Date Published: September 12, 2017
Publisher: Public Library of Science
Author(s): Abhijit Nadkarni, Helen A. Weiss, Benedict Weobong, David McDaid, Daisy R. Singla, A-La Park, Bhargav Bhat, Basavaraj Katti, Jim McCambridge, Pratima Murthy, Michael King, G. Terence Wilson, Betty Kirkwood, Christopher G. Fairburn, Richard Velleman, Vikram Patel, Alexander C. Tsai
Abstract: BackgroundCounselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator ‘readiness to change’ on clinical outcomes.Methods and findingsMale primary care attendees aged 18–65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised 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 mean 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 score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than 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 of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC 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 1 month’s wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect −6.014 [95% CI −13.99, −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 the examination of mediation effects of only 1 mediator and in only half of our sample.ConclusionsCAP’s superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.Trial registrationISRCTN registry ISRCTN76465238
Partial Text: Alcohol use disorders (AUDs)  contribute substantially to the disability and premature mortality attributable to mental and substance use disorders . In low- and middle-income countries (LMICs), alcohol use is a leading risk factor for disease and injuries . Harmful drinking is also associated with socioeconomic consequences for the drinker (e.g., loss of earnings), harm to others (e.g., domestic violence), and harm to society at large (e.g., loss of productive years of life to death and disability) . Economic growth in India has made it a key target for trans-national producers of alcoholic beverages, resulting in increased alcohol availability, alcohol consumption, and alcohol-related problems [4,5]. Although the less severe forms of AUDs (hazardous or harmful drinking) affect a larger proportion of the population than the more severe AUD (dependent drinking), the policy response in India remains focused predominantly on the latter . There is substantial evidence for the effectiveness of brief psychological treatments for AUDs , and, with larger effect sizes in studies that have excluded dependent drinkers , such interventions are recommended for scaling up in primary care . However, the vast majority of people in LMICs, including India, lack access to such interventions; for example, the recent National Mental Health Survey of India reported that 86% of persons with AUDs had not received any treatment in the previous 12 months .
The methods are described in detail in the protocol (S1 Text)  and the 3-month outcome paper , and a summary is presented below. The trial was conducted in alignment with the protocol (ISRCTN76465238) (S1 Text) , which was approved by the trial steering committee (TSC). Approval for the conduct of the trial was obtained from the institutional review boards of the London School of Hygiene & Tropical Medicine, Sangath (the implementing institution in India), and the Indian Council of Medical Research. Written (or witnessed, if the participant was illiterate) informed consent was mandatory for enrolment. This study is reported as per CONSORT guidelines (S1 CONSORT Checklist).
We report on the sustained effects, cost-effectiveness, and role of readiness to change in mediating the effectiveness of CAP, a brief psychological treatment for harmful drinking delivered by lay counsellors in routine primary care settings, in a randomised controlled trial in India. Our findings demonstrate (1) that the effects of CAP on remission and abstinence outcomes were not just maintained at 12 months but enhanced in comparison to those observed at 3 months post-enrolment , indicating evidence of sustained recovery among harmful drinkers, (2) that the healthcare costs of provision of CAP are offset over 12 months, (3) that CAP produces gains in terms of productivity that have real implications for the individuals involved and for the larger society in which they are embedded, and (4) that patient-reported readiness to change at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months.