Innovation summary

Alcohol use disorders contribute substantially to disability and are responsible for 7.9% of years lost to disability globally1. The prevalence of alcohol use disorders and alcohol-attributable mortality are high in Low- and middle- income countries like India2.

There is poor access to effective treatments for hazardous drinking in India, where a recent national survey reported a treatment gap of 86% for AUDs3. This is due to lack of skilled professionals4 and prevalent concerns regarding contextual appropriateness and generalisability of existing psychological interventions developed in the West5.

Under the Programme for Mental Health Interventions in Under-resources health systems (PREMIUM)6, a lay-counsellor delivered intervention was developed to address harmful drinking in men and delivered in routine primary care settings through the following systematic research processes:

  • A synthesis of global and local evidence base, contextually appropriate treatment strategies and theoretical framework for developing a psychological intervention addressing harmful drinking
  • An acceptability and feasibility study of the CAP intervention delivered within Indian primary care settings
  • A Randomised Controlled Trial to assess the effectiveness and cost-effectiveness of the CAP intervention when delivered by lay counsellors to harmful drinkers in primary care in Goa, India

Impact summary

  • In the RCT, a total of 188 received the CAP intervention
  • Compared to Enhanced Usual Care (EUC), CAP led to significantly higher remission, abstinence, and percentage of days abstinent at 3 months post-randomisation. These positive outcomes were sustained at 12 months post-randomisation.
  • The economic analysis indicated that CAP is likely to be cost-effective with regard to remission and also non-drinking outcomes.
     

I used to spend a lot of money on drink every month. But now all that money is getting saved; in last two months I have saved Rs. 5,000 to 6,000, which I would have spent on drinks. With the help of the counsellor, I have stopped drinking completely since last 2 months. After work, I used to go directly to the bar but now I go directly home and pray to god. Now I spend my evenings in the library and playing with my kids.” 

 

-(Male, harmful drinker, 30 years)

Innovation details

The framework for the development of Counselling for Alcohol Problems (CAP) was informed by a synthesis of existing evidence for cultural adaption of psychological treatments for mental health conditions, those that could be delivered by lay health workers as well as methodologies used by other Indian research teams for mental health intervention development.

Based on these experiences, our methodology6 involved 3 sequential stages:

  1. Identifying potential treatment strategies and developing a theoretical framework for the treatment
  2. Evaluating the acceptability and feasibility of the treatment
  3. Evaluating the effectiveness and cost-effectiveness of the treatment

Selecting feasible and acceptable strategies and developing a theoretical framework

  • Stage 1: A survey was conducted with 2 diverse groups to identify and filter pre-determined strategies deemed feasible and appropriate for delivery by lay counsellors and acceptable by patients within the Indian primary health care context.
  • Stage 2: Invited Local and international mental health experts to participate in six treatment development workshops based on the survey. A coherent treatment delivery framework was developed culminating towards a treatment plan of up to four sessions6

Evaluating the acceptability and feasibility of the CAP treatment

  • A clinical case series was carried out where treatment was delivered in stages from professionals to lay counsellors (with supervision).
  • Lay counselors delivered CAP to patients in PHCs and were supervised in groups by local mental health professionals.
  • Participants were identified through screening of PHC attenders, referrals from GPs and psychiatrists or were self‐referred clients.
  • CAP was iteratively revised based on observations made continuously through the case series

Evaluating the effectiveness and cost-effectiveness of the CAP treatment

A randomised controlled trial was designed and implemented in 8 PHCs in Goa, India. Participants were screened using the AUDIT and the Patient Health Questionnaire (PHQ- 9) and recruited from PHCs. Trained health assistants, independent of the counsellors, screened patients using AUDIT and administered a baseline questionnaire to trial participants to collect sociodemographic information (eg age and marital status) and data for potential moderators of treatment effect. All outcome interviews were audio-taped (with permission), and the tapes were randomly selected (using a random selection strategy stratified by outcome assessor) for review by the supervisor for quality assurance.

  • Treatment Arm: In the CAP group, participants received EUC plus CAP which was delivered in three phases over a maximum of four sessions (each lasting approximately 30–45 min) at weekly to fortnightly intervals.
  • Control Arm: In the EUC group, usual care (consultation with the PHC physician) was enhanced by provision of the screening results to the PHC physician and provision of a contextualised version of the WHO Mental Health Gap Action Programme guidelines9 for harmful drinking, including when and where to refer patients for specialist care.

Partners

Funders

Evaluation methods

Outcomes

  • Primary outcomes in the RCT were remission (defined as an AUDIT score < 8) and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months.
  • Secondary outcomes in the RCT included psychological assessment (Patient Health Questionnaire – 9), suicidal behaviour, disability and functioning (WHO Disability Assessment Schedule), social indicators i.e. days unable to work, perpetration of intimate partner violence, resource use and costs of illness (Client Service Receipt Inventory - CSRI)

Quality & Supervision

Treatment fidelity and quality was measured  through treatment completion rates, CAP Therapy Quality Scale (TQS) scores from peer and expert ratings of audio recordings of sessions during weekly group supervision, and rating of therapy quality of a random selection of 10% of all sessions by an expert involved in the development of CAP.

Cost of implementation

  • The incremental cost per additional remission was $217 (95% CI 50–1073), with an 85% chance of being cost-effective in the study setting.
  • Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes

Impact details

Acceptability and Feasibility Study (Case Series):

  • 20 participants (out of 128) were selected and invited to take part in the clinical case series
  • Patients expressed satisfaction with the treatment and reported being pleased at their reduced drinking and the resultant positive impact on their life
  • Furthermore, they endorsed how the counseling helped them understand their drinking and its effect on their health and techniques that they learned to manage their drinking

Effectiveness (RCT):

Outcomes at three months

  • Out of 377 adult male participants recruited into the RCT, 336 (89%) completed the 3 month primary outcome assessment (164 [87%] in the EUC plus CAP group and 172 [91%] in the EUC alone group).
  • 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) was also significantly higher in the CAP plus EUC arm than in the EUC alone arm.
  • There was no significant effect on mean daily alcohol consumed in the past 14 days among those who reported drinking in this period (37·0 g [SD 44·2] vs 31·0 g [27·8]; count ratio 1·08 [0·79–1·49]; p=0·62)

Outcomes at 12 months

  • 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)
  • 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)
  • The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]).

References

  1. Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJL, Vos T (2013) Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet 382:1575–86. [PubMed]​
  2. Pillai P, Nayak MB, Greenfield TK, Bond JC, Hasin DS, Patel V (2014) Adolescent drinking onset and its adult consequences among men: a population based study from India. J Epidemiol Community Health 68:922–927. [PubMed]​
  3. Gururaj G, Varghese M, Benegal V, Rao GN, Pathak K, Singh LK, et al. National Mental Health Survey of India, 2015–16: summary. Bengaluru: National Institute of Mental Health and Neurosciences; 2016
  4. Patel V, Parikh R, Nandraj S, et al. Assuring health coverage for all in India. Lancet 386: 2422–35.
  5. Knapp, M, et al. "Economic barriers to better mental health practice and policy." Health policy and planning 21.3 (2006): 157-170.​
  6. Nadkarni A, Velleman R, Dabholkar H, Shinde S, Bhat B, McCambridge J, Murthy P, Wilson T, Weobong B, Patel V. 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. Alcoholism: Clinical and Experimental Research. 2015 Mar;39(3):522-31.

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