Unutzer 2002.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Current major depression or dysthymic disorder according to the Structured Clinical Interview for DSM (SCID). Inclusion criteria: Age 60 years or older, plans to use one of the participating clinics as the main source of general medical care in the coming year, English speaking Exclusion criteria: Current drinking problems, history of bipolar disorder or Psychosis, ongoing treatment with a psychiatrist, severe cognitive impairment, acute risk for suicide and needing immediate care, lack of transportation or access to a telephone Age: Mean 71.2 (SD 7.5) years Gender: 65% female Ethnicity: 23% ethnic minority Country: United States Sample size (randomised): Total participants 1801, intervention 906, control 895 |
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| Interventions | Intervention: Improving Mood‐Promoting Access to Collaborative Treatment (IMPACT) Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), nurse/psychologist (CM), academic PCP/psychiatrist (MH specialist) 2) a structured management plan: CM educates using a brochure and a videotape attempting to form a therapeutic alliance and encouraging patient to become an active participant in depression care. CMs discuss treatment preferences (including ADs and psychotherapy), offers follow‐up for 1‐year period and coordinates depression care with patient’s PCP. CMs track clinical progress and monitor treatment side‐effects at each contact or delivers problem solving therapy (PST). A 3‐step treatment algorithm was developed allowing treatment team to establish a treatment plan for each patient’s need over time. Step 1: Start AD or PST. Non‐response becomes step 2: alternative AD or from AD to PST, or vice versa. Non‐response at step 2 is discussed and considered for psychiatric consultation and step 3: combination of treatments. Relapse prevention plans were developed when recovery achieved 3) scheduled patient follow‐ups: PST=6‐8 sessions. Acute phase CM contact=weekly or biweekly (telephone or face‐to‐face). Once symptoms in remission, follow‐up about once per month 4) enhanced inter‐professional communication: CM coordinates depression care with patient’s PCP and receives weekly supervision from MH specialist who also sees patients if necessary. Control: Treatment as usual enhanced as patients were informed of their diagnosis and encouraged to follow‐up with PCP |
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| Outcomes | Depression (HSCL‐20): 3, 6, 12, 18, 24 months Medication use: 3, 6, 12, 18, 24 months Quality of Life (mental and physical health): 3, 6, 12, 18, 24 months Satisfaction: 3, 6, 12, 18, 24 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 |
| Allocation concealment (selection bias) | Low risk | Centrally prepared numbered sealed envelopes, used sequentially |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL‐20 depression) was: overall 231/1801 (13%), 105/906 (12%) intervention and 126/895 (14%) 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 | 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 |