Katon 1999.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Diagnosis of depression or anxiety and patients at high risk for persistent depression. The first‐stage screen included the telephone Structured Clinical Interview for DSM‐III‐R (SCID). Criteria for selection for the second‐stage interview were having 4 or more residual major depressive symptoms, recurrent depression (2 or more prior episodes), or dysthymia. Four or more major depressive symptoms on the SCID and a score of 1.0 or greater on the 20 depression items of the Hopkins Symptom Checklist (HSCL‐20) or having fewer than 4 DSM‐IV major depressive symptoms but with a score of 1.5 or greater on the HSCL‐20.16 Inclusion criteria: Patients between the ages of 18 and 80 years who received a new antidepressant prescription (no prior prescriptions within the last 120 days) from a primary care physician Exclusion criteria: A screening score of 2 or more on the CAGE alcohol screening questionnaire, being pregnant or currently nursing, planning to pull out from the Group Health Cooperative insurance plan within the next 12 months, currently seeing a psychiatrist, having limited command of English, and recently using lithium or antipsychotic medication. Age: Mean 47 (SD 13.7) years Gender: 75% female Ethnicity: 80% White Country: United States Sample size (randomised): Total participants 228, intervention 114, control 114 |
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| Interventions | Intervention: Stepped collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), psychiatrist (CM/MH specialist) 2) a structured management plan: All patients were prescribed an AD 8‐9 weeks before initial intervention visit in which CM assessed clinical status and current medication adherence and side effects. CM helped the patient and PCP alter AD medication and monitored medication adherence by checking automated pharmacy data and alerted the PCP if premature discontinuation occurred. CMs also referred patients with severe psychosocial stressors for psychotherapy or support groups. 3) scheduled patient follow‐ups: 2 in 4 weeks with 2 additional if non‐response with a brief telephone call in between (2 calls in total) 4) enhanced inter‐professional communication: CM informed PCP of non‐adherence. After final visit, the CM sent PCP a standardised note of the AD prescribed, recommended duration of treatment, residual depressive symptoms and recommendations for therapy Control: Treatment as usual |
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| Outcomes | Depression (SCID): 3, 6 months Medication use: 1, 3, 6 months Quality of Life (mental and physical health): 1, 3, 6 months Satisfaction: 3, 6 months |
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| Notes | AD: antidepressant; 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 in blocks of 8 |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information available to assess |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (Asymptomatic by SCID) was: overall 36/228(16%), 18/114(16%) intervention and 18/114(16%) 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 | 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 |