Patel 2010.

Study characteristics
Methods	Study design: RCT (cluster trial ‐ unit allocation ‐ health facility (PHC or GP), 12 clusters in each arm, 24 in total; analysis ‐ individual) Duration of study: April 2007 to September 2009
Participants	Country: India Income classification: lower‐middle income Geographical scope: urban and rural Healthcare setting: PC facilities, i.e. all facilities with space and privacy for LHCs; regular outpatient clinics not involved in preliminary phases of the project. There were government PHC facilities and private GP settings Mental health condition: common mental disorders Population: patients 1. Age: > 17 2. Gender: both 3. Socioeconomic background: predominantly female; married and one‐third widower; nearly half with < 1 year of education or illiterate 4. Inclusion criteria a. Adults > 17 years of age b. Speaking Konkani, Marathi, Hindi, English c. Not needing medical attention d. Did not have difficulty with hearing, speaking, cognition e. Not already screened in previous weeks f. Not receiving intervention g. Screened positive for common mental disorders with GHQ‐12 with previously validated cutoff > 5) h. Expected to be resident of Goa for subsequent 12 months 5. Exclusion criteria a. Cognitive or sensory impairment that made participation in evaluation difficult b. Not speaking Konkani, Marathi, Hindi, English
Interventions	Stated purpose: to test the effectiveness of an intervention led by LHCs in PC settings to improve outcomes of people with these disorders INTERVENTION (n = 1160) Name: collaborative stepped‐care intervention ‐ phase 1 (12 government PHCs) and phase 2 (12 private GP facilities) Delivered by: LHW and PHP Title/name of PW and number: LHCs (lay health counsellors); GP and PHC physicians 1. Selection: LHC: a woman fluent in local languages, with excellent communication skills, and available for consultations on a regular basis in the clinics; GP/PHC physician: those located at selected facilities 2. Educational background: LHC: graduates ‐ locally recruited, graduate non‐medical workers; GP/PHC physician: registered medical GP as per a priori eligibility criteria 3. Training: LHC: training component included how to deliver various treatments, including counselling skills, psychoeducation, yoga, and IPT. Training was based on a draft manual developed for the intervention. Duration: 2 months' training. Trained by research team. GP/PHC physician: half day of training and given a manual 4. Supervision: LHCs and GPs/PHC physicians: clinical specialist (psychiatrist) visited about once a month and was available for consultation on the telephone to discuss cases 5. Incentives/remuneration: not mentioned Intervention details 1. Duration/frequency: both phases carried out consecutively between April 2007 and September 2009 2. Content of intervention: LHCs provided psychoeducation: psychoeducation taught patients strategies to alleviate symptoms, such as breathing exercises for anxiety symptoms and scheduling activities for symptoms of depression. Encouraging adherence to treatments for these disorders and providing information about social and welfare organisations when needed were other key components of psychoeducation. Individual (not group) IPT was also provided by the LHC as the psychological treatment of choice. Focus on interpersonal problems such as grief, disputes, and role transitions. Minimum of 6 sessions, with an optimum of 8 and a maximum of 12 sessions, was offered to each eligible participant. Interpersonal psychotherapy was reserved for patients who had moderate or severe common mental disorders, and was offered as an alternative to, or in addition to, antidepressant drugs for those who did not respond to antidepressant treatment. Physician/GP roles: prescribe antidepressants according to a protocol for moderate to severe depression (private GPs could prescribe their drug of choice, PHC doctors had to use fluoxetine 20 to 40 mg/d). Other key roles of physicians were to encourage patients to meet the LHC, to avoid use of unnecessary drugs, and to provide usual care for any co‐existing physical health problems. Referral: Referral to the clinical specialist was reserved for patients who were assessed as having high suicide risk at any stage, were unresponsive to earlier treatments, posed diagnostic dilemmas, had substantial comorbidity with alcohol dependence, or had other associated substantial medical problems, or for whom the PC physician requested a consultation CONTROL (n = 1269) Enhanced usual care: physicians and patients in usual care practices received screening results and were given the treatment manual prepared for PC physicians. Physicians were allowed to start treatments of their choice CO‐INTERVENTIONS: none
Outcomes	Patients 1. Screening: GHQ‐12 2. Primary outcome: CIS‐R*: generates 2 outputs ‐ an ICD‐10 diagnosis derived from a computer algorithm and a total score indicating overall severity of symptoms Carers None Process/health workers None Economic outcomes None (*: primary outcomes of the study) Time points: baseline; follow‐up at 6 months, 12 months
Notes	Source of funding: MANAS project was funded by a Wellcome Trust fellowship in clinical sciences Notes on validation of instruments (screening and outcomes): validated GHQ in Goa setting but not specified for the CIS‐R Additional information (e.g. provided by authors, existence of a published study protocol): yes; declaration of interests ‐ all study authors’ expenses related to this trial were paid for by the Wellcome Trust grant through partner institutions. Study authors declared no other conflicts of interest Handling the data: as per footnotes in data and analysis Prospective trial registration number: NCT00446407
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote 1: "facilities were stratified into three strata: urban with a visiting psychiatrist (VP), rural with a VP, rural without a VP. Two intervention and two control PHCs were selected at random from each stratum, using on‐line software by the MANAS trial statistician (HW). A given seed number was used to enable the randomisation procedure to be reproduced. This guards against mis‐allocation or changes in allocation at a later stage" Quote 2: "for phase 1, 17 facilities in Goa met these inclusion criteria, of which 12 were randomly selected for inclusion in the trial. PHC facilities were first stratified by the presence or absence of a visiting psychiatrist and then randomised within four strata defined by size" Quote 3: "12 of the 22 eligible GP facilities were randomly selected for phase 2 of the trial. The 12 GP facilities were randomised within two strata defined by size. For both phases, facilities were randomly allocated within each stratum to either the intervention or control arm using a 1:1 allocation ratio using a computer‐generated randomisation sequence"
Allocation concealment (selection bias)	Low risk	Quote 1: "randomly allocating unique patient IDs [identification number] so that there is no association between the ID number and the facility identity" Quote 2: "assessing the efficacy of blinding (through asking assessors to guess which arm the participant is allocated to) at the end of the trial"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: this was a cluster‐randomised trial, but non‐blinding of participants was unlikely to affect outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Quote 1: "health assistant completes baseline CIS‐R schedule" Quote 2: "masking of the research assessor maximised by; undertaking assessment at home; randomly allocating clinic identification numbers to patients so that there was no association between their number and identity of the facility; outcome assessment by an independent association and undertaking primary outcome assessment before all assessment" Quote 3: "emphasizing to assessors that all patients are receiving an intervention (not specifying whether this is enhanced care or Collaborative Stepped Care) and that there is genuine equipoise about which is better. but also: health assistant completes baseline CIS‐R schedule"
Baseline outcome measurements similar	Low risk	Quote 1: "we recorded little intra‐cluster correlation (0.03), and the coefficient of variation (k) for prevalence of these disorders at baseline in all patients who screened positive was 0.08" Quote 2: "although participants in the enhanced usual care group were more likely to have depression, the proportion of patients with these disorders according to ICD‐10 and mean CIS‐R scores were similar"
Baseline characteristics similar?	Low risk	Quote 1: "characteristics of patients differed by clinic type" Quote 2: "distribution of these disorders between groups was similar; although participants in the enhanced usual care group were more likely to have depression, the proportion of patients with these disorders according to ICD‐10 and mean CISR scores were similar" Comment: baseline characteristics were dissimilar but were adjusted for in the analysis
Incomplete outcome data (attrition bias) Efficacy data	Unclear risk	Quote: "1160 participants (85%) in the collaborative stepped‐care group and 1269 (88%) in the control group completed the 6‐month outcome assessment" Comment: low risk at 6 months, but high risk at 12 months: significant difference in attrition between collaborative care and control groups (81% vs 77%; P = 0.01), which may not be clinically significant; nevertheless no reasons stated for this variation in dropout
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Low risk	Quote 1: "no stopping rules are proposed because serious adverse events are not expected in the trial since none of the treatments being offered are experimental or associated with serious outcomes" Quote 2: "there were seven serious adverse events (three deaths and four suicide attempts) in the collaborative stepped‐ care group and 12 in the enhanced usual care group (six deaths and six suicide attempts). None of the deaths were from suicide"
Protection against contamination	Low risk	Quote: "we do not anticipate a significant risk of contamination, i.e. patients moving from an Enhanced usual care control facility to an intervention facility, due to the geographical spread of facilities, and because no publicity will be produced regarding the availability of the intervention in other facilities"
Selective reporting (reporting bias)	Low risk	Comment: clinical trial protocol also stated disability outcomes, which were not reported in this paper. However, disability scores were used to generate QALY results (to calculate ICERs), which were reported in a separate paper (Buttorf 2012) that focused on economic outcomes
Other bias	Low risk	Comment: no other bias detected