Fully automated digital interventions delivered via smartphone apps have proven efficacious for a wide variety of mental health outcomes. An important aspect is that they are accessible at a low cost, thereby increasing their potential public impact and reducing disparities. However, a major challenge to their successful implementation is the phenomenon of users dropping out early.

The purpose of this study was to pinpoint the factors influencing early dropout in a sample of self-selected users of a virtual agent (VA)-based behavioral intervention for managing insomnia, named KANOPEE, which is freely available in France.

From January 2021 to December 2022, of the 9657 individuals, aged 18 years or older, who downloaded and completed the KANOPEE screening interview and had either subclinical or clinical insomnia symptoms, 4295 (44.5%) dropped out (ie, did not return to the app to continue filling in subsequent assessments). The primary outcome was a binary variable: having dropped out after completing the screening assessment (early dropout) or having completed all the treatment phases (n=551). Multivariable logistic regression analysis was used to identify predictors of dropout among a set of sociodemographic, clinical, and sleep diary variables, and users' perceptions of the treatment program, collected during the screening interview.

The users' mean age was 47.95 (SD 15.21) years. Of those who dropped out early and those who completed the treatment, 65.1% (3153/4846) were women and 34.9% (1693/4846) were men. Younger age (adjusted odds ratio [AOR] 0.98, 95% CI 0.97-0.99), lower education level (compared to middle school; high school: AOR 0.56, 95% CI 0.35-0.90; bachelor's degree: AOR 0.35, 95% CI 0.23-0.52; master's degree or higher: AOR 0.35, 95% CI 0.22-0.55), poorer nocturnal sleep (sleep efficiency: AOR 0.64, 95% CI 0.42-0.96; number of nocturnal awakenings: AOR 1.13, 95% CI 1.04-1.23), and more severe depression symptoms (AOR 1.12, 95% CI 1.04-1.21) were significant predictors of dropping out. When measures of perceptions of the app were included in the model, perceived benevolence and credibility of the VA decreased the odds of dropout (AOR 0.91, 95% CI 0.85-0.97).

As in traditional face-to-face cognitive behavioral therapy for insomnia, the presence of significant depression symptoms plays an important role in treatment dropout. This variable represents an important target to address to increase early engagement with fully automated insomnia management programs. Furthermore, our results support the contention that a VA can provide relevant user stimulation that will eventually pay out in terms of user engagement.

Increasing evidence suggests that insomnia plays an important role in the development of depression, supporting insomnia intervention as a promising approach to prevent depression in youth. This randomized controlled trial evaluated the effectiveness of app-based cognitive behavioral therapy for insomnia (CBT-I) in preventing future onset of major depressive disorder (MDD) in youth.

This was a randomized, assessor-blind, parallel group-controlled trial in Chinese youth (aged 15-25 years) with insomnia disorder and subclinical depressive symptoms. Participants were randomly assigned (1:1) to 6-week app-based CBT-I or 6-week app-based health education (HE) delivered through smartphones. Online assessments and telephone clinical interviews were conducted at baseline, post-intervention, 6- and 12-month follow-ups. The primary outcome was time to onset of MDD. The secondary outcomes included depressive symptoms and insomnia at both symptom and disorder levels. Between September 9, 2019, and November 25, 2022, 708 participants (407 females [57%]; mean age, 22.1 years [SD = 1.9]) were randomly allocated to app-based CBT-I group (n = 354) or app-based HE group (n = 354). Thirty-seven participants (10%) in the intervention group and 62 participants (18%) in the control group developed new-onset MDD throughout the 12-month follow-up, with a hazard ratio of 0.58 (95% confidence interval 0.38-0.87; p = 0.008). The number needed to treat to prevent MDD at 1 year was 10.9 (6.8-26.6). The app-based CBT-I group has higher remission rates of insomnia disorder than the controls at post-intervention (52% versus 28%; relative risk 1.83 [1.49-2.24]; p < 0.001) and throughout 12-month follow-up. In addition, the CBT-I group reported a greater decrease in depressive (adjusted difference -1.0 [-1.6 to -0.5]; Cohen's d = 0.53; p < 0.001) and insomnia symptoms (-2.0 [-2.7 to -1.3], d = 0.78; p < 0.001) than the controls at post-intervention and throughout 6-month follow-up. Insomnia was a mediator of intervention effects on depression. No adverse events related to the interventions were reported.

App-based CBT-I is effective in preventing future onset of major depression and improving insomnia outcomes among youth with insomnia and subclinical depression. These findings highlight the importance of targeting insomnia to prevent the onset of MDD and emphasize the need for wider dissemination of digital CBT-I to promote sleep and mental health in the youth population.

ClinicalTrials.Gov (NCT04069247).

Mental health apps are efficacious, yet they may pose risks in some. This review (CRD42024506486) examined adverse events (AEs) from mental health apps. We searched (May 2024) the Medline, PsycINFO, Web of Science, and ProQuest databases to identify clinical trials of mental health apps. The risk of bias was assessed using the Cochrane Risk of Bias tool. Only 55 of 171 identified clinical trials reported AEs. AEs were more likely to be reported in trials sampling schizophrenia and delivering apps with symptom monitoring technology. The meta-analytic deterioration rate from 13 app conditions was 6.7% (95% CI = 4.3, 10.1, I2 = 75%). Deterioration rates did not differ between app and control groups (OR = 0.79, 95% CI = 0.62-1.01, I2 = 0%). Reporting of AEs was heterogeneous, in terms of assessments used, events recorded, and detail provided. Overall, few clinical trials of mental health apps report AEs. Those that do often provide insufficient information to properly judge risks related to app use.

Cognitive behavioural therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia. CBT-I is a multi-component intervention comprising psychoeducation, sleep restriction, stimulus control, cognitive, and relaxation therapy. The relative efficacy of its components has yet to be investigated with state-of-the-art meta-analytic methods. PubMed, MEDLINE, PsycINFO, PsycARTICLES, and CINAHL were searched according to a pre-registered protocol using search terms indicative of insomnia and CBTI. Baseline-to-post-treatment effect sizes (Cohen's d) were calculated in a component network meta-analysis. Eighty studies representing 15,351 participants (mean age 44.9 years, 70.1 % female) were included. For the primary outcome insomnia severity, a significant positive effect for sleep restriction therapy (d = -0.45; 95 % CI: [-0.63; -0.36]) was found. Overall, the results suggest that sleep restriction therapy improves self-reported sleep continuity and sleep quality, and stimulus control therapy improves self-reported and objective total sleep time. No significant effects of psychoeducation, relaxation therapy, and cognitive therapy, and no further significant effects of any CBT-I component on objective sleep parameters were found. The most common sources of bias were a lack of blinding, missing outcome data, and the absence of study protocols. The current results suggest that sleep restriction therapy and stimulus control therapy are the most effective components of CBT-I.

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.

There is growing enthusiasm towards the role of smartphone app-based interventions in the management of insomnia and related sleep problems. A considerable number of apps designed to address insomnia have been developed in recent years, and randomized controlled trials (RCTs) have begun to explore their efficacy. We conducted a meta-analysis investigating the effectiveness of apps for insomnia and sleep disturbances. From 19 RCTs, we identified significant pooled effect sizes for the primary outcomes of self-reported insomnia (g = 0.60; 05 % CI = 0.44, 0.76; NNT = 4.8) and sleep disturbances (g = 0.70; 95 % CI = 0.58, 0.83; NNT = 4.1) in favour of apps over control conditions. These effects remained robust when restricting the analyses to trials that delivered a placebo control, received a lower risk of bias rating, and had a larger sample size. Significant pooled effects in favour of apps were also observed for secondary outcomes of night time awakenings (g = 0.56), total sleep time (g = 0.33), and sleep onset latency (g = 0.32), but non-significant effects emerged for daytime sleepiness, dysfunctional beliefs about sleep, sleep efficiency, sleep hygiene, and wake after sleep onset. The pooled dropout rate from app conditions was 13.1 % (95 % CI = 8.3, 20.0), which was significantly higher than control conditions (OR = 1.78, 95 % CI = 1.39, 2.28). Findings suggest that stand-alone app-based interventions can effectively address insomnia and sleep disturbances, and may play an important role in the management of these symptoms.

Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app-based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design.

We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app.

In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle.

A total of 98 participants were randomized into the Somzz (n=49, 50%) and SHE (n=49, 50%) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t95=3.85; F2,95=22.76; ηp2=0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t68=2.61; F2,68=5.85; ηp2=0.03; P=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen d=-0.62 to -1.35; P<.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t95=-3.32; F2,91=69.87; ηp2=0.41; P=.001), wake after sleep onset (t95=2.55; F2,91=51.81; ηp2=0.36; P=.01), satisfaction (t95=-2.05; F2,91=26.63; ηp2=0.20; P=.04) related to sleep, and mental health outcomes, including depression (t95=2.11; F2,94=29.64; ηp2=0.21; P=.04) and quality of life (t95=-3.13; F2,94=54.20; ηp2=0.33; P=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12% (6/49).

Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance.

Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L.

To evaluate the impact of poor sleep quality on occurrence of post-traumatic stress disorder (PTSD) in trauma patients.

We prospectively recruited 256 trauma patients hospitalized in 4 general hospitals in Zunyi during the period from October, 2021 to November, 2022, and 226 of the participants completed the PTSD survey and assessment. The patients' sleep quality within a month before trauma was estimated using Pittsburgh Sleep Quality Index (PSQI), and their sleep quality within 7 days after admission was monitored by smart bracelet sleep monitoring; the PTSD Checklist-Civilian Version (PCL-C) was used to detect the occurrence of PTSD during the follow-up.

The detection rate of PTSD in the patients was 19.47% at 1 month and 17.61% at 3 months after trauma. The patients who developed PTSD had poorer sleep quality before the trauma, as shown by significantly higher PSQI scale scores (P < 0.001), than those without PTSD, and they showed a sleep abnormality rate as high as 72.73% prior to PTSD onset. Within 7 days after admission, the patients developing PTSD had lower sleep quality scores with more frequent night awakenings (P < 0.05). A 1 month and 3 months after trauma, the patients with PTSD had significantly higher PSQI scores than those without PTSD (P < 0.05).

PTSD is more likely to occur in trauma patients with poor sleep quality before trauma.

Chronic insomnia disorder (simplified in this document as insomnia) is an increasingly common clinical condition in society and a frequent complaint at the offices of different areas of health practice (particularly Medicine and Psychology). This scenario has been accompanied by a significant evolution in treatment, as well as challenges in approaching patients in an appropriately way. This clinical guideline, coordinated by the Brazilian Sleep Association and the Brazilian Association of Sleep Medicine and counting on the active participation of various specialists in the area, encompasses an update on the diagnosis and treatment of insomnia in adults. To this end, it followed a structured methodology. Topics of interest related to diagnosis were written based on theoretical framework, evidence in the literature, and professional experience. As for the topics related to the treatment of insomnia, a series of questions were developed based on the PICO acronym (P - Patient, problem, or population; I - Intervention; C - Comparison, control, or comparator; O - Outcome). The work groups defined the eligible options within each of these parameters. Regarding pharmacological interventions, only the ones currently available in Brazil or possibly becoming available in the upcoming years were considered eligible. Systematic reviews were conducted to help prepare the texts and define the level of evidence for each intervention. The final result is an objective and practical document providing recommendations with the best scientific support available to professionals involved in the management of insomnia.

This systematic review and meta-analysis was conducted to provide an analysis of the published data about the effects of cognitive behavioral therapies on the depression of older adults with a diagnosis of Alzheimer's disease.

This study was performed following the PRISMA 2020 guidelines. The search was performed between March and April 2023, using four electronic databases: PubMed, Web of Science, Cinhal and Scopus. Different keywords combined with Boolean operators were utilized. Only 11 articles were included out of the initial 212.

Cognitive behavioral therapy was found to reduce depression in individuals with Alzheimer's, including treatments with low frequency but a longer intervention time.

This systematic review and meta-analysis found that the psychosocial therapy cognitive behavioral therapy is effective in improving depression in individuals with a diagnosis of Alzheimer's. However, results are inconclusive due to the disparity of the findings and the heterogeneity of the applied protocols, so more studies are needed on this topic.

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=416396, CRD42023416396.