Nadkarni 2019.

Study characteristics
Methods	Study design: RCT; single‐blind (outcome assessors), parallel‐arm   Duration of study: October 2013 to August 2016
Participants	Country: India  Income classification: lower‐middle income   Geographical scope: urban  Healthcare setting: 10 primary health centres  Mental health condition: alcohol dependence  Population 1. Age: 18 to 65 years  2. Gender: male  3. Socioeconomic background: more than 80% of participants were employed   4. Inclusion criteria (including threshold cutoff score of measurement tool)  a. Attendees at primary health centres b. 18‐ to 65‐year‐old males c. Residing in the PHC catchment area d. Intending to reside at the same address for at least 12 months e. Able to communicate clearly f. Able to comprehend one of the programme’s 4 languages g. Scoring ≥ 20 on the AUDIT    5. Exclusion criteria  a. Presenting with an emergency medical condition
Interventions	Stated purpose: to examine the feasibility of identifying and recruiting men with probable AD in primary care and of delivering a brief treatment for AD by lay counsellors in primary care, as well as acceptability and safety of treatment and preliminary cost‐effectiveness of treatment  INTERVENTION (n = 59)   Name: Counselling for Alcohol Problems (CAP)  Delivered by: LHW Title/name of PW and number: lay counsellors ‐ 11    1. Selection: no professional training in mental health, fluent in vernacular languages used in study settings. Applicants first needed to pass an interview involving role‐plays, then had to undergo a 2‐week classroom training and pass the competency assessment, then had to complete a 6‐month internship followed by a multiple choice examination and a skills test involving role‐plays with standardised vignettes and quality ratings of actual CAP sessions delivered  2. Educational background: completed at least high school    3. Training (contents, duration, by whom): intensive 2‐week classroom training and 6‐month internship with supervision of cases by experts, by 5 local specialists previously trained by international experts and who continued to receive once‐monthly supervision via Skype. Manuals available online    4. Supervision: weekly peer‐led supervision and twice‐monthly individual supervision by peers and experts  Intervention details: lay counsellors delivered CAP   1. Duration/frequency: maximum of four 30‐ to 45‐minute sessions at weekly to fortnightly intervals  2. Content of intervention (by types of health workers and per patients/carers): manualised psychological treatment involving detailed assessment, personalised feedback, helping patients to develop cognitive and behavioural skills and techniques, and learning how to manage potential or actual relapses using the skills acquired   CONTROL: enhanced usual care (n = 62) Comprised consultation with physician, providing screening results, and referral to a de‐addiction centre (options included outpatient and inpatient settings, public hospitals, and private rehabilitation centres)   CO‐INTERVENTIONS: patients in intervention group also had enhanced usual care: consultation with physician, providing screening results, and referral to a local de‐addiction centre
Outcomes	Patients  1. Remission defined as AUDIT score < 8*  2. Mean daily ethanol consumption (g) in past 14 days*  3. Percentage of days abstinent (PDA)  4. Percentage of days of heavy drinking (PDHD)  5. Recovery defined as AUDIT < 8 at both 3 and 12 months  6. PHQ‐9  7. Short inventory of problems  8. WHO‐DAS score  9. Total days unable to work  10. Perpetration of intimate partner violence  11. Unplanned hospitalisation in past 12 months  12. Death due to any cause in past 12 months  13. Suicidal behaviour 14. Uptake of detoxification services#  Carers  Nil  Process/health workers 1. Acceptability and feasibility indicators – number of sessions# 2. Duration of sessions#  3. Homework completion# 4. Significant other involvement#  5. Planned discharge# 6. Referrals#  Economic outcomes  1. Doctor consultations  2. Detoxification service costs  3. Admissions 4. Laboratory tests 5. Medicines 6. Total health service utilisation costs 7. CAP treatment 8. Time costs to service users and families 9. Productivity losses 10. Total costs from health system perspective 11. Total costs from societal perspective (Table 6)  (asterisk for study's primary outcomes; star: outcomes that we have not reported in this review)  Time points post intervention: 1 to 2 months, 10 to 11 months
Notes	Source of funding: Wellcome Trust Senior Research Fellowship grant  Notes on validation of instruments (screening and outcomes): validated  Additional information (e.g. provided by authors, existence of a published study protocol): selection and training of lay counsellors described in  Nadkarni A; Weobong B; Weiss HA; McCambridge J; Bhat B, et al. Counselling for Alcohol Problems (CAP), a lay counsellor‐delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial. Lancet 2017;389(10065):186‐95. Declarations of interest ‐ none Handling the data (e.g. imputed values, other calculations we have made): nil  Prospective trial registration number: ISRCTN76465238
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation list in randomly sized blocks (2 to 4), stratified by PHC, was generated by a statistician independent of the trial
Allocation concealment (selection bias)	Low risk	Randomisation code was concealed and consenting participants were randomised at the individual level by trained health assistants based at primary health centres in a 1:1 allocation scheme to either of 1 intervention arms (enhanced usual care (EUC) or EUC plus CAP) after completion of baseline assessments, using sequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Physicians providing EUC were masked to allocation status. Participants and interventionists in experimental arm were not blinded, but this is unlikely to have influenced outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Assessors who performed outcome assessments were blinded to participants' allocation status. All study authors, apart from the data manager (B.B.), were masked
Baseline outcome measurements similar	Low risk	See Table 1
Baseline characteristics similar?	Low risk	Baseline characteristics were similar and are reported in Table 1
Incomplete outcome data (attrition bias) Efficacy data	Low risk	Attrition rates are similar between groups. A total 112 participants at 12‐month follow‐up: 58 (11 missing) in the intervention group vs 54 (14 missing) in the control group
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Low risk	Attrition is similar between treatment and control groups
Protection against contamination	Low risk	Reasonable protection against contamination
Selective reporting (reporting bias)	Low risk	All primary outcomes planned in published clinical trial protocol were reported. All planned secondary outcomes were reported, except change in marital status and in employment status (non‐clinical outcomes)
Other bias	Low risk	No other sources of bias were found