Asarnow 2005.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Either of 2 criteria: (1) endorsed “stem items” for major depression or dysthymia from the 12‐month Composite International Diagnostic Interview (CIDI‐12 [Core version 2.1]) modified slightly to conform to diagnostic criteria for adolescents, 1 week or more of past month depressive symptoms, and a total CES‐D score of 16 or greater (range of possible scores, 0‐60); or (2) a CES‐D score of 24 or greater Inclusion criteria: Aged 13 to 21 years and presenting at clinic for primary care visit Exclusion criteria: Having previously completed screening, not English‐speaking, clinician not in the study, and sibling already in the study. Age: Mean 17.2 (SD 2.1) years Gender: 78% female Ethnicity: 56% Hispanic/Latino Country: United States Sample size (randomised): Total participants 418, intervention 211, control 207 |
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| Interventions | Treatment: Quality improvement intervention Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: PCP, psychotherapists with MH nursing or nursing backgrounds (CM), study team (MH specialist) 2) a structured management plan: (1) expert leader teams at each site adapted and implemented the intervention; (2) CMs supported PCPs with patient evaluation, education, medication and psychosocial treatment, and linkage with specialty MH services; (3) trained CMs delivered manualised CBT; and (4) patient and clinician choice of treatments (CBT, medication, combined CBT and medication, care manager follow‐up, or referral). The CBT manual included a session introducing the treatment model, three 4‐session modules emphasising different CBT components (activities/social skills, cognition, and communication/problem solving), and a final session emphasising relapse prevention. The Texas Medication Algorithms for MDD guided medication treatment and emphasised SSRI's as the first‐stage medication choice 3) scheduled patient follow‐ups: 1 x 45 session with CM and 1 x 15 minute with PCP then a) medication or medication and psychotherapy (follow‐up visits and/or telephone calls by CM and/or PCP) b) psychotherapy (CBT initiated and PCP and/or CM follow‐up arranged) c) no treatment (CM follow‐up). CBT = 14 weekly sessions, CMs followed up with patients during the 6‐month intervention period 4) enhanced inter‐professional communication: CMs supported PCPs with patient evaluation, education, medication and psychosocial treatment, and linkage with specialty mental health service. Regular consultation from study team to support fidelity to the treatment model and provide case‐specific training in CBT and patient outreach/engagement strategies. Control: Treatment as usual enhanced by providing PCPs with training and educational materials (manuals, pocket cards) on depression evaluation and treatment |
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| Outcomes | Depression (CES‐D): 6, 12, 18 months Medication use: 6, 12 and 18 months Quality of Life (physical and mental health): 6, 12, 18 months Satisfaction: 6, 12, 18 months |
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| Notes | CBT: cognitive behaviour therapy; CES‐D: Centre for Epidemiological Studies Depression; CIDI: Composite International Diagnostic Interview; CM: case manager; MDD: major depressive disorder; MH: mental health; PCP: primary care provider; SSRI: selective serotonin reuptake inhibitor | |
| 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 by an individual not involved in patient recruitment after a time delay (median, 21 days) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (CES‐D) was: overall 74/418 (18%), 41/211 (19%) intervention and 33/207 (16%) control. Reasons for loss to follow‐up provided, with similar reasons for missing data 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 | Low risk | Assessor was not aware of treatment allocation |