Effects of a stepped-care intervention programme among older subjects who screened positive for depressive symptoms in general practice: the PROMODE randomised controlled trial.

Objectives: to determine (cost)-effectiveness of a stepped-care intervention programme among subjects ≥ 75 years who screened positive for depressive symptoms in general practice.
Design: the pragmatic cluster-randomised controlled trial with 12-month follow-up.
Setting: sixty-seven Dutch general practices.
Subjects: two hundred and thirty-nine subjects ≥ 75 years screened positive for untreated depressive symptoms (15-item Geriatric Depression Scale ≥ 5).
Methods: usual care (34 practices, 118 subjects) was compared with the stepped-care intervention (33 practices, 121 subjects) consisting of three steps: individual counselling; Coping with Depression course; and-if indicated-referral back to general practitioner to discuss further treatment. Measurements included severity of depressive symptoms [Montgomery-Åsberg Depression Rating Scale (MADRS)], quality of life, mortality and costs.
Results: at baseline subjects mostly were mildly/moderately depressed. At 6 months MADRS scores had improved more in the usual care than the intervention group (-2.9 versus -1.1 points, P=0.032), but not at 12 months (-3.1 versus -4.6, P=0.084). No significant differences were found within two separate age groups (75-79 years and ≥ 80 years). In intervention practices, 83% accepted referral to the stepped-care programme, and 19% accepted course participation. The control group appeared to have received more psychological care.
Conclusions: among older subjects who screened positive for depressive symptoms, an offered stepped-care intervention programme was not (cost)-effective compared with usual care, possibly due to a low uptake of the course offer.
Trial Registration: www.controlled-trials.com/ISRCTN 71142851v.