수면 장애가 있는 환자에게 적용한 디지털 치료기기의 임상적 유효성에 대한 체계적 문헌고찰: 대조군분류에 따른 하위 분석
A Systematic Review on the Clinical Efficacy of Digital Therapeutics for Sleep Disorders: Subgroup Analysis by Control Groups
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.
Abstract
Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.
참고문헌 (66)
- 정석훈, "불면증 약물 치료의 최적화 방안", Journal of sleep medicine, 13(1), pp.1~7 (2016), 대한수면연구학회
- 김석주, "불면증의 약물치료", 대한의사협회지, 52(7), pp.719~726 (2009), 대한의사협회
- Clinical Practice Guidelines Committee of Korean Neuro Psychiatric Association, "Korean version of insomnia clinical practice guidelines Diagnosis and treatment of insomnia", Korean Neuro Psychiatric Association, 23~66 (2019)
- Riemann D, "European guideline for the diagnosis and treatment of insomnia", J Sleep Res, 26(6), pp.675~700 (2017)
- Qaseem A, "Management of chronic insomnia disorder in adults: A clinical practice guideline from the American college of physicians", Ann. Intern. Med, 165(2), pp.125~133 (2016)
- Ström, L, "Internet-based treatment for insomnia : a controlled evaluation", Journal of consulting and clinical psychology, 72(1), pp.113~120 (2004)
- Darden M, "Cost-effectiveness of digital cognitive behavioral therapy(Sleepio)for insomnia : a Markov simulation model in the United States", Sleep, 44(4) (2021)
- (2022)[URL]
- Soh HL, "Efficacy of digital cognitive behavioural therapy for insomnia : a meta-analysis of randomised controlled trials", Sleep Med, 75, pp.315~325 (2020)
- "Digital therapeutic device approval and review guidelines" (2020)[URL]
- "BigHealth"[URL]
- "Pear Therapeutics"[URL]
- "AIMMED"[URL]
- "WELT Corp"[URL]
- Page MJ, "The PRISMA 2020statement: An updated guideline for reporting systematic reviews", BMJ (Clinical research ed.), 372, pp.n71~ (2021)
- SY Kim, "Health Technology Assessment Methodology : Systematic Review", National Evidence- based Healthcare Collaborating Agency, ~ (2020)
- Schutte-Rodin S, "Clinical guideline for the evaluation and management of chronic insomnia in adults", J Clin Sleep Med, 4(5), pp.487~504 (2008)
- "Chapter 8: Assessing risk of bias in a randomized trial" (2022)[URL]
- Kim SY, "NECA’s guidance for assessing tools of risk of bias", National Evidence Based Healthcare Collaborating Agency, 1~178 (2021)
- 안은진, "Introduction to systematic review and meta-analysis", Korean Journal of Anesthesiology, 71(2), pp.103~112 (2018), 대한마취통증의학회
- Jacob Cohen, "Statistical power analysis for the behavioral sciences", pp.117~ (1998), Lawrence Erlbaum Associates
- Vedaa Ø, "Effects of digital cognitive behavioral therapy for insomnia on insomnia severity : a large-scale randomized controlled trial", Lancet Digit Health, 2(8), pp.e397~e406 (2020)
- Kallestad H, "Mode of delivery of Cognitive Behavioral Therapy for Insomnia : a randomized controlled noninferiority trial of digital and face-to-face therapy", Sleep, 44(12) (2021)
- Morris J, "Internet-delivered cognitive behavior therapy for anxiety and insomnia in a higher education context", Anxiety Stress Coping, 29(4), pp.415~431 (2016)
- Lancee J, "Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia : A Randomized Controlled Trial", Cognitive behavior therapy, 44(5), pp.406~422 (2015)
- Thiart H, "Log in and breathe out : internetbased recovery training for sleepless employees with work-related strain-results of a randomized controlled trial", Scandinavian journal of work, environment & health, 41(2), pp.164~174 (2015)
- Vincent N, "Logging on for better sleep : RCT of the effectiveness of online treatment for insomnia", Sleep, 32(6), pp.807~815 (2009)
- Black DS, "Mindfulness meditation and improvement in sleep quality and daytime impairment among older adults with sleep disturbances : a randomized clinical trial", JAMA Intern Med, 175(4), pp.494~501 (2015)
- Zhang JX, "Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial", Explore, 11(3), pp.180~185 (2015)
- Lorenz N, "Randomized Controlled Trial to Test the Efficacy of an Unguided Online Intervention with Automated Feedback for the Treatment of Insomnia", Behav Cogn Psychother, 47(3), pp.287~302 (2019)
- Siebmanns S, "The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease : A randomized controlled trial with 6-month follow-up", Nursing open, 8(4), pp.1755~1768 (2021)
- Vestergaard CL, "The effect of sleepwake intraindividual variability in digital cognitive behavioral therapy for insomnia : a mediation analysis of a large-scale RCT", Sleep, 44(10), pp.zsab118~ (2021)
- Abdelaziz EM, "Efficacy of Internet-based cognitive behavioral therapy on sleeping difficulties in menopausal women : A randomized controlled trial", Perspectives in psychiatric care, 58(4), pp.1907~1917 (2022)
- Behrendt D, "Efficacy of a Self-Help Web-Based Recovery Training in Improving Sleep in Workers : Randomized Controlled Trial in the General Working Population", J Med Internet Res, 22(1), pp.e13346~ (2020)
- Sunnhed R, "Comparing internetdelivered cognitive therapy and behavior therapy with telephone support for insomnia disorder : a randomized controlled trial", Sleep, 43(2) (2020)
- Cain MA, "A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women", Behav Sleep Med, 18(4), pp.477~487 (2020)
- Kalmbach DA, "A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women", Sleep Med, 72, pp.82~92 (2020)
- Espie CA, "A randomized, placebocontrolled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application", Sleep, 35(6), pp.769~781 (2012)
- Glozier N, "Adjunctive Internetdelivered cognitive behavioural therapy for insomnia in men with depression : A randomised controlled trial", The Australian and New Zealand journal of psychiatry, 53(4), pp.350~360 (2019)
- Bernstein AM, ""Go! to Sleep" : A Web-Based Therapy for Insomnia", Telemed J E Health, 23(7), pp.590~599 (2017)
- Rajabi Majd N, "Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia : Randomized Controlled Trial", J Med Internet Res, 22(4), pp.e15841~ (2020)
- Sveen J, "Feasibility and preliminary efficacy of guided internet-delivered cognitive behavioral therapy for insomnia after the loss of a child to cancer:Randomized controlled trial", Internet interventions, 25, pp.100409~ (2021)
- Espie CA, "Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Wellbeing, and Sleep-Related Quality of Life: A Randomized Clinical Trial", JAMA Psychiatry, 76(1), pp.21~30 (2019)
- Faaland P, "Digital cognitive behaviour therapy for insomnia(dCBT-I) : Chronotype moderation on intervention outcomes", J Sleep Res, 31(5), pp.e13572~ (2022)
- Cheng P, "Depression prevention in digital cognitive behavioral therapy for insomnia : Is rumination a mediator?", J Affect Disord, 273, pp.434~441 (2020)
- Chow PI, "Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia", Sleep Med, 47, pp.77~85 (2018)
- De Bruin EJ, "Differential effects of online insomnia treatment on executive functions in adolescents", Sleep Med, 16(4), pp.510~520 (2015)
- Van der Zweerde T, "Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms", Psychol Med, 49(3), pp.501~509 (2019)
- Ritterband LM, "Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention with 1-Year Follow-up : A Randomized Clinical Trial", JAMA Psychiatry, 74(1), pp.68~75 (2017)
- Sato D, "Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia : 3-Arm Randomized Controlled Trial", J Med Internet Res, 24(2), pp.e28747~ (2022)
- Ritterband LM, "Efficacy of an Internet-based behavioral intervention for adults with insomnia", Arch Gen Psychiatry, 66(7), pp.692~698 (2009)
- Mindell JA, "Efficacy of an internet-based intervention for infant and toddler sleep disturbances", Sleep, 34(4), pp.451~458 (2011)
- De Bruin EJ, "Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition", Sleep, 38(12), pp.1913~1926 (2015)
- Kaldo V, "Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial, Behaviour research and therapy", Behav Res Ther, 71, pp.90~100 (2015)
- Van Straten A, "Guided Internetdelivered cognitive behavioural treatment for insomnia : a randomized trial", Psychol Med, 44(7), pp.1521~1532 (2014)
- Lancee J, "Guided online or face-to-face cognitive behavioral treatment for Insomnia : A Randomized Wait-List Controlled Trial", Sleep, 39(1), pp.183~191 (2016)
- Ritterband LM, "Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia", Psychooncology, 21(7), pp.695~705 (2012)
- Taylor DJ, "Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel : A Randomized Clinical Trial", Sleep, 40(6) (2017)
- Ström L, "Internet-based treatment for insomnia : a controlled evaluation", J Consult Clin Psychol, 72(1), pp.113~120 (2004)
- Zachariae R, "Efficacy of internet-delivered cognitive-behavioral therapy for insomnia-A systematic review and meta-analysis of randomized controlled trials", Sleep Med Rev, 30, pp.1~10 (2016)
- Luik AI, "Digital Cognitive Behavioral Therapy(dCBT)for Insomnia : a State-of-the-Science Review", Curr Sleep Med Rep, 3(2), pp.48~56 (2017)
- Hasan F, "Comparative efficacy of digital cognitive behavioral therapy for insomnia : A systematic review and network meta-analysis", Sleep Med Rev, 61, pp.101567~ (2022)
- Erten Uyumaz B, "A Review of Digital Cognitive Behavioral Therapy for Insomnia(CBT-I Apps) : Are They Designed for Engagement?", Int J Environ Res Public Health, 18(6), pp.2929~ (2021)
- Lee S, "Digital cognitive behavioral therapy for insomnia on depression and anxiety : a systematic review and meta-analysis", NPJ Digital Medicine, 6(1), pp.52~ (2023)
- Yuan Y, "Systematic reviews: the good, the bad, and the ugly", Am J Gastroenterol, 104(5), pp.1086~1092 (2009)
- Kim SY, "NECA’s guidance for undertaking systematic reviews and meta-analyses for intervention", National Evidence-based Healthcare Collaborating Agency, 19~271 (2011)
