1. A smartphone app-based intervention combined with face-to-face sessions for alcohol dependence at internal medicine clinics: A randomized controlled trial.
- Author
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Miyake N, So R, Kariyama K, Itagaki Y, Yamagishi T, Wakuta A, Nishimura M, Murakami S, Ogawa M, Takebayashi Y, Sunami T, Yumoto Y, Ito M, Maesato H, Matsushita S, and Nouso K
- Subjects
- Humans, Male, Female, Middle Aged, Adult, Outcome Assessment, Health Care, Telemedicine, Alcoholism therapy, Mobile Applications, Smartphone, Internal Medicine
- Abstract
Background: Addressing the limited access to treatments for alcohol dependence, we developed ALM-002, a therapeutic application to be "prescribed" for non-abstinence-oriented treatment in internal medicine settings. Our objective was to preliminarily assess the efficacy and safety of ALM-002., Methods: In a multicenter, open-label randomized controlled trial, participants aged ≥20 with alcohol dependence and daily alcohol consumption exceeding 60 g for men and 40 g for women, without severe complications, were randomly assigned to either the intervention group using ALM-002 or the treatment-as-usual control group. Participant in both groups received individual face-to-face sessions by physicians at weeks 0, 4, 8, and 12. The primary endpoint was the change in heavy drinking days (HDDs) from week 0 to week 12. A mixed model for repeated measures was employed., Results: We enrolled 43 participants: 22 in the intervention group and 21 in the control group. A significant reduction in HDDs every 4 weeks from week 0 to week 12 was observed, with a between-group difference of -6.99 days (95% CI: -12.4 to -1.6 days, standardized mean difference: -0.80)., Conclusions: These results indicate the potential of ALM-002 as a viable treatment for alcohol dependence. Further studies are needed to evaluate the clinical potential of ALM-002., Competing Interests: Declaration of competing interest RS reports personal fees from CureApp, Inc., during the conduct of the study; grants from Osake-no-Kagaku Foundation, grants from The Mental Health Okamoto Memorial Foundation, grants from Kobayashi Magobe Memorial Medical Foundation, personal fees from Otsuka Pharmaceutical Co., Ltd., personal fees from Nippon Shinyaku Co., Ltd., personal fees from Takeda Pharmaceutical Co., Ltd., outside the submitted work; In addition, RS has a patent JP2022049590A, US20220084673A1 pending, a patent JP2022178215A pending, a patent JP2022070086 pending, and a patent JP2023074128A pending. YI, TY received a research funding from CureApp Inc. outside the submitted work. SMa and KN received personal fees for coordinating a pivotal study from Cure App Inc. outside the submitted work., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
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