The Systematic Development and Pilot Randomized Evaluation of Counselling for Alcohol Problems, a Lay Counselor-Delivered Psychological Treatment for Harmful Drinking in Primary Care in India: The PREMIUM Study

Alcohol use disorders (AUD), the leading causes of the global burden of disease (Whiteford et al., 2013), cause large costs to societies attributable to health care and social harm (Rehm et al., 2009; WHO Global InfoBase Team, 2005). India, the target of market expansion by producers of alcoholic beverages (Benegal, 2005; Caetano and Laranjeira, 2006), has been experiencing an increase in alcohol availability/consumption, lowering of the age of drinking onset, and higher levels of alcohol‐related problems (Pillai et al., 2014; Prasad, 2009). AUD range from hazardous drinking, to harmful drinking and ultimately to alcohol dependence (Reid et al., 1999). The World Health Organization (WHO)'s (mhGAP‐Mental Health Gap Action Programme) guidelines advocate the use of brief advice for hazardous drinking and motivational interviewing (MI)‐based brief psychological treatments (PTs) for harmful drinking (World Health Organization, 2010). Among all mental disorders, globally, AUD have the widest treatment gap; the contact coverage of care for AUD is less than 20% in most countries (Kohn et al., 2004). Furthermore, as most patients who are in contact with services do not have their AUD recognized or receive evidence‐based treatments, the “effective” coverage gap is likely to be even larger (De Silva et al., 2014). Major reasons for this treatment gap are the lack of mental health specialists skilled in delivering PT and the contextual barriers toward delivery of PT in low resource settings (Knapp et al., 2006; World Health Organization, 2005). Task sharing (rational redistribution of tasks among health workforce teams) with nonspecialist health workers is advocated to address such human resource shortages (Lawn et al., 2008; Lewin et al., 2005). Eng and colleagues (1997) have conceptualized nonspecialist health workers on a spectrum from the “natural helper” (unpaid community members) at one end to the “para‐professional” (paid workers with minimal qualifications, trained, and demonstrating acceptable levels of standardized competencies) at the other. Community health workers have demonstrated effectiveness in increasing access to care (Swider, 2002; Viswanathan et al., 2010), for example, promoting immunization uptake and breastfeeding, improving tuberculosis treatment outcomes, and reducing child morbidity and mortality (Lewin et al., 2010). In the field of mental health, there is robust evidence that lay counselors (a person without professional qualification in mental health care) can be trained to deliver PT effectively for people with depressive and anxiety disorders in low‐ and middle‐income countries (LMIC) (van Ginneken et al., 2013). There is also evidence demonstrating that PT developed in Western cultural contexts retain their effectiveness in different cultural contexts, when adapted following a systematic methodology (Chowdhary et al., 2013). A key Grand Challenge in Global Mental Health is to design a methodology for the development and evaluation of PT by lay counselors (Collins et al., 2011). The purpose of this paper is to define a PT “discovery” process in order to develop a brief PT for harmful drinking to be delivered by lay counselors in routine primary care settings. The treatment was developed to address harmful drinking in men because the vast majority of persons with any kind of AUD in the region were men (Murthy et al., 2010). This work is a part of the PRogrammE for Mental health Interventions in Under‐resourced health systeMs (PREMIUM) whose guiding principles are to develop PT based on both global and contextually relevant evidence and with emphasis on both acceptability to patients and feasibility for delivery by lay counselors in routine healthcare settings (Patel et al., 2014). In PREMIUM, the lay counselors are “para‐professionals” as described by Eng and colleagues. (1997). The fieldwork was carried out in Satara and Goa in India. Goa is a small state on the west coast of India with a population of over 1.4 million; Satara is a semi‐urban district in the state of Maharashtra with a population of over 2.8 million. All research procedures with human participants were approved by the Institutional Review Boards (IRB) of Sangath and the London School of Hygiene & Tropical Medicine, and the Health Ministry Screening Committee of the Indian Council of Medical Research, and written informed consent was obtained from all participants.