Background Psychotherapy is proven efficacious for the treatment of alcohol use disorder (AUD). However, the patient-perceived importance of its effect is not fully appreciated in the evidence base. The smallest worthwhile difference (SWD) represents the smallest beneficial effect of an intervention that patients deem worthwhile in exchange for the harms, expenses, and inconveniences associated with the intervention, and facilitates the interpretation of patient perceived worthiness of an intervention.

Methods The proposed study will estimate the SWD of NIAAA recommended psychotherapies for AUD treatment with English-speaking American respondents aged 18 and older. Primary participants will be recruited using the Prolific research crowdsourcing site. The SWD will be estimated using the Benefit-Harm Trade-off Method, presenting survey respondents with variable, hypothetical magnitudes of psychotherapy outcomes to find the smallest acceptable effect over a natural remission alternative. The overall average SWD, and subgroup distributions by participant AUD treatment experiences and AUD symptomology will be described. Secondary findings will estimate the smallest recommendable risk difference for AUD psychotherapy from providers and criminal justice professionals.

Expected Results We expect to find an estimate of the SWD for AUD psychotherapy. Further, we expect that the SWD will vary between clinical subgroups based on AUD symptomology and treatment experiences. We expect differences in SWDs between the general population and those of providers and criminal justice professionals. Findings from this project will inform the treatment decision process about psychotherapy during the clinical consultation for people with AUD.

ES is supported by a grant from the Japan Society for the Promotion of Science (grant 24K20239). RS is employed by CureApp, a software as a medical device (SaMD) manufacturing company. CureApp has developed a SaMD for alcohol dependence. 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). YL is employed in the Department of Next-Generation Organ Transplantation, The University of Tokyo Hospital, which is an endowed department supported by the N28 General Incorporated Association, a non-profit organization in Japan. KO reports consultant fees and lecture fees from Astellas Pharma and Kyorin Pharmaceutical, consultant fees from Kyowa Hakko Kirin, lecture fees from Ono Pharmaceutical, Pfizer, Nippon Shinyaku, and Kissei Pharmaceutical, outside the submitted work. TAF reports personal fees from Boehringer-Ingelheim, DT Axis, Kyoto University Original, Shionogi, SONY and UpToDate, and a grant from Shionogi, outside the submitted work; In addition, TAF has patents 2020-548587 and 2022-082495 pending, and intellectual properties for Kokoro-app licensed to Mitsubishi-Tanabe. DE is on the scientific advisory boards of mental-healthcare companies ViviHealth and Innerworld and is a partner in Peer Recovery Consultants. All the other authors declared no conflict of interest.

This study was funded by the Kyoto University Graduate School of Medicine.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Graduate School of Medicine, Faculty of Medicine, and Hospital Medical Ethics Committee of Kyoto University gave ethical approval for this work (R5355).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are available upon reasonable request to the authors.