Ell 2008.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Specialist Diagnosis: One of the two cardinal depression symptoms more than half of the days to nearly every day plus a PHQ‐9 depression scale score of greater than or equal to 10 indicating major depression and/or two questions from the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition indicating dysthymia Inclusion criteria: Low income, greater than or equal to 90 days after cancer diagnosis and receiving acute or follow‐up care in oncology clinics, 18 years or older Exclusion criteria: Acute suicidal ideation, advanced cancer or other condition that limited remaining life expectancy to less than 6 months, a score of 8 or greater on the Alcohol Use Disorders Identification Test alcohol assessment, recently used lithium/antipsychotic medication, a self‐reported adaptation of the Karnofsky Performance Status Scale score of 2 or less on an 11‐point scale representing severe functional impairment in cancer patients and inability to speak English or Spanish Age: 49.4% ≥ 50 years Gender: 84% female Ethnicity: 88% Hispanic Country: United States Sample size (randomised): Total participants 472, intervention 242, control 230 |
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| Interventions | Treatment: Alleviating Depression Among Patients with Cancer (ADAPt‐C) Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Oncologist (PCP), social workers (CM), psychiatrist (MH specialist) 2) a structured management plan: A stepped care algorithm (based on IMPACT) in which patients were randomised to AD or PST or combined. The algorithm included CMs who provided psychotherapy and community services navigation (with assistance from patient navigators) through a personalised treatment plan that included patient AD or PST preferences, stepped care management and protocol for PST and CM telephone maintenance/relapse prevention 3) scheduled patient follow‐ups: PST= 6‐12 weekly sessions, ADs = had as required appointments with psychiatrist. In maintenance CM telephoned patients monthly for up to 12 months post‐treatment initiation. 4) enhanced inter‐professional communication: The CM communicates with the PCP as needed and interacts via written notes or verbally. PCP provides maintenance prescriptions in consultation with MH specialist. MH specialist provides weekly telephone supervision to review the CMs caseload Control: Treatment as usual enhanced by patient/family depression and cancer educational pamphlets and a listing of centre/community financial, social services, transportation, and childcare resources. The treating PCP was informed of patients depression status |
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| Outcomes | Depression (PHQ‐9): 6, 12, 18, 24 months Medication use: 12, 18, 24 months Quality of Life (mental and physical health): 6, 12, 18, 24 months Satisfaction: 18, 24 months |
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| Notes | AD: antidepressant; CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire–9; PST: problem solving therapy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Low risk | Patients chose one of five sealed envelopes |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9, 50% reduction) was: overall 154/472 (33%), 76/242 (31%) intervention and 78/230 (34%) control. Reasons for loss to follow‐up provided, similar reasons for missing data across groups. Intention‐to‐treat analysis reported using available data and they also conducted analyses using multiple imputation methods |
| Selective reporting (reporting bias) | Low risk | Protocol available and all prespecified outcomes reported |
| 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 |