Dissemination of digital cognitive behavioural therapy is a promising approach for treating insomnia in the broad population. Current evidence supports the effectiveness of the digital format, but clinical findings are often limited by the choice of control group and lack of in-depth therapeutic measures. This study was designed to investigate the specific effects of digital cognitive behavioural therapy in comparison to a self-monitoring application. Participants meeting criteria for insomnia were randomly allocated (1:1) to 8 weeks of digital cognitive behavioural therapy or 8 weeks of digital sleep monitoring (control application). The primary outcome, insomnia severity, was assessed at baseline, 8- and 16-weeks post-randomisation. Secondary outcomes included the assessment of sleep via application-integrated sleep diaries and actigraphy. Linear-mixed models were fitted to assess between-group differences. Fifty-six participants (48 females, mean age: M = 45.55 ± 13.70 years) were randomised to either digital cognitive behavioural therapy (n = 29) or digital sleep monitoring (n = 27). At 8- and 16-weeks post-randomisation, large treatment effects (d = 0.87-1.08) indicated robust reductions (-3.70 and -2.97, respectively; p ≤ 0.003) in insomnia severity in the digital cognitive behavioural therapy arm, relative to digital sleep monitoring. Treatment effects in favour of digital cognitive behavioural therapy were also found for self-reported and actigraphy-derived sleep continuity variables, indicating that sleep improved throughout the 8-week intervention period. Our study reinforces the role of digital cognitive behavioural therapy in achieving clinical improvements for patients with insomnia, affirming previous findings and supporting the specific effects of cognitive behavioural therapy.

UNASSIGNED: Diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) is based on clinical evaluation of symptoms by a psychiatrist, referencing results of psychological tests. When diagnosing ADHD, the child\'s behavior and functionality in real-life situations are critical components. However, direct observation by a clinician is often not feasible in practice. Therefore, such information is typically gathered from primary caregivers or teachers, which can introduce subjective elements. To overcome these limitations, we developed AttnKare-D, an innovative digital diagnostic tool that could analyze children\'s behavioral data in Virtual Reality using Artificial Intelligence. The purpose of this study was to explore the utility and safety of AttnKare-D for clinical application.
UNASSIGNED: A total of 21 children aged between 6 and 12 years were recruited for this study. Among them, 15 were children diagnosed with ADHD, 5 were part of a normal control group, and 1 child was excluded due to withdrawal of consent. Psychological assessments, including K-WISC, Conners CPT, K-ARS, and K-CBCL, were conducted for participants and their primary caregivers. Diagnoses of ADHD were confirmed by child and adolescent psychiatrists based on comprehensive face-to-face evaluations and results of psychological assessments. Participants underwent VR diagnostic assessment by performing various cognitive and behavioral tasks in a VR environment. Collected data were analyzed using an AI model to assess ADHD diagnosis and the severity of symptoms.
UNASSIGNED: AttnKare-D demonstrated diagnostic performance with an AUC of 0.893 when compared to diagnoses made by child and adolescent psychiatrist, showing a sensitivity of 0.8 and a specificity of 1.0 at a cut-off score of 18.44. AttnKare-D scores showed a high correlation with K-ARS scores rated by parents and experts, although the correlation was relatively low for inattention scores.
UNASSIGNED: Results of this study suggest that AttnKare-D can be a useful tool for diagnosing ADHD in children. This approach has potential to overcome limitations of current diagnostic methods, enhancing the accuracy and objectivity of ADHD diagnoses. This study lays the groundwork for further improvement and research on diagnostic tools integrating VR and AI technologies. For future clinical applications, it is necessary to conduct clinical trials involving a sufficient number of participants to ensure reliable use.

BACKGROUND: The use of virtual reality (VR)-based biofeedback (BF), a relatively new intervention, is a non-pharmacological treatment of depressive and anxiety symptoms. However, studies on VR-based BF are lacking and inconclusive.
METHODS: A total of 131 adults were recruited from the community. Participants who scored ≥10 on the Patient Health Questionnaire-9 (PHQ-9) or ≥9 on the Panic Disorder Severity Scale (PDSS) were included in the group with depressive or anxiety symptoms (DAS group), and others as the healthy control group (HC group). Participants from the DAS group were randomly assigned to VR-based or conventional BF intervention. All individuals visited at three times (weeks 0, 2, and 4), and completed the Montgomery-Asberg Depression Rating Scale (MADRS), the State-Trait Anxiety Inventory (STAI), and a visual analog scale (VAS) before and after the intervention, and PHQ-9 at the beginning and final visit.
RESULTS: The analysis included a total of 118 participants (DAS/VR: 40, DAS/BF: 38, HC/VR: 40). There was no significant difference in demographic variables among the three groups. After the intervention, the DAS/VR group exhibited significant decreases in MADRS (70.0 %), PHQ-9 (64.1 %), STAI (29.5 %), and VAS (61.7 %) scores compared to the baseline (p <0.001). There were no significant differences between the effects of VR-based BF and conventional BF with a therapist. The HC group also showed significant decreases in the measures of depression and anxiety after receiving VR-based BF.
CONCLUSIONS: VR-based BF was effective in reducing depressive and anxiety symptoms, even for subthreshold depression and anxiety symptoms in the HC group.

UNASSIGNED: Exergaming has the potential to increase adherence to exercise through play, individually tailored training, and (online) remote monitoring. Reality Digital Therapeutics (Reality DTx®) is a digital therapeutic software platform for augmented reality (AR) glasses that enables a home-based gait-and-balance exergaming intervention specifically designed for people with Parkinson\'s disease (pwPD).
UNASSIGNED: The primary objective was to evaluate the feasibility and potential efficacy of Reality DTx® AR exergaming intervention for improving gait, balance, and walking-adaptability fall-risk indicators. The secondary objective was to evaluate the potential superiority of AR glasses [Magic Leap 2 (ML2) vs. HoloLens 2 (HL2)].
UNASSIGNED: This waitlist-controlled clinical feasibility study comprised three laboratory visits (baseline; pre-intervention; and post-intervention), a home visit, and a 6-week AR exergaming intervention. Five complementary gait-and-balance exergames were remotely prescribed (default five sessions/week of 30 active minutes/session), monitored, and tailored. Feasibility was assessed in terms of safety, adherence, and user experience. During laboratory visits, gait-and-balance capacity was assessed using standard clinical gait-and-balance tests and advanced walking-adaptability fall-risk assessments.
UNASSIGNED: In total, 24 pwPD participated. No falls and four near falls were reported. Session adherence was 104%. The User Experience Questionnaire scores for Reality DTx® ranged from above average to excellent, with superior scores for HL2 over ML2 for Perspicuity and Dependability. Intervention effects were observed for the Timed Up and Go test (albeit small), the Five Times Sit to Stand test, and walking speed. Walking-adaptability fall-risk indicators all improved post-intervention.
UNASSIGNED: Reality DTx® is a safe, adherable, usable, well-accepted, and potentially effective intervention in pwPD. These promising results warrant future randomized controlled trials on the (cost-)effectiveness of home-based AR exergaming interventions for improving gait, balance, and fall risk.
UNASSIGNED: ClinicalTrials.gov, identifier NCT05605249.

OBJECTIVE: While international guidelines advocate for a multifaceted approach to treating erectile dysfunction (ED) involving physical activities, psychological support, and education, structured programs are infrequent. To address this gap, an app-based therapy was developed, offering a systematic approach. This randomized, single-blind controlled trial aimed to assess the effectiveness of an app-based therapeutic in improving ED.
METHODS: A total of 241 patients (49.74, standard deviation 12.73 yr) with ED (International Index of Erectile Function [IIEF]-5 <22) were randomized to the 12-wk app-based therapy (treatment group [TG], n = 122) or a waiting list for the app with continuation of their current management protocol (control group [CG], n = 119). Patients on long-term medication for ED were included, but subsequent exclusion occurred for those starting new medication. Coprimary endpoints were improvements from baseline to 12 wk in erectile function (IIEF-5), disease-related quality of life (QOL-Med-15), and patient activation (Patient Activation Measure [PAM-13]).
UNASSIGNED: Erectile function (IIEF-5) improved by 4.5 points in the TG versus 0.2 points in the CG (p < 0.0001, 95% confidence interval [CI] 3.4-5.0) group. Quality of life (QOL-Med) improved by 20.5 points in the TG versus -0.0 points in the CG (p < 0.0001, 95% CI 19.2-26.0) group. Patient activation (PAM-13) improved by 11.2 points in the TG versus 0.6 points in the CG (p < 0.0001, 95% CI 9.1-13.6) group. Phosphodiesterase type 5 inhibitor intake had no influence on all observed treatment effects.
CONCLUSIONS: App-based therapy of patients with ED provided a significant, clinically meaningful improvement. Quality of life and patient activation were also enhanced significantly. This program has the potential to change clinical practice in the treatment of ED.
RESULTS: A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.

Digital weight loss interventions present a viable and cost-effective alternative to traditional therapy. However, further evidence is needed to establish the equal effectiveness of both approaches. This randomized controlled non-inferiority trial aimed to compare the effects of an intensive in-person weight loss intervention program with Vitadio digital therapy. One hundred patients with obesity and diagnosed with type 2 diabetes, prediabetes, or insulin resistance were enrolled and randomly assigned to one of the two treatment groups. Over a 6-month period, the control group received five in-person consultations with a physician who specialized in obesity treatment, a dietitian and/or a nutrition nurse, while the intervention group followed the digital program based on a multimodal therapeutic approach. The extent of weight loss was assessed and compared between the groups. Additionally, changes in body composition and metabolic parameters for the digital intervention group were analyzed. The study results demonstrated comparable effectiveness of both treatments for weight reduction. The positive effects of Vitadio were further evidenced by favorable changes in body composition and lipid metabolism and improved glycemic control in the intervention group. These findings suggest that Vitadio is an effective tool for assisting patients with managing obesity and preventing diabetes progression.

BACKGROUND: Visual field defects (VFDs) represent a debilitating poststroke complication, characterized by unseen parts of the visual field. Visual perceptual learning (VPL), involving repetitive visual training in blind visual fields, may effectively restore visual field sensitivity in cortical blindness. This current multicenter, double-blind, randomized, controlled clinical trial investigated the efficacy and safety of VPL-based digital therapeutics (Nunap Vision [NV]) for treating poststroke VFDs.
METHODS: Stroke outpatients with VFDs (>6 months after stroke onset) were randomized into NV (defective field training) or Nunap Vision-Control (NV-C, central field training) groups. Both interventions provided visual perceptual training, consisting of orientation, rotation, and depth discrimination, through a virtual reality head-mounted display device 5 days a week for 12 weeks. The two groups received VFD assessments using Humphrey visual field (HVF) tests at baseline and 12-week follow-up. The final analysis included those completed the study (NV, n = 40; NV-C, n = 35). Efficacy measures included improved visual area (sensitivity ≥6 dB) and changes in the HVF scores during the 12-week period.
RESULTS: With a high compliance rate, NV and NV-C training improved the visual areas in the defective hemifield (>72 degrees2) and the whole field (>108 degrees2), which are clinically meaningful improvements despite no significant between-group differences. According to within-group analyses, mean total deviation scores in the defective hemifield improved after NV training (p = .03) but not after NV-C training (p = .12).
CONCLUSIONS: The current trial suggests that VPL-based digital therapeutics may induce clinically meaningful visual improvements in patients with poststroke VFDs. Yet, between-group differences in therapeutic efficacy were not found as NV-C training exhibited unexpected improvement comparable to NV training, possibly due to learning transfer effects.

BACKGROUND: Concussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child\'s quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms.
OBJECTIVE: The primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group.
METHODS: This study is a double-blind Health Canada-regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion.
RESULTS: The recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted.
CONCLUSIONS: This trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications.
BACKGROUND: ClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802.
UNASSIGNED: DERR1-10.2196/57226.

Despite the promising benefits of self-guided digital interventions for adolescents recovering from concussion, attrition rates for such interventions are high. Evidence suggests that adults can develop therapeutic alliance with self-guided digital interventions, which is in turn associated with intervention engagement. However, no research has examined whether adolescents develop therapeutic alliance with self-guided digital interventions and what factors are important to its development. Additionally, social presence-the extent to which digital encounters feel like they are occurring in person-may be another relevant factor to understanding the nature of the connection between adolescents and a self-guided digital intervention, though this has yet to be explored.
This qualitative study explored the extent to which adolescents recovering from concussion developed therapeutic alliance and social presence during their use of a self-guided digital mindfulness-based intervention. Additionally, this study aimed to determine factors important to adolescents\' development of therapeutic alliance and social presence with the intervention.
Adolescents aged between 12 and 17.99 years who sustained a concussion were recruited from 2 sites: a pediatric emergency department up to 48 hours after a concussion and a tertiary care clinic over 1 month following a concussion to capture adolescents who had both acute and persisting symptoms after concussion. Participants (N=10) completed a 4-week mindfulness-based intervention delivered through a smartphone app. Within the app, participants listened to audio recordings of mindfulness guides (voice actors) narrating psychoeducation and mindfulness practices. At 4 weeks, participants completed questionnaires and a semistructured interview exploring their experience of therapeutic alliance and social presence with the mindfulness guides in the intervention.
Themes identified within the qualitative results revealed that participants developed therapeutic alliance and social presence by \"developing a genuine connection\" with their mindfulness guides and \"sensing real people.\" Particularly important to the development of therapeutic alliance and social presence were the mindfulness guides\' \"personal backgrounds and voices,\" such that participants felt more connected to the guides by knowing information about them and through the guides\' calm tone of voice in audio recordings. Quantitative findings supported qualitative results; participants\' average score for therapeutic alliance was far above the scale midpoint, while the mixed results for social presence measures aligned with qualitative findings that participants felt that the mindfulness guides seemed real but not quite as real as an in-person connection would.
Our data suggest that adolescents can develop therapeutic alliance and social presence when using digital interventions with no direct human contact. Adolescents\' development of therapeutic alliance and social presence with self-guided digital interventions can be bolstered by increasing human-like qualities (eg, real voices) within interventions. Maximizing therapeutic alliance and social presence may be a promising way to reduce attrition in self-guided digital interventions while providing accessible treatment.

BACKGROUND: Increasing physical activity improves glycemic control in patients with type 2 diabetes (T2D). Mobile health (mHealth) interventions have been proven to increase exercise, but engagement often fades with time. As the use of health behavior theory in mHealth design can increase effectiveness, we developed StepAdd, an mHealth intervention based on the constructs of social cognitive theory (SCT). StepAdd improves exercise behavior self-efficacy and self-regulation through the use of goal-setting, barrier-identifying, and barrier-coping strategies, as well as automatic feedback functions. A single-arm pilot study of StepAdd among 33 patients with T2D showed a large increase in step count (mean change of 4714, SD 3638 daily steps or +86.7%), along with strong improvements in BMI (mean change of -0.3 kg/m2) and hemoglobin A1c level (mean change of -0.79 percentage points).
OBJECTIVE: In this study, we aim to investigate the efficacy and safety of StepAdd, an mHealth exercise support system for patients with T2D, via a large, long, and controlled follow-up to the pilot study.
METHODS: This is a randomized, open-label, multicenter study targeting 160 patients with T2D from 5 institutions in Japan with a 24-week intervention. The intervention group will record daily step counts, body weight, and blood pressure using the SCT-based mobile app, StepAdd, and receive feedback about these measurements. In addition, they will set weekly step count goals, identify personal barriers to walking, and define strategies to overcome these barriers. The control group will record daily step counts, body weight, and blood pressure using a non-SCT-based placebo app. Both groups will receive monthly consultations with a physician who will advise patients regarding lifestyle modifications and use of the app. The 24-week intervention period will be followed by a 12-week observational period to investigate the sustainability of the intervention\'s effects. The primary outcome is between-group difference in the change in hemoglobin A1c values at 24 weeks. The secondary outcomes include other health measures, measurements of steps, measurements of other behavior changes, and assessments of app use. The trial began in January 2023 and is intended to be completed in December 2025.
RESULTS: As of September 5, 2023, we had recruited 44 patients. We expect the trial to be completed by October 8, 2025, with the follow-up observation period being completed by December 31, 2025.
CONCLUSIONS: This trial will provide important evidence about the efficacy of an SCT-based mHealth intervention in improving physical activities and glycemic control in patients with T2D. If this study proves the intervention to be effective and safe, it could be a key step toward the integration of mHealth as part of the standard treatment received by patients with T2D in Japan.
BACKGROUND: Japan Registry of Clinical Trials (JRCT) jRCT2032220603; https://rctportal.niph.go.jp/en/detail?trial_id=jRCT2032220603.
UNASSIGNED: DERR1-10.2196/53514.