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, Nozomi, So, Ryuhei, Kariyama, Kazuya, Itagaki, Yukie, Yamagishi, Takahiro, Wakuta, Akiko, Nishimura, Mamoru, Murakami, Shiho, Ogawa, Michihiro, Takebayashi, Yoshitake, Sunami, Takashi, Yumoto, Yosuke, Ito, Mitsuru, Maesato, Hitoshi, Matsushita, Sachio, and Nouso, Kazuhiro
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ALCOHOLISM treatment , *PREVENTION of alcoholism , *MOBILE apps , *REPEATED measures design , *SMARTPHONES , *PATIENT safety , *STATISTICAL sampling , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *BEHAVIOR , *DESCRIPTIVE statistics , *TELEMEDICINE , *INTERNAL medicine , *RESEARCH , *ALCOHOL drinking , *CONFIDENCE intervals - Abstract
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. 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. 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). 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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