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Cognitive behavioral therapy for insomnia (CBT-I) has proven to be an effective treatment; however, its accessibility is limited. To address this issue, digital therapeutics for insomnia (DTx-Is), which are software-driven interventions designed to treat insomnia based on CBT-I, have emerged as a potential solution to enhance access. This study aimed to verify the efficacy and safety of WELT-I, a DTx-I. Due to the impact of the global pandemic during the study period, we thought that a decentralized clinical trial (DCT) design that does not require visits to institutions would be appropriate for a clinical study of a digital therapeutic for patients with insomnia. Thus, we also examined the potential of the DCT design as an effective method for validating DTx-Is. A double-blind, sham-controlled randomized DCT was conducted with participants who met the diagnostic criteria for insomnia. Participants were recruited through advertisements posted on an open-access website. WELT-I is a DTx-I based on CBT-I. A sham app was engineered to mirror WELT-I's installation, login, user engagement, and content delivery processes while maintaining double-blind protocols. After randomization, participants were asked to use WELT-I or the sham app for 6 weeks. All treatment processes were fully automated. Sleep parameters were measured through an app-based sleep diary. Self-report questionnaires on sleep, depression, and anxiety were administered via the app at baseline and the end of the study. The primary outcome was sleep efficiency. To investigate the feasibility of the DCT design, compliance, retention rate, participant satisfaction, and time to reach the recruitment goal were evaluated. A total of 89 participants provided consent and underwent screening, and 68 participants were randomly assigned to the WELT-I group (n=33) or control group (n=35). Among them, 14 participants discontinued the trial, leaving 54 participants who completed the study and were included in the final analysis (28 in the WELT-I group and 26 in the control group). WELT-I significantly improved sleep efficiency (least-squares difference=8.28; P=.04) and dysfunctional beliefs about sleep (least-squares difference=-1.03; P=.008) compared with the sham app. The study completed recruitment in 73 days, and the compliance rate was 95% (186/196) in the WELT-I group and 91% (165/182) in the control group. Moreover, the retention rate was 82% (23/28), and the average satisfaction score was 7.2 out of 10. WELT-I showed significant therapeutic efficacy and safety in improving sleep efficiency and sleep-related dysfunctional attitudes in cases of insomnia. In addition, this study demonstrated the feasibility of DCTs, and the findings of rapid recruitment, high compliance and retention rates, and strong participant satisfaction suggest that DCTs have sufficient potential to be expanded to clinical studies verifying the efficacy of other DTx-Is in the future.

Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy. The number of clinical trials for DTx has increased recently, and one of the main targets for DTx is psychiatric disorders. Generalized anxiety disorder (GAD) is one of the most common and notable psychiatric disorders, and it's known that the magnitude of placebo effect in the pharmacotherapy is quite large. The randomized controlled trials (RCTs) with digital placebos are the most reliable clinical trials to evaluate the safety and efficacy of DTx. However, the magnitude of the digital placebo effect and its moderators on GAD have not been investigated, although they are critical to assess the true treatment effect of DTx. The objectives of this study were to identify RCTs with digital placebos as comparators that evaluated GAD assessment scores, to review the characteristics of the RCTs and of the digital placebos in the systematic review, and to investigate the magnitude and its moderators in the meta-analysis. The RCTs evaluating the GAD assessment scores by setting digital placebos as comparators were identified by searching the database of PubMed, Web of Science, and Scopus in July 2024. The characteristics of the RCTs and of the digital placebos were reviewed systematically. The meta-analysis, including subgroup analyses and meta-regressions, was conducted to investigate the magnitude and its moderators of the digital placebos. A total of 54 RCTs were included in the systematic review and 32 RCTs with 3 GAD assessment scores were included in the meta-analysis with a total of 5311 participants. The magnitude of digital placebos for all the included studies was small to moderate (Hedges g=0.28, 95% CI 0.18-0.38). The subgroup analyses showed the significant difference in the magnitude among target population (P=.03), placebo approach (P=.02), and baseline values (P=.02). The meta-regressions also indicated that the primary psychiatric patients in the target population (P=.01), \"Removed\" type in placebo approach (P=.04) and high baseline values (P =.02) were moderators for the magnitude of digital placebos. This study showed the small-to-moderate and statistically significant digital placebo effect on GAD assessment scores. Target population, placebo approach, and baseline values were also identified as the moderators of the placebo effect. It would be effective to create the study protocols for the DTx trials with digital placebos by considering the moderators identified in this study.

Digital therapeutics are emerging as a new form of therapeutic interventions. Unlike conventional therapeutics, digital therapeutics deliver interventions directly to patients using an evidence‐based, clinically evaluated software to treat, manage, or prevent diseases. Digital therapeutics manifest in diverse forms such as web‐based applications, mobile applications on smart devices, virtual reality, and video games. As its own product category for FDA approval, digital therapeutics can function as stand‐alone treatments or in combination with conventional therapeutics to improve adherence and/or efficacy. Here, we review the clinical landscape of digital therapeutics. We summarize FDA‐approved products and their clinical use, overview >300 ongoing clinical trials, and discuss challenges for their clinical translation and strategies to overcome the same.

Technological progress in digital therapeutics—and, in particular prescription digital therapeutics (PDTs)—has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.

Recent advancements in cognitive neuroscience and digital technology have significantly accelerated the adoption of digital therapeutics for cognitive impairment. This viewpoint explores the innovative applications of digital therapeutics in the assessment, intervention, management, and monitoring of cognitive disorders while highlighting key challenges that impede their widespread integration into clinical practice. Drawing on the definition of cognitive digital therapeutics (CDTx) and the multistakeholder collaboration required for its development and implementation, this paper examines the role of digital technologies in cognitive health and explores challenges from multiple perspectives, including clinical practice, policy framework, user adoption, ethics and privacy, and data interoperability and system integration. In addition, this viewpoint offers strategic recommendations to address the challenges and future prospects of CDTx, emphasizing the importance of multistakeholder collaboration, prioritizing user-centered design, and leveraging emerging technologies such as artificial intelligence to enhance the scalability, sustainability, and future integration of CDTx.

A 12-week digital health program for nonalcoholic fatty liver disease (NAFLD) previously showed feasibility in engagement, program retention, and clinical outcomes. This study investigates whether improvements in cardiometabolic risk factors achieved during a 12-week active program were sustained over a subsequent 6-month follow-up period. The primary objective of this analysis was to evaluate whether the clinical improvements achieved after a 12-week program were maintained over the subsequent 6-month period, which did not include coaching or new intervention materials. In addition, the study aimed to assess participants' retention and engagement with the maintenance program. In a 9-month, single-arm study using the Sidekick app (Sidekick Health), individuals with NAFLD and BMI >30 or metabolic syndrome or type 2 diabetes were included. The initial 12 weeks focused on providing education about diet, physical activity, stress management, and sleep, followed by 6 months without coaching or new intervention materials. The measured outcomes encompassed demographics, body composition, liver fat assessed using magnetic resonance imaging-proton density fat fraction (MRI-PDFF), and blood markers. Of the 34 participants who completed the first 12 weeks, 28 (82%) completed the 9-month study measurements. The median age was 63.0 years (IQR 53.5-71.0) and 57.1% (16/28) were women. At 9 months, compared to baseline, the mean weight loss was 4.0 kg (SD 5.0; P<.001). Liver fat decreased by 2.5% (SD 4.5; P<.001), with an 18.4% relative reduction. Systolic blood pressure decreased by 8.3 mm Hg (SD 13.4, P<.001) and diastolic by 2.5 mm Hg (SD 6.0; P=.02). Waist circumference decreased by 4.7 cm (SD 7.1; P<.001) and median glycated hemoglobin A1c (HbA1c) decreased by 19.5 mmol/mol (P<.001). Sustained improvements in liver fat and metabolic markers suggest that Sidekick Health's digital program is a promising strategy for managing NAFLD without requiring continuous coaching.

While the number of digital therapeutics (DTx) has proliferated, there is little real-world research on the characteristics of providers recommending DTx, their recommendation behaviors, or the characteristics of patients receiving recommendations in the clinical setting. The aim of this study was to characterize the clinical and demographic characteristics of patients receiving DTx recommendations and describe provider characteristics and behaviors regarding DTx. This retrospective cohort study used electronic health record data from a large, integrated health care delivery system. Demographic and clinical characteristics of adult patients recommended versus not recommended DTx by a mental health provider between May 2020 and December 2021 were examined. A cross-sectional survey of mental health providers providing these recommendations was conducted in December 2022 to assess the characteristics of providers and recommendation behaviors related to DTx. Parametric and nonparametric tests were used to examine statistical significance between groups. Of 335,250 patients with a mental health appointment, 53,546 (16%) received a DTx recommendation. Patients recommended to DTx were younger, were of Asian or Hispanic race or ethnicity, were female, were without medical comorbidities, and had commercial insurance compared to those without a DTx recommendation (P<.001). More patients receiving a DTx recommendation had anxiety or adjustment disorder diagnoses, but less had depression, bipolar, or psychotic disorder diagnoses (P<.001) versus matched controls not recommended to DTx. Overall, depression and anxiety symptom scores were lower in patients recommended to DTx compared to matched controls not receiving a recommendation, although female patients had a higher proportion of severe depression and anxiety scores compared to male patients. Provider survey results indicated a higher proportion of nonprescribers recommended DTx to patients compared to prescribers (P=.008). Of all providers, 29.4% (45/153) reported using the suggested internal electronic health record-based tools (eg, smart text) to recommend DTx, and of providers recommending DTx resources to patients, 64.1% (98/153) reported they follow up with patients to inquire on DTx benefits. Only 38.4% (58/151) of respondents report recommending specific DTx modules, and of those, 58.6% (34/58) report following up on the impact of these specific modules. DTx use in mental health was modest and varied by patient and provider characteristics. Providers do not appear to actively engage with these tools and integrate them into treatment plans. Providers, while expressing interest in potential benefits from DTx, may view DTx as a passive strategy to augment traditional treatment for select patients.

Medications for the treatment of opioid use disorder, such as buprenorphine, are effective and essential for addressing the opioid epidemic. However, high dropout rates from medication remain a challenge. Behavioral treatment with contingency management and cognitive behavioral counseling has shown promise for improving the outcomes of buprenorphine treatment but is complicated to deliver. The delivery of behavioral treatment through technology-based platforms has the potential to make it more feasible for widespread dissemination. reSET-O is a prescription digital therapeutic and a commercial adaptation of the Therapeutic Education System, an internet-based program with a Community Reinforcement Approach to cognitive behavioral therapy. It delivers cognitive behavioral therapy modules and contingency management rewards upon completion of modules and negative urine drug screens. This pilot study aims to assess the feasibility and acceptability of reSET-O in a community-based opioid treatment program with a Hub and Spoke model of care as part of a larger strategy to maintain individuals in treatment. Objective and qualitative results, as well as acceptability and likeability of reSET-O, were obtained from 15 individuals. English-speaking individuals aged ≥18 years with a diagnosis of current opioid use disorder were recruited after being on buprenorphine for at least 1 week of treatment. Two 12-week prescriptions for reSET-O were written for the 24-week study. Patient reports of drug use and likeability scales of reSET-O were conducted at weeks 4, 8, 12, and 24 of the study. Qualitative interviews were also conducted. A total of 4 providers were recruited and provided feedback on the acceptability and feasibility of reSET-O. Of the 15 participants who participated in this pilot study, 7 (47%) completed 24 weeks, and 8 (53%) were unable to complete because of dropout after enrollment, attrition in treatment, or incarceration. An average of US $96 in contingency management rewards were earned by participants for the completion of modules for the duration of the pilot study. Participants' subjective feedback revealed that reSET-O was easy to use, enjoyable, and helped provide a safe space to admit recurring substance use. reSET-O was well accepted based on patient and provider feedback in this pilot study; however, adherence and retention in treatment remain areas for improvement. Randomized control trials are needed to assess whether retention of community-based buprenorphine treatment is enhanced through the use of technology-based behavioral interventions such as reSET-O.

Background Digital therapeutics (DTx) are software or other tools that support or implement medical practices such as disease prevention, diagnosis, and treatment using digital technology. DTx has been approved in Japan, and it is anticipated that the number of approvals will increase in the future. DTx differs from conventional medical devices in that its primary purpose is treatment. Aim This study aims to identify the key drivers of DTx in Japan by analyzing patents in the field of medical information, including DTx. Methodology This study visualizes the results of patent analyses for DTx and examines patent applications that feature applied technology and indications in the medical information field as the key drivers. The study will also employ patent citation analysis. It can be argued that the more citations a patent receives, the more similar research and development activities are being conducted, and the greater the competition. The number of citations per patent application will also be calculated to help identify areas where the value per patent application is high and competition intensifies. A patent citation matrix analysis will be conducted for notable Japanese companies in the DTx field. The citation matrix analysis consists of the number of citations and the company's selfcitation ratio to visualize the patent value. This study investigates the key drivers of DTx by analyzing patent technologies, focusing on patent applications with a high number of citations or a high selfcitation ratio. Results Key drivers of digital therapeutics were examined by analyzing patents in the fields of healthcare informatics and diagnostics. In terms of the number of patent applications and citations in Japan, numerous patents were related to “applications,” “sensors,” “medical imaging,” “central nervous system/psychiatry,” and “heart.” As a result, Japanese companies are expected to conduct R&D with an eye toward overseas expansion.

Home-based (unsupervised) buprenorphine initiation is considered safe and effective, yet many patients report barriers to successful treatment initiation. Prescription digital therapeutics (PDTs) are software-based disease treatments regulated by the US Food and Drug Administration (FDA). The reSET-O PDT was authorized by the FDA in 2018 and delivers behavioral treatment for individuals receiving buprenorphine for opioid use disorder (OUD). A prototype PDT (PEAR-002b) designed for use with reSET-O was developed to assist in unsupervised buprenorphine initiation. The primary objective of this pilot study is to evaluate the acceptability of PEAR-002b in individuals with OUD who use it to support buprenorphine initiation, their unsupervised buprenorphine initiation success rate, and their medication adherence. Ten adults with OUD will be recruited for acceptability and feasibility testing. Outcomes will be assessed using week-1 visit attendance, participant interviews and satisfaction surveys, and urine drug screening (UDS). Three tools will be used in the study: PEAR-002b, reSET-O, and EmbracePlus. PEAR-002b includes a new set of features designed for use with reSET-O. The mechanism of action for the combined PEAR-002b and reSET-O treatment is a program of medication dosing support during week 1 of the initiation phase, cognitive behavioral therapy, and contingency management. During the medication initiation phase, participants are guided through a process to support proper medication use. PEAR-002b advises them when to take their buprenorphine based on provider inputs (eg, starting dose), self-reported substance use, and self-reported withdrawal symptoms. This study also administers the EmbracePlus device, a medical-grade smartwatch, to pilot methods for collecting physiologic data (eg, heart rate and skin conductance) and evaluate the device's potential for use along with PDTs that are designed to improve OUD treatment initiation. Home buprenorphine initiation success will be summarized as the proportion of participants attending the post-buprenorphine initiation visit (week 1) and the proportion of participants who experience buprenorphine initiation-related adverse events (eg, precipitated withdrawal). Acceptability of PEAR-002b will be evaluated based on individual participants' ratings of ease of use, satisfaction, perceived helpfulness, and likelihood of recommending PEAR-002b. Medication adherence will be evaluated by participant self-report data and confirmed by UDS. UDS data will be summarized as the mean of individual participants' proportion of total urine samples testing positive for buprenorphine or norbuprenorphine over the 4-week study. This project was funded in September 2019. As of September 2022, participant enrollment is ongoing. This is the first study to our knowledge to develop a PDT that assists with unsupervised buprenorphine initiation with the intent to better support patients and prescribers during this early phase of treatment. This pilot study will assess the acceptability and utility of a digital therapeutic to assist individuals with OUD with unsupervised buprenorphine initiation. ClinicalTrials.gov NCT05412966; https://clinicaltrials.gov/ct2/show/NCT05412966. PRR1-10.2196/43122.