신경정신과 질환에 대한 디지털 치료기기의 무작위대조군연구 등록 현황 분석: WHO-ICTRP를 중심으로
Current Status and Characteristics of Registered Randomized Controlled Trials of Digital Therapeutics for Neuropsychiatric Disorders Based on the WHO-ICTRP
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Objectives: To analyze the current status and characteristics of registered randomized controlled trials (RCTs) of digital therapeutics (DTx) for neuropsychiatric disorders using the World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP). Methods: We searched the WHO-ICTRP database using the terms ‘digital therapeutics’ and ‘digital therapeutic’ up to October 27, 2024. RCTs involving DTx interventions for neuropsychiatric disorders were included. Two independent researchers extracted and analyzed the data regarding study characteristics, participant information, intervention types, and outcome measures. Results: Among a total of 67 studies included, the United States conducted the largest proportion of trials (n=36, 53.7%). A total of 54 (80.6%) studies targeted adult participants only, while 9 (13.4%) studies included adolescents and 4 studies (6.0%) focused specifically on older adults. The most commonly studied conditions were mood disorders (n=15, 22.4%), substance use disorders (n=14, 20.9%), and anxiety disorders (n=8, 11.9%). Regarding intervention types, mobile applications were the most frequently employed (n=39, 58.2%), followed by web-based programs (n=20, 29.9%) and virtual reality- based interventions (n=3, 4.5%). Cognitive behavioral therapy-based approaches were the most common therapeutic method (n=22, 32.8%), followed by behavior modification (n=8, 11.9%) and neurocognitive training (n=5, 7.5%). The Generalized Anxiety Disorder-7 was the most frequently used outcome measure. Conclusions: Our findings indicate a substantial increase of DTx clinical trials on neuropsychiatric disorders in recent years, particularly on mood and anxiety disorders. This study might be helpful for designing future clinical trials to develop DTx for treating neuropsychiatric disorders.
Abstract
Objectives: To analyze the current status and characteristics of registered randomized controlled trials (RCTs) of digital therapeutics (DTx) for neuropsychiatric disorders using the World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP). Methods: We searched the WHO-ICTRP database using the terms ‘digital therapeutics’ and ‘digital therapeutic’ up to October 27, 2024. RCTs involving DTx interventions for neuropsychiatric disorders were included. Two independent researchers extracted and analyzed the data regarding study characteristics, participant information, intervention types, and outcome measures. Results: Among a total of 67 studies included, the United States conducted the largest proportion of trials (n=36, 53.7%). A total of 54 (80.6%) studies targeted adult participants only, while 9 (13.4%) studies included adolescents and 4 studies (6.0%) focused specifically on older adults. The most commonly studied conditions were mood disorders (n=15, 22.4%), substance use disorders (n=14, 20.9%), and anxiety disorders (n=8, 11.9%). Regarding intervention types, mobile applications were the most frequently employed (n=39, 58.2%), followed by web-based programs (n=20, 29.9%) and virtual reality- based interventions (n=3, 4.5%). Cognitive behavioral therapy-based approaches were the most common therapeutic method (n=22, 32.8%), followed by behavior modification (n=8, 11.9%) and neurocognitive training (n=5, 7.5%). The Generalized Anxiety Disorder-7 was the most frequently used outcome measure. Conclusions: Our findings indicate a substantial increase of DTx clinical trials on neuropsychiatric disorders in recent years, particularly on mood and anxiety disorders. This study might be helpful for designing future clinical trials to develop DTx for treating neuropsychiatric disorders.
참고문헌 (24)
- Hong JS, "Introduction of digital therapeutics", Comput Methods Programs Biomed, 209, pp.106319~ (2021)[DOI]
- Cho CH, "Could Digital Therapeutics be a Game Changer in Psychiatry?", Psychiatry Investig, 16(2), pp.97~98 (2019)[DOI]
- Dang A, "The expanding role of digital therapeutics in the post-COVID-19 era", The Open COVID Journal, 1(1), pp.1~32 (2021)[DOI]
- Børøsund E, "Digital Cognitive Behavioral-and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer : Development Study", JMIR Form Res, 7, pp.e48719~ (2023)[DOI]
- Osborne EL, "Experiences of Using Digital Mindfulness-Based Interventions : Rapid Scoping Review and Thematic Synthesis", J Med Internet Res, 25, pp.e44220~ (2023)[DOI]
- van der Feltz-Cornelis CM, "Effectiveness of tailored digital health interventions for mental health at the workplace : A systematic review of randomised controlled trials", Eur Psychiatry, 66(Suppl 1), pp.S854~S855 (2023)[DOI]
- Hariton E, "Randomised controlled trials-the gold standard for effectiveness research : Study design : randomised controlled trials", Bjog, 125(13), pp.1716~ (2018)[DOI]
- Huh KY, "Clinical Evaluation of Digital Therapeutics : Present and Future", Healthc Inform Res, 28(3), pp.188~197 (2022)[DOI]
- Wang Y, "The Impact of Artificial Intelligence on Traditional Chinese Medicine", Am J Chin Med, 49(6), pp.1297~1314 (2021)[DOI]
- Haleem A, "Quality 4. 0 technologies to enhance traditional Chinese medicine for overcoming healthcare challenges during COVID-19", Digit Chin Med, 4(2), pp.71~80 (2021)[DOI]
- Choi M, "The Rationalization of Regulations for Advanced Medical Technology Clinical Research:Focusing on Digital Therapeutics", KICJ, ~ (2023)
- Yoo SH, "Regulatory Challenges of Digital Therapeutics", Korea Development Institute, ~ (2023)
- Korean clinical practice guideline for management of insomnia in adults, "Chung S", Korean Neuropsychiatric Association, 10~ (2019)
- Lee J, "An Integrated Literature Review of Non-pharmacological Intervention in Older Adults with Mild Cognitive Impairment", Journal of Digital Convergence, 19(3), pp.471~482 (2021)
- Churchill R, "Mindfulness-based ‘third wave’ cognitive and behavioural therapies versus treatment as usual for depression", Cochrane Database Syst Rev (2010)[DOI]
- Jo H, "A meta-analysis on the effectiveness of mindful meditation : Focused on depression and anxiety", Journal of The Korean Society of Integrative Medicine, 5(1), pp.55~66 (2017)
- Kessler RC, "Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication", Archives of general psychiatry, 62(6), pp.593~602 (2005)
- Fusar-Poli P, "Improving outcomes of first-episode psychosis : an overview", World psychiatry, 16(3), pp.251~265 (2017)
- Opportunities for Bio Digital Markers in Developer Development, "Kim JW", Korea Bio-Economy Research Center, Innovating Data Into Strategy & Business, ~ (2022)
- Samaranayake MSaI, "Improving Patient Outcomes with Advanced Digital Biomarkers", ~ (2021)
- Wang C, "Digital therapeutics from bench to bedside", NPJ Digital Medicine, 6(1), pp.38~ (2023)
- Heo EJ, "Review of Case Reports of Neuropsychiatry Disease in Oriental Medicine", Korean J Oriental Physiology & Pathology, 25(4), pp.708~714 (2011)
- Kim B, "Korean medicine clinical practice guideline for insomnia disorder", ~ (2021)
- Koffel E, "Provider perspectives of im-plementation of an evidence-based insomnia treatment in Veterans Affairs(VA)primary care : barriers, existing strategies, and future directions", Implement Sci Commun, 1(1), pp.107~ (2020)[DOI]