised controlled trial.

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, ƞ2 part = 0.11) and PSQI (p = 0.050, ƞ2 part = 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.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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). TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR1900022699).

Dysfunctional beliefs and attitudes about sleep (DBAS) mediate outcomes in dCBT-I on psychological distress, fatigue, and insomnia severity.

OBJECTIVE/BACKGROUND: Digital cognitive behavioral therapy for insomnia (dCBT-I) improves several sleep and health outcomes in individuals with insomnia. This study investigates whether changes in Dysfunctional Beliefs and Attitudes about Sleep (DBAS) during dCBT-I mediate changes in psychological distress, fatigue, and insomnia severity. PATIENTS/METHODS: The study presents a secondary planned analysis of data from 1073 participants in a randomized control trial (Total sample = 1721) of dCBT-I compared with patient education (PE). Self-ratings with the Dysfunctional Beliefs and Attitudes about Sleep (DBAS), the Hospital Anxiety Depression Scale (HADS), the Chalder Fatigue Scale (CFQ), and the Insomnia Severity Index (ISI) were obtained at baseline and 9-week follow-up. Hayes PROCESS mediation analyses were conducted to test for mediation. RESULTS AND CONCLUSION: sDBAS scores were significantly reduced at 9-week follow-up for those randomized to dCBT-I (n = 566) compared with PE (n = 507). The estimated mean difference was -1.49 (95% CI -1.66 to -1.31, p < .001, Cohen's d. = 0.93). DBAS mediated all the effect of dCBT-I on the HADS and the CFQ, and 64% of the change on the ISI (Estimated indirect effect -3.14, 95% CI -3.60 to -2.68) at 9-week follow-up compared with PE. Changes in the DBAS fully mediated the effects of dCBT-I on psychological distress and fatigue, and the DBAS partially mediated the effects on insomnia severity. These findings may have implications for understanding how dCBT-I works and highlights the role of changing cognitions in dCBT-I.

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

STUDY OBJECTIVES: Numerous studies worldwide have reported the 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 6- and 12-months. The primary outcome was self-reported insomnia severity, assessed with the Insomnia Severity Index (ISI) at 8-weeks post-randomization. A one-way ANCOVA with baseline score as a covariate was fitted to determine group differences. Secondary outcomes included measures of daytime functioning, quality of life, depression, anxiety, dreams, and nightmares. RESULTS: Of the N = 238 participants (67.6% female), age range 19-81 years, n = 118 were randomized to dCBT-I and n = 120 to the control group. At posttreatment, the use of dCBT-I was associated with a large reduction in 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 a first-line treatment for insomnia.

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression.

PURPOSE: We conducted a rapid evidence review to explore the benefits and harms of digital cognitive-behavioral therapy (dCBT) and the barriers to and facilitators of implementing dCBT for adolescents. METHODS: We searched MEDLINE, PsycINFO, CENTRAL through December 6, 2021, for controlled trials conducted in settings highly applicable to the United States. Additionally, we searched relevant systematic reviews for eligible studies. Results were summarized qualitatively. RESULTS: We included 12 trials (n = 1,575) that examined the effects of nine dCBT programs. Overall, dCBT was slightly superior to comparators in improving depression symptoms immediately post-intervention, but not at a longer follow-up. The use of dCBT did not appear to result in an increased risk for suicidal attempts or ideation; however, the number of events was very small. Potential barriers to implementing/maintaining dCBT are challenges engaging/retaining patients, developing infrastructure, and training therapists to facilitate dCBT. Data on harms or unintended negative consequences were not reported in the included studies. CONCLUSIONS: A limited body of evidence suggests that dCBT programs might outperform control interventions for reducing depressive symptoms immediately post-intervention, but not at a longer follow-up. The safety of dCBT programs for adolescents with depression is understudied.