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)

서지정보

· 발행기관 : 대한한방신경정신과학회
· 수록지 정보 : 동의신경정신과학회지 / 35권 / 4호 / 429 ~ 438페이지
· 저자명 : 권찬영, 이경은, 김민재

초록

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.

영어초록

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.

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