Smit 2006c.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Current Diagnostic and Statistical Manual (DSM‐IV) diagnosis of major depressive disorder, according to the primary care physician and confirmed by an independent structured psychiatric interview (Composite International Diagnostic Interview version 2.0) Inclusion criteria: Aged 18 ‐ 70 years Exclusion criteria: Patients suffering from a life threatening medical condition, a psychotic disorder, dementia, alcohol addiction or drug abuse, women who were pregnant or nursing, and patients already receiving mental health treatment elsewhere Age: Mean 43.5 years Gender: 59.5% female Ethnicity: Not stated Country: The Netherlands Sample size (randomised: Depression recurrence programme plus CBT): Total participants 116, intervention 44, control 72 |
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| Interventions | Intervention: Depression recurrence programme (DRP) plus CBT Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), MH nurse (CM), psychiatrist (MH specialist) 2) a structured management plan: Depression recurrence programme consisted of structured/standardised psychoeducational sessions including medication management, self‐care, relapse prevention and support. Patients received a book and videotape about depression, treatment options, relapse prevention and self‐management strategies. Face‐to‐face contact provided overview of programme and collaboration between CM and PCP, personal and medication history, stress reduction techniques, preparation of a recurrence prevention plan, encouraging socialising and scheduling pleasant activities. Telephone contacts included symptom monitoring and changes in recurrence prevention plan and/or medication. CBT provided after DRP involved 1‐hour sessions with a CBT therapist 3) scheduled patient follow‐ups: 3 face‐to‐face (2‐4 weekly) and 4 telephone contacts (2.5 months after last face‐to‐face session then every 3 months for 3 years) plus 10‐12 face‐to‐face CBT sessions (10‐12 weekly) 4) enhanced inter‐professional communication: CMs sent written feedback to PCP after each face‐to‐face contact and as needed. CMs also sent PCPs a copy of the recurrence prevention plan and accompanying letter. CMs received regular supervision from MH specialist. At end of CBT the therapist informed CM of content and progress made Control: Treatment as usual |
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| Outcomes | Depression (DSM‐IV recovered): 27 weeks Medication use: 3, 6, 9, 12, 36 months Quality of Life (mental and physical health): 36 months Satisfaction: 3 months |
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| Notes | CBT: cognitive behaviour therapy; CM: case manager; 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 |
| Allocation concealment (selection bias) | Low risk | Centrally by telephone by an individual not involved in patient recruitment, who opened a sealed opaque envelope |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (Recovered DSM‐IV) was: overall 18/116 (16%), 8/44 (18%) intervention and 10/72 (14%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. Used intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information available to assess |
| Other bias | Unclear risk | Insufficient information available to assess |
| 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 | High risk | Assessor was potentially aware of treatment allocation |