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Randomized Controlled Trial
. 2025 Aug 12:390:e083985.
doi: 10.1136/bmj-2024-083985.

Effectiveness of screening and ultra-brief intervention for hazardous drinking in primary care: pragmatic cluster randomised controlled trial

Ryuhei So  1   2   3   4 , Kazuya Kariyama  5 , Shunsuke Oyamada  6 , Sachio Matsushita  7 , Hiroki Nishimura  8   2 , Yukio Tezuka  9 , Takashi Sunami  10 , Toshi A Furukawa  3 , Ethan Sahker  3   11 , Mitsuhiko Kawaguchi  12 , Haruhiko Kobashi  13 , Sohji Nishina  14 , Yuki Otsuka  15 , Hideyuki Kanda  16 , Yasushi Tsujimoto  3   4   17 , Yoshinori Horie  18 , Hitoshi Yoshiji  19 , Takefumi Yuzuriha  20   21 , Kazuhiro Nouso  5
Affiliations
Randomized Controlled Trial

Effectiveness of screening and ultra-brief intervention for hazardous drinking in primary care: pragmatic cluster randomised controlled trial

Ryuhei So et al. BMJ. .

Abstract

Objective: To evaluate the effectiveness of a doctor delivered screening and ultra-brief intervention (<1 minute) compared with simplified assessment only for reducing alcohol intake among patients with hazardous drinking in primary care.

Design: Pragmatic cluster randomised controlled trial.

Setting: 40 primary care clinics in Japan that did not provide routine screening and brief intervention for hazardous drinking or treatment or self-help groups for alcohol dependency.

Participants: 1133 outpatients aged 20-74 years with hazardous drinking (AUDIT-C (alcohol use disorders identification test-consumption) scores ≥5 for men and ≥4 for women). Clinic clusters were allocated to a study arm using a computer generated random sequence. Participants and staff who collected participant reported outcomes remained blinded to assignment.

Interventions: Primary care clinics were randomised to ultra-brief intervention (21 clinics, 531 patients) or simplified assessment only (19 clinics, 602 patients) groups. The intervention group comprised screening with AUDIT-C followed by brief oral advice and an alcohol information leaflet delivered in <1 minute. The control group comprised simplified assessment with AUDIT-C only.

Main outcome measures: The primary outcome was total alcohol consumption in the four weeks preceding the 24 week follow-up. Secondary outcomes included total alcohol consumption in the four weeks preceding the 12 week follow-up, and readiness to change drinking behaviour, measured at 12 and 24 weeks.

Results: At 24 weeks, the difference in total alcohol consumption between the ultra-brief intervention group (1046.9 g/4 weeks (g/4wk), 95% confidence interval (CI) 918.3 to 1175.4) and control group (1019.0 g/4wk, 893.5 to 1144.6) was 27.8 g/4wk (-149.7 to 205.4, P=0.75), with a Hedges' g of 0.02 (95% CI -0.10 to 0.14). At 12 weeks, the difference in total alcohol consumption between the intervention group (1034.1 g/4wk, 919.6 to 1148.7) and control group (979.3 g/4wk, 866.1 to 1092.4) was 54.9 g/4wk (-104.1 to 213.9, P=0.49), with a Hedges' g of 0.04 (-0.08 to 0.16).

Conclusion: This trial found no evidence to support the effectiveness of a doctor delivered ultra-brief intervention for hazardous drinking compared with simplified assessment only in primary care in Japan.

Trial registration: UMIN Clinical Trials Registry UMIN000051388.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Japan Agency for Medical Research and Development (AMED) awarded to RS, KN, and SM. No other direct support was received from any organisation for the submitted work. Financial relationships with organisations that might have an interest in the submitted work in the previous three years: RS and HN were employed by CureApp during the conduct of the study. RS received personal grants from the Osake-no-Kagaku Foundation and the Mental Health Okamoto Memorial Foundation outside the submitted work. He holds multiple pending patents (JP2022049590A, US20220084673A1, JP2022178215A, JP2022070086, JP2023074128A). SM received personal fees from CureApp, Otsuka Pharmaceutical, EA Pharma, Takeda Pharmaceutical, Yoshitomi Pharmaceutical Industries, Eisai, Nippon Shinyaku, and MSD KK outside the submitted work. TAF reports personal fees from Boehringer-Ingelheim, Daiichi Sankyo, DT Axis, Micron, Shionogi, Sony, and UpToDate, and a grant from DT Axis and Shionogi, outside the submitted work; in addition, TAF has a patent (7448125) and a pending patent (2022-082495), and has licensed intellectual properties for Kokoro-app to Mitsubishi-Tanabe. YT received lecture fees from MSD KK outside the submitted work. YH and HY received personal fees from CureApp and Otsuka Pharmaceutical outside the submitted work. TY received personal fees from CureApp, Otsuka Pharmaceutical, and Nippon Shinyaku outside the submitted work. KN received personal fees from CureApp for coordinating a pivotal study outside the submitted work. No other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Graphical depiction of procedures through the trial. ¥500 (£2.54; €2.97; $3.42). AUDIT=alcohol use disorders identification test; AUDIT-C=alcohol use disorders identification test-consumption
Fig 2
Fig 2
Flow chart of clusters and patients through the trial. The 12 week survey was sent by registered post and required signature, resulting in some delivery failures when recipients were absent. The 24 week survey was therefore sent by standard post. AUDIT-C=alcohol use disorders identification test-consumption
Fig 3
Fig 3
Total alcohol consumption (grams in four weeks (g/4wk) before follow-up) at 12 and 24 weeks. Whiskers represent standard errors
Fig 4
Fig 4
Readiness to change drinking behaviour, at 12 and 24 weeks. Whiskers represent standard errors
Fig 5
Fig 5
Subgroup analysis on total alcohol consumption (grams in four weeks (g/4wk) before follow-up) in participants with hazardous drinking according to study arm, at 24 week follow-up. AUDIT-C=alcohol use disorders identification test-consumption; CI=confidence interval
Fig 6
Fig 6
Subgroup analysis on readiness to change drinking behaviour, at 24 week follow-up. AUDIT-C=alcohol use disorders identification test-consumption; CI=confidence interval
See this image and copyright information in PMC

References

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