BACKGROUND AND AIMS: Most alcohol dependent persons have a moderate level of dependence. General practitioners (GP) hesitate to engage in this area and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open-ended internet-based cognitive behavioral program (iCBT) added to treatment as usual (TAU) is more effective than TAU only for alcohol dependent patients in primary care.

DESIGN: A two group, parallel, randomized controlled superiority trial comparing iCBT+TAU vs. TAU only, at 3- and 12-month follow-ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. 264 patients (mean age 51 years of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019.

INTERVENTIONS: Participants were randomized at a ratio of 1:1 to iCBT, as a self-help intervention added to TAU (n=132) or to TAU only (n=132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered treatment as usual at the primary care center.

MEASUREMENTS: Primary outcome was weekly alcohol consumption in grams/week at 12-month follow-up, analysed according to intention-to-treat (n=132+132). The per-protocol analysis included participants who completed at least one module of iCBT (n=102+132).

FINDINGS: There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention to treat (ITT)-analysis at 12-month follow-up [iCBT+TAU=133.56 and TAU=176.20]. In the per-protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU=107.46, TAU=176.00].

CONCLUSIONS: In Sweden, an internet-based cognitive behavioral program added to treatment as usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention to treat analysis and good evidence of a benefit in the per-protocol analysis.