The Development of Digital Therapies as a New Therapeutic Option to Treat Diseases: Focus on the International Regulatory Framework

[1]  N. Davenport,et al.  A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. , 2022, Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine.

[2]  Roland Müller-Waldeck.  Kalmeda - Tinnitus , 2022, MMW - Fortschritte der Medizin.

[3]  H. Weise,et al.  The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial , 2022, Journal of medical Internet research.

[4]  K. Forkmann,et al.  Introducing zanadio—A Digitalized, Multimodal Program to Treat Obesity , 2022, Nutrients.

[5]  M. Bellgrove,et al.  Digital cognitive training in children with attention-deficit/hyperactivity disorder: a study protocol of a randomised controlled trial , 2022, BMJ Open.

[6]  U. Bonnet,et al.  How Effective is a Web-Based Mental Health Intervention (Deprexis) in the Treatment of Moderate and Major Depressive Disorders when started during Routine Psychiatric Inpatient Treatment as an Adjunct Therapy? A Pragmatic Parallel-Group Randomized Controlled Trial , 2022, Fortschritte der Neurologie · Psychiatrie.

[7]  A. Stark-Inbar,et al.  Nerivio® remote electrical neuromodulation for acute treatment of chronic migraine. , 2021, Pain management.

[8]  Ji Sun Hong,et al.  Introduction of digital therapeutics , 2021, Comput. Methods Programs Biomed..

[9]  H. Richter,et al.  Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. , 2021, Contemporary clinical trials.

[10]  S. Ghaemi,et al.  A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial , 2021, JMIR formative research.

[11]  S. Kiran,et al.  A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia , 2021, Frontiers in Neurology.

[12]  T. D. Hull,et al.  Digital Health and Artificial Intelligence for PTSD: Improving Treatment Delivery Through Personalization , 2021, Psychiatric Annals.

[13]  Nisarg A. Patel,et al.  Characteristics and challenges of the clinical pipeline of digital therapeutics , 2020, npj Digital Medicine.

[14]  C. Morin.  Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy , 2020, Expert review of medical devices.

[15]  Christopher B. Miller,et al.  Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial , 2020, Depression and anxiety.

[16]  A. Mannarino,et al.  Evaluating the Impact of Freespira on Panic Disorder Patients’ Health Outcomes and Healthcare Costs within the Allegheny Health Network , 2020, Applied psychophysiology and biofeedback.

[17]  B. Meskó,et al.  The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database , 2020, npj Digital Medicine.

[18]  E. V. van Someren,et al.  Combined Internet-Based Cognitive-Behavioral and Chronobiological Intervention for Insomnia: A Randomized Controlled Trial , 2019, Psychotherapy and Psychosomatics.

[19]  Simon Makin,et al.  The emerging world of digital therapeutics , 2019, Nature.

[20]  Sean Khozin,et al.  Decentralized Trials in the Age of Real‐World Evidence and Inclusivity in Clinical Investigations , 2019, Clinical pharmacology and therapeutics.

[21]  J. Chung.  Digital therapeutics and clinical pharmacology , 2019, Translational and clinical pharmacology.

[22]  S. Kyle,et al.  Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial , 2019, JAMA psychiatry.

[23]  H. Chhabra,et al.  Smartphone app in self-management of chronic low back pain: a randomized controlled trial , 2018, European Spine Journal.

[24]  Gavin Giovannoni,et al.  e-Health and multiple sclerosis: An update , 2018, Multiple sclerosis.

[25]  Mathew E. Hirschtritt,et al.  Digital Technologies in Psychiatry: Present and Future. , 2018, Focus.

[26]  J. Jaccard,et al.  Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. , 2018, Gastroenterology.

[27]  T. Thornton-Wells,et al.  Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development , 2018, Clinical pharmacology and therapeutics.

[28]  G. Andrews,et al.  Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. , 2018, Journal of anxiety disorders.

[29]  T. Friede,et al.  Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis , 2018, Journal of Neurology, Neurosurgery, and Psychiatry.

[30]  C. Beevers,et al.  Effectiveness of an Internet Intervention (Deprexis) for Depression in a United States Adult Sample: A Parallel-Group Pragmatic Randomized Controlled Trial , 2017, Journal of consulting and clinical psychology.

[31]  Gerhard Andersson,et al.  Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data , 2017, JAMA psychiatry.

[32]  Rajan Merchant,et al.  Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial. , 2016, The journal of allergy and clinical immunology. In practice.

[33]  L. Marsch,et al.  A Comparative Study of the Therapeutic Education System for Incarcerated Substance-Abusing Offenders , 2016 .

[34]  B. Meyer,et al.  Vorvida: study protocol of a randomized controlled trial testing the effectiveness of Internet-based self-help program for the reduction of alcohol consumption for adults , 2016, BMC Psychiatry.

[35]  Raimar Kern,et al.  Designing an Electronic Patient Management System for Multiple Sclerosis: Building a Next Generation Multiple Sclerosis Documentation System , 2016, Interactive journal of medical research.

[36]  S. Landau,et al.  Assessing Cognitive behavioural Therapy in Irritable Bowel (ACTIB): protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults , 2015, BMJ Open.

[37]  W. Bickel,et al.  Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. , 2014, Journal of consulting and clinical psychology.

[38]  Daniel Polsky,et al.  Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. , 2014, The American journal of psychiatry.

[39]  J. Carroll,et al.  A New Dimension of Health Care: Systematic Review of the Uses, Benefits, and Limitations of Social Media for Health Communication , 2013, Journal of medical Internet research.

[40]  S. Kyle,et al.  A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. , 2012, Sleep.

[41]  C. Quinn,et al.  Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control , 2011, Diabetes Care.

[42]  Yi Tsong,et al.  Some fundamental issues with non‐inferiority testing in active controlled trials , 2002, Statistics in medicine.

[43]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[44]  R. Julien,et al.  A Primer of Drug Action: A Concise, Nontechnical Guide to the Actions, Uses, and Side Effects of Psychoactive Drugs , 1997 .