Richards 2008a.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Diagnosed as depressed by a General Practitioner, confirmed by a score of ≥ 5 on the depression section of the Standard Clinical Interview for DSM‐IV (SCID) Inclusion criteria: Patients aged over 18 with a newly identified episode of major depression, defined as a current episode of GP‐initiated treatment of not more than 1 months duration Exclusion criteria: Postnatal, bereavement or physical causes for depression, active suicidal plans and primary drug or alcohol dependence Age: Mean 42.2 years Gender: 78% female Ethnicity: 85% white Country: United Kingdom Sample size (randomised): Total clusters 24, intervention 12, control 12; Total participants 76, intervention 41, control 35 |
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| Interventions | Intervention: Collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: General practitioner (PCP), primary care MH workers (CM), psychiatrist/psychological therapist (MH specialist) 2) a structured management plan: Structured management plan of medication support and behavioural activation 3) scheduled patient follow‐ups: 10 in 3 months (initial face‐to‐face then weekly for 5 weeks, then fortnightly predominantly telephone calls) 4) enhanced inter‐professional communication: Three levels of communication: Level 1: treatment plan entered into medical record and brief record after each contact where patient was progressing/engaging satisfactorily, Level 2: CMs informed PCPs of changes to treatment plan by specific note, Level 3: CMs communicated in‐person or by telephone with PCP for urgent issues. CMs had weekly telephone supervision with MH specialists Control: Treatment as usual |
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| Outcomes | Depression (PHQ‐9): 3 months Quality of Life (mental and physical health): 3 months |
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| Notes | CM: case manager; DSM‐IV: Diagnostic and Statistical Manual fourth edition; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | Clusters (PCP practice) were centrally allocated by independent service. PCPs were not informed of their allocated group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9) was: overall 14/76 (18%), 6/41 (15%) intervention and 8/35 (23%) 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 | Low risk | The study appears free of other sources of bias |
| Implementation Integrity | Unclear risk | Insufficient information available to assess |
| 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 |