{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T17:27:53Z","timestamp":1786123673611,"version":"build-2736575974"},"reference-count":34,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Illicit drug use has been rapidly increasing in South Korea, particularly among individuals in their 20s, contributing to a growing burden of substance use disorder (SUD). However, treatment infrastructure remains limited. Nationwide, only a small number of inpatient treatment hospitals are available, and treatment capacity in the Seoul metropolitan area is insufficient to meet growing demand. In addition, community-based addiction services are scarce, creating barriers to continuous care. Digital therapeutics (DTx) have emerged as a promising approach to improve treatment accessibility and continuity of care. In particular, cognitive behavioral therapy (CBT)\u2013based DTx such as RESET-O, developed in the United States and authorized by the US Food and Drug Administration, have demonstrated clinical benefits in supporting addiction recovery. Building on this concept, our team developed D-STOP, a CBT-based DTx intervention designed to support individuals with SUD in the Korean clinical context.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to evaluate the efficacy of D-STOP as an adjunctive DTx intervention for patients with SUD.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This study is a randomized controlled clinical trial designed to evaluate the efficacy of D-STOP in individuals diagnosed with SUD. Following an initial screening assessment, 118 participants meeting the diagnostic criteria will be enrolled. Participants will be recruited from psychiatry departments at addiction treatment and clinical care institutions in Chuncheon, Seoul, Daegu, and Changnyeong, South Korea. During the 12-week intervention period, the experimental group will receive D-STOP in addition to treatment as usual, whereas the control group will receive treatment as usual alone. D-STOP delivers structured CBT-based modules and motivational enhancement interventions through a digital platform. During scheduled study visits, participants will also receive therapeutic feedback from psychiatrists or trained study staff. The primary end point is the abstinence success rate during weeks 9 to 12 of treatment. Logistic regression analysis will be used to estimate treatment effects and evaluate superiority compared with the control group.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study protocol was approved by the institutional review board of Hallym University Chuncheon Sacred Heart Hospital on April 14, 2025. Funding began on April 1, 2023. Data collection started on August 4, 2025, and is expected to be completed by November 30, 2026. As of March 6, 2026, a total of 65 participants have been enrolled. An interim analysis of the primary efficacy outcome has been conducted based on the data available at the time of analysis; however, statistical significance has not been established due to the limited sample size. The final analysis is expected to be published in April 2027.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n DTx have the potential to expand access to evidence-based addiction treatment in resource-constrained settings. This study will provide clinical evidence on the efficacy and feasibility of D-STOP as a digital treatment support tool for patients with SUD.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/85458","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T09:55:09Z","timestamp":1774432509000},"page":"e85458-e85458","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy of Cognitive Behavioral Therapy\u2013Based Digital Therapeutics for Substance Use Disorder: Protocol for a Randomized Controlled Trial"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-1557-0011","authenticated-orcid":false,"given":"Yong Chan","family":"Jeong","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-6194-6137","authenticated-orcid":false,"given":"Byoung-Kwon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8635-0425","authenticated-orcid":false,"given":"Jae-Kyoung","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-2540-8041","authenticated-orcid":false,"given":"Ye-Jin","family":"Jang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-6375-0856","authenticated-orcid":false,"given":"Do hoon","family":"Kwon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5419-8321","authenticated-orcid":false,"given":"Tae Kyung","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0968-087X","authenticated-orcid":false,"given":"Boung Chul","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9349-7661","authenticated-orcid":false,"given":"Haemin","family":"Seo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4584-5333","authenticated-orcid":false,"given":"Ha Yeong","family":"Choi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0000-1671-4850","authenticated-orcid":false,"given":"Sang-Kyu","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,8,7]]},"reference":[{"key":"R1","unstructured":"National Center for Mental Health Research. Compendium of key addiction indicators 2023. Ministry of Health and Welfare; 2023. URL: https:\/\/www.nmhc.or.kr\/sub.php?id=file&mode=view&menukey=18&idx=3603&page=1"},{"key":"R2","unstructured":"Ministry of Health and Welfare. Status of treatment and rehabilitation institutions for narcotics addicts 2024. Ministry of Health and Welfare; 2024. URL: https:\/\/nmhc.or.kr\/sub.php?id=file&mode=view&menukey=19&ctgrstr=%EC%A1%B0%EC%82%AC%EC%97%B0%EA%B5%AC&idx=3637&page=1"},{"key":"R3","unstructured":"Supreme Prosecutors\u2019 Office of the Republic of Korea. White paper on narcotics crime 2023. Supreme Prosecutors\u2019 Office; 2023. URL: https:\/\/nsp.nanet.go.kr\/plan\/subject\/detail.do?nationalPlanControlNo=PLAN0000046630"},{"issue":"5","key":"R4","doi-asserted-by":"publisher","first-page":"1071","DOI":"10.1111\/dar.13806","article-title":"Experiences of stigma and subsequent reduced access to health care among women who inject drugs","volume":"43","author":"Brener","journal-title":"Drug Alcohol Rev"},{"key":"R5","unstructured":"Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health. Substance Abuse and Mental Health Services Administration; 2022. URL: https:\/\/archive.org\/details\/key-2021 [Accessed 25-04-2026]"},{"key":"R6","doi-asserted-by":"publisher","DOI":"10.1016\/j.dadr.2024.100255","article-title":"Association of economic and racial segregation with restricted buprenorphine dispensing in U.S. community pharmacies","volume":"12","author":"Moon","journal-title":"Drug Alcohol Depend Rep"},{"issue":"2","key":"R7","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1037\/cps0000131","article-title":"An evaluation of cognitive behavioral therapy for substance use disorder: a systematic review and application of the society of clinical psychology criteria for empirically supported treatments","volume":"30","author":"Boness","journal-title":"Clin Psychol (New York)"},{"issue":"2","key":"R8","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1176\/appi.ajp.2007.06111851","article-title":"A meta-analytic review of psychosocial interventions for substance use disorders","volume":"165","author":"Dutra","journal-title":"Am J Psychiatry"},{"key":"R9","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2025.1695702","article-title":"Efficacy of cognitive behavioral therapy for stimulant use disorders: a systematic review and meta-analysis","volume":"16","author":"Kim","journal-title":"Front Psychiatry"},{"issue":"4","key":"R10","doi-asserted-by":"publisher","first-page":"516","DOI":"10.15288\/jsad.2009.70.516","article-title":"Cognitive-behavioral treatment with adult alcohol and illicit drug users: a meta-analysis of randomized controlled trials","volume":"70","author":"Magill","journal-title":"J Stud Alcohol Drugs"},{"issue":"8","key":"R11","doi-asserted-by":"publisher","first-page":"847","DOI":"10.1037\/adb0000311","article-title":"Cognitive behavioral interventions for alcohol and drug use disorders: through the stage model and back again","volume":"31","author":"Carroll","journal-title":"Psychol Addict Behav"},{"issue":"3","key":"R12","doi-asserted-by":"publisher","first-page":"511","DOI":"10.1016\/j.psc.2010.04.012","article-title":"Cognitive behavioral therapy for substance use disorders","volume":"33","author":"McHugh","journal-title":"Psychiatr Clin North Am"},{"key":"R13","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.clinpsy.1.102803.143833","article-title":"Motivational interviewing","volume":"1","author":"Hettema","journal-title":"Annu Rev Clin Psychol"},{"issue":"2","key":"R14","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1177\/1049731509347850","article-title":"A meta-analysis of motivational interviewing: twenty-five years of empirical studies","volume":"20","author":"Lundahl","journal-title":"Res Soc Work Pract"},{"key":"R15","doi-asserted-by":"publisher","DOI":"10.1016\/j.dadr.2025.100332","article-title":"Real-world effectiveness of Motivational Enhancement for Engagement in Treatment (MEET) to improve substance use disorder care transitions","volume":"15","author":"Crandal","journal-title":"Drug Alcohol Depend Rep"},{"issue":"1","key":"R16","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1111\/add.16325","article-title":"Behavioural self-control training versus motivational enhancement therapy for individuals with alcohol use disorder with a goal of controlled drinking: a randomized controlled trial","volume":"119","author":"Hammarberg","journal-title":"Addiction"},{"issue":"3","key":"R17","doi-asserted-by":"publisher","first-page":"448","DOI":"10.1037\/a0035798","article-title":"Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial","volume":"82","author":"Garland","journal-title":"J Consult Clin Psychol"},{"issue":"4","key":"R18","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1080\/08897070903250084","article-title":"Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial","volume":"30","author":"Bowen","journal-title":"Subst Abus"},{"key":"R19","doi-asserted-by":"publisher","DOI":"10.1016\/j.josat.2023.209116","article-title":"Efficacy of mindfulness-based relapse prevention in a sample of veterans in a substance use disorder aftercare program: a randomized controlled trial","volume":"152","author":"Killeen","journal-title":"J Subst Use Addict Treat"},{"issue":"3","key":"R20","doi-asserted-by":"publisher","first-page":"244","DOI":"10.1016\/j.ctim.2013.01.008","article-title":"A narrative review of yoga and mindfulness as complementary therapies for addiction","volume":"21","author":"Khanna","journal-title":"Complement Ther Med"},{"key":"R21","doi-asserted-by":"publisher","DOI":"10.1186\/1471-244X-8-41","article-title":"Relaxation training for anxiety: a ten-years systematic review with meta-analysis","volume":"8","author":"Manzoni","journal-title":"BMC Psychiatry"},{"issue":"6","key":"R22","doi-asserted-by":"publisher","first-page":"771","DOI":"10.1080\/00952990.2024.2400934","article-title":"Digital cognitive-behavioral therapy for substance use: systematic review and meta-analysis of randomized controlled trials","volume":"50","author":"Gregory","journal-title":"Am J Drug Alcohol Abuse"},{"issue":"5","key":"R23","doi-asserted-by":"publisher","first-page":"566","DOI":"10.1001\/jamapsychiatry.2013.4642","article-title":"A smartphone application to support recovery from alcoholism: a randomized clinical trial","volume":"71","author":"Gustafson","journal-title":"JAMA Psychiatry"},{"key":"R24","unstructured":"De novo classification request for reSET. U.S. Food and Drug Administration; URL: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/DEN160018.pdf [Accessed 25-04-2026]"},{"issue":"6","key":"R25","doi-asserted-by":"publisher","first-page":"683","DOI":"10.1176\/appi.ajp.2014.13081055","article-title":"Internet-delivered treatment for substance abuse: a multisite randomized controlled trial","volume":"171","author":"Campbell","journal-title":"Am J Psychiatry"},{"key":"R26","doi-asserted-by":"crossref","unstructured":"Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Publishing; 2013. [doi: 10.1176\/appi.books.9780890425596]","DOI":"10.1176\/appi.books.9780890425596"},{"key":"R27","unstructured":"The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. World Health Organization. 1992. URL: https:\/\/www.who.int\/publications\/i\/item\/9241544228 [Accessed 25-04-2026]"},{"issue":"2","key":"R28","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1080\/01488376.2013.875096","article-title":"Validating a Korean version of the Drug Abuse Screening Test-10 (DAST-10)","volume":"40","author":"Kim","journal-title":"J Soc Serv Res"},{"issue":"3","key":"R29","doi-asserted-by":"publisher","first-page":"368","DOI":"10.1037\/h0090198","article-title":"Stages of change in psychotherapy: measurement and sample profiles","volume":"20","author":"McConnaughy","journal-title":"Psychotherapy"},{"issue":"1","key":"R30","doi-asserted-by":"publisher","first-page":"157","DOI":"10.14819\/krscs.2024.34.1.6.157","article-title":"Predictive validity of the URICA-DO: Korean version of the Stages of Recovery Scale for Drug Offenders","volume":"98","author":"Chung","journal-title":"Correct Rev"},{"issue":"6","key":"R31","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1111\/j.1600-0447.1983.tb09716.x","article-title":"The Hospital Anxiety and Depression Scale","volume":"67","author":"Zigmond","journal-title":"Acta Psychiatr Scand"},{"issue":"2","key":"R32","first-page":"289","volume":"38","author":"Oh","journal-title":"J Korean Neuropsychiatr Assoc"},{"key":"R33","unstructured":"Kim YK . Development and validation of the cognitive reappraisal questionnaire (CRQ) [master\u2019s thesis]. Seoul National University; 2019. URL: https:\/\/s-space.snu.ac.kr\/handle\/10371\/151281?mode=full [Accessed 05-06-2026]"},{"issue":"2","key":"R34","doi-asserted-by":"publisher","first-page":"89","DOI":"10.4306\/jknpa.2017.56.2.89","article-title":"The reliability and validity of the Korean version of Behavioral Activation for Depression Scale","volume":"56","author":"Oh","journal-title":"J Korean Neuropsychiatr Assoc"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T15:53:12Z","timestamp":1786117992000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e85458"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,7]]},"references-count":34,"URL":"https:\/\/doi.org\/10.2196\/85458","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,7]]},"article-number":"v15i5e85458"}}