Background Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among primary care male attendees with harmful drinking in a setting in India. We evaluate the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator of ‘readiness to change’ on clinical outcomes. Methods and Findings Male primary care attenders aged 18-65 screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomized to either CAP plus Enhanced Usual Care (EUC) (n=188) or EUC alone (n=189), of whom 89% completed assessments at 3 months and 84% at 12 months. Primary outcomes were remission and daily standard ethanol consumed in the past 14 days; and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT<8: 54.3% vs 31.9%; aPR 1.71 [95% CI 1.32-2.22]; p<0.001) and abstinence in the past 14 days (45.1% vs 26.4%; aOR 1.92 [95% CI 1.19-3.10]; p=0.008) being significantly higher in the EUC plus CAP group than in the EUC alone group. They also fared better on secondary outcomes including recovery (AUDIT<8 at 3 and 12 months: 27.4% vs 15.1%; aPR 1.90 [95% CI 1.21-3.0]; p=0.006); and percent of days abstinent (mean% [SD] 71.0 [38.2] vs 55. 0 [39.8]; AMD 16.1 [95% CI 7.1-25.0]; p=0.001). The intervention effect for remission was higher at 12 months compared to that at 3 months (aPR 1·50 [95% CI 1·09–2·07]. There was no evidence of an intervention effect on Patient Health Questionnaire-9 score, suicidal behaviour, percentage days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule II score, days unable to work, and perpetration of intimate partner violence. Economic analyses indicated that CAP was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to one month’s wages for an unskilled manual worker in Goa. Readiness to change levels at 3 months mediated the effects of CAP on mean daily drinking at 12 months (Indirect effect -6.014, 95% CI -13.99- to -0.046). Serious adverse events were infrequent and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and examination of mediation effects of only one mediator and in only half of our sample. Conclusions CAP’s superiority over EUC at the end of treatment was largely stable over time and mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)