A smartphone app-based intervention combined with face-to-face sessions for alcohol dependence at internal medicine clinics: A randomized controlled trial

• Published in: General hospital psychiatry 2024-09, Vol.90, p.68-75
• Main Authors: 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, Nouso, Kazuhiro
• Format: Article
• Language: English
• Subjects: Alcohol dependence; Alcohol use disorder; Digital therapeutics; Heavy drinking; Mobile applications
• ISSN: 0163-8343; 1873-7714; 1873-7714
• DOI: 10.1016/j.genhosppsych.2024.07.003

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.