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Abstract Background Digital therapeutics (DTx) is a treatment option that uses computer software to provide evidence-based interventions for medical disorders. DTx platforms are digital services that facilitate interactions among stakeholders of DTx treatment within a standardized structure. However, there is still a lack of overall awareness regarding the effectiveness and usage of DTx and DTx platforms. This study aimed to investigate insomnia patients’ recognition, thoughts, feelings, and demands for conventional treatments versus DTx for insomnia. Methods Nine participants, aged 19–50 years, who had experience with professional medical interventions for insomnia, were recruited through purposive sampling. Two online focus group interviews, each lasting 1.5 h, were conducted. The interview questions focused on difficulties encountered during conventional treatment, inadequate recognition of DTx, and concerns and demands regarding DTx and its platform. The data were analyzed using thematic analysis. Results The participants reported subjective difficulties associated with receiving conventional treatment, including concerns about drug side effects and dependence, social stigma, and lack of perceived necessity for treatment. They expressed concerns about DTx, such as cost-effectiveness, evidence on efficacy, and concerns about breach of personal information. Additionally, their demands included convenience of use, reduction in social stigma related to the use of DTx, compatibility of DTx with other healthcare systems, and enhanced communication with healthcare providers when using DTx platforms. Conclusions The focus group highlighted the need for increased awareness, demonstrated efficacy, cost-effectiveness, cybersecurity measures, and accessibility of insomnia DTx and its platforms. Tailored approaches considering patient characteristics are crucial for widespread adoption of insomnia DTx and its platforms.

Abstract This systematic review and meta-analysis aimed to investigate the prevalence of self-reported sleep disturbances in people living with HIV considering the effects of age, depression, anxiety, CD4 cell counts, time since HIV diagnosis, study region, and the instruments used to measure sleep disturbances. We searched PubMed, PsycINFO, and EMBASE to include eligible articles. In this meta-analysis of 43 studies, the pooled prevalence of self-reported sleep disturbances was 52.29% (95% confidence interval 47.69–56.87). The subgroup analyses revealed that variations in the sleep measurements and study region significantly contributed to the observed heterogeneity. In the meta-regression analyses, higher proportions of participants with depression or anxiety and longer times since HIV diagnosis were significantly associated with a higher prevalence of self-reported sleep disturbances after adjusting for mean age. Our findings emphasise the substantial burden of sleep disturbances in people living with HIV and identified comorbid depression and anxiety and the time since HIV diagnosis as significant moderators. These results underscore the importance of considering these factors when designing tailored screening programmes for high-risk patients and implementing early interventions to prevent and mitigate sleep disturbances in people living with HIV.

Abstract Despite research into the development of digital cognitive behavioral therapy for insomnia (dCBT-I), research into the outcomes of dCBT-I on insomnia and the associated clinical conditions of depression and anxiety have been limited. The PubMed, PsycINFO (Ovid), Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) on adult patients with insomnia also having reported measures of depressive or anxiety symptoms. In total, 2504 articles were identified after duplicate removal, and 22 RCTs were included in the final meta-analysis. At the post-treatment assessment, the dCBT-I group had a small to moderate effect in alleviating depressive (standardized mean difference (SMD) = −0.42; 95% CI: −0.56, −0.28; p

Background: Experiences of negative social interactions and childhood trauma (CT) can lead to aberrant hypothalamic–pituitary–adrenal functions. Poor theory of mind (ToM) ability is related to increased social stress levels; however, studies on the relationship between ToM and cortisol remain scarce. Objective: This study aimed to evaluate the relationship between ToM and the hair cortisol concentration (HCC) in healthy young adults considering the moderating role of CT. Method: A total of 206 healthy young adults were divided into two groups based on an experience of moderate-to-severe childhood trauma (CT+ and CT–). To determine whether CT moderated the relationship between ToM and HCC, moderation analysis was conducted controlling for age, sex, years of education, and scores of perceived stress, depression, and anxiety. Results: CT+ individuals reported higher subjective stress perception and depressive symptoms than CT– individuals, whereas anxiety-related symptoms, ToM, and HCC were not different between the groups. The experience of CT significantly moderated the relationship between ToM and HCC. The association between poorer ToM ability and higher HCC was significant only in CT+ group. Conclusion: CT is a moderator of the association between ToM and HCC, indicating the importance of CT in social cognition and the stress response.

Background: Cognitive behavioral therapy for insomnia (CBTI) is an effective treatment for insomnia treatment, but access is limited. Digital CBT-I (dCBT-I) may help to address this access issue. Numerous studies worldwide have demonstrated the beneficial effects of dCBT-I. However, there is a lack of studies comparing dCBT-I with a control group using the same interface. Aims & Objectives: This study assessed the efficacy and the safety of the smartphone-based dCBT-I app compared with the sham app. Methods: Data were pooled from 2 double-blind, sham-controlled RCT studies. A total of 120 patients with insomnia were randomized to dCBT-I app "WELT-I" (n=60) or a sham app (n=60) group. WELT-I is a multicomponent intervention such as sleep hygiene education, stimulus control, sleep restriction, cognitive restructuring, and relaxation therapy. The Sham app was designed to match WELT-I on installation, log-in, engagement, and delivery of content to ensure double-blindness, except the content had no therapeutic effect. The primary outcome was the change in sleep efficiency from baseline after 6 weeks of intervention. The first trial was a conventional trial with face-to-face onsite visits, and the second trial was a fully decentralized clinical trial (DCT) except for the informed consent, which was obtained onsite. Results: The final analysis included 106 patients. Both the WELT-I and sham app groups exhibited improvements in sleep outcomes. The WELT-I group had a significantly greater improvement in sleep efficiency (SE) from baseline (63.5 %, standard deviation [SD] 14.9) to post-intervention (76.0 %, SD 14.5) than sham app group (from 59.6 % [SD 11.7] to 65.8 % [SD 14.6]; estimated mean difference 7.70 (95% confidence interval [CI] 3.1 to 12.3; partial η2 0.10; p=0.001). Sleep onset latency (SOL) was also significantly reduced in WELT-I group (from 58.64 min [SD 41.0] to 33.5 min [SD 45.3]) compared to sham app group (from 67.5 min [SD 50.7] to 54.1 min [SD 39.3]; estimated mean difference -16.7 (95% CI -31.4 to -2.0; partial η2 0.05; p=0.026). As for the safety assessment, no instances of temporarily halting the application of apps or fatalities occurred due to adverse events in WELT-I group. Discussion & Conclusion: The results of this pooled analysis demonstrate the robust efficacy of dCBT-I app in improving insomnia symptoms. These findings support the possibility of widespread dissemination of dCBT-I. DCT can facilitate participant recruitment, reduce geographical barriers and provide a platform for evaluating the efficacy and safety of digital therapeutics. Future studies of DCT with larger sample sizes in real-world settings are needed to validate its efficacy and evaluate its generalizability. [ABSTRACT FROM AUTHOR]