Optimization of measurement-based care (OMBC) for depression based on all-round and continuous assessment: rationale and protocol for a multicenter randomized control clinical trial

Abstract

BackgroundDespite the recent findings presenting the benefits of measurement-based care (MBC) compared to treatment as usual (TAU), MBC is still not the standard of care used in clinical settings. The aim of the present study was to achieve the optimization of MBC (OMBC) for major depressive disorder (MDD) by establishing a comprehensive MBC framework based on all-round, continuous assessment for depression.MethodsThe target recruitment size is 900 patients, and the study is conducted at 8 centers in China. The patients are randomly assigned to the MBC and TAU groups at a 2:1 ratio. The subjects are scheduled to remain for 12 weeks in the acute phase and for 12 months in the maintenance phase. The primary outcomes are the complete remission rate and the proportion of patients with a 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR 16) total score ≤ 5 of the MBC and TAU groups at the acute phase, and the recurrence rate/time between the two groups is measured at the maintenance phase. Secondary outcomes included the changes in the parameters QIDS-SR 16, Patient Health Questionnaire-9 (PHQ-9), and 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline and the response rate between the two groups at the acute phase as well as the comparison of recurrence rate between the two groups at the end of the study.Trial registrationChinese Clinical Trial Registry, ChiCTR-OOC-17012566. The registration was performed retrospectively on 4 September 2017.