Patel 2010.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Common mental disorder assessed using a score of over 5 on the General Health Questionnaire (GHQ) Inclusion criteria: Age >17 years, not requiring urgent medical attention, not already screened in the previous 2 weeks; and not already receiving the intervention. Those who fulfil the following criteria also invited to participate in the outcome evaluation of the trial: resident in Goa for the subsequent 12 months; speak one of the three primary study languages (Konkani, Marathi, English) Exclusion criteria: Do not suffer from a serious impairment (hearing, speech, cognition) which interferes with participation in an interview Age: Mean 46.3 (SD 13.3) years Gender: 83% female Ethnicity: 96% Indian Country: India Sample size (randomised): Total clusters 24, intervention 12, control 12; Total participants 2796, intervention 1360, control 1436 |
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| Interventions | Intervention: Collaborative stepped care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Physician/General Practitioners (PCP), lay health counsellor (CM), psychiatrist (MH specialist) 2) a structured management plan: Step 1: Psychoeducation including strategies to alleviate symptoms, e.g. breathing exercises for anxiety and scheduling activities for depression. Step 2: Management of moderate or severe cases included ADs or interpersonal psychotherapy (IPT) and adherence was encouraged and information provided on social/welfare organisations when needed. Step 3: Non‐response patients offered AD and IPT and adherence management. Step 4: Continue existing treatments and refer to clinical specialist 3) scheduled patient follow‐ups: IPT: minimum of 6 sessions, with an optimum of 8 and maximum of 12 4) enhanced inter‐professional communication: CM collaborated closely with PCP and MH specialist, PCP could request a patient consultation with the MH specialist if necessary. MH specialists visited the practice once a month and were available for telephone consultation Control: Treatment as usual enhanced as PCP received screening results and were given the treatment manual that provided information about commonly available drugs and their side‐effects and costs |
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| Outcomes | Depression (ICD‐10 recovery): 2, 6, 12 months | |
| Notes | AD: antidepressant; CM: case manager; IPT: interpersonal psychotherapy treatment; MH: mental health; PCP: primary care provider | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated cluster randomisation |
| Allocation concealment (selection bias) | Unclear risk | Clinics were centrally allocated by an individual not involved in recruitment, those involved in patient recruitment may have been aware of clinic allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (ICD10 recovery) was: overall 281/2242 (13%), 154/1098 (14%) intervention and 127/1144 (11%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. Used intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | Protocol available and all prespecified outcomes reported |
| Other bias | Unclear risk | Insufficient information available to assess |
| Implementation Integrity | Low risk | Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor was not aware of treatment allocation |