Simon 2004a.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Depression assessed by Hopkins Symptom Checklist Depression Scale (HSCL) and Patient Health Questionnaire (PHQ). Those already in remission at the baseline assessment (i.e. HSCL depression score < 0.5) were excluded Inclusion criteria: Primary care patients beginning antidepressant treatment for depression Exclusion criteria: Receiving psychotherapy, those already in remission when contacted, diagnosis of bipolar or schizophrenia in the last 2 years, cognitive, language, or hearing impairment severe enough to preclude participation Age: Mean 44.5 years Gender: 75% female Ethnicity: 80% white Country: United States Sample size (randomised): Total participants 402, intervention 207, control 195 |
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| Interventions | Intervention: Telephone care management Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), MH clinician (CM), psychologist/psychiatrist (MH specialist) 2) a structured management plan: Using scripts and motivational enhancement techniques each CM telephone call included a brief, structured assessment of depressive symptoms, AD use, and adverse effects. CMs also provided crisis intervention and referral to mental health specialty care when necessary. Patients received a detailed self‐management workbook emphasising behavioural activation, identifying and challenging negative thoughts, and developing a long‐term self‐care plan. CMs recommended reading the workbook but did not provide any specific counselling 3) scheduled patient follow‐ups: 3 telephone contacts (weeks 4, 8 and 16) and 2 written mailings (weeks 26 and 36) 4) enhanced inter‐professional communication: CMs sent PCPs a structured report of each contact including a summary of clinical progress and computer‐generated recommendations regarding medication adjustment. If a change in treatment was recommended, the CM contacted the PCP to facilitate patient‐physician communication and follow‐up. CMs received weekly supervision from MH specialists Control: Treatment as usual |
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| Outcomes | Depression (HSCL): 6 weeks, 3, 6, 9, 12, 15, 18 months Medication use: 6 months Satisfaction: 3, 6 months |
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| Notes | CM: case manager; HSCL: Hopkins Symptom Checklist; 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 | Allocation conducted centrally by an individual not involved in patient recruitment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL 50% improvement) was: overall 42/402 (10%), 23/207 (11%) intervention and 19/195 (10%) control. Reasons for loss to follow‐up not provided. 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 | 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 |