Step Away from Depression-Study protocol for a multicenter randomized clinical trial for a pedometer intervention during and after in-patient treatment of depression.

OBJECTIVES Increasing the number of daily steps by using a pedometer and a diary leads to an activity increase and improved health outcomes in a variety of somatic disorders. Hence, for the inpatient treatment of depression, supervised exercise interventions are more widespread. We aim to examine if a self-managed pedometer intervention (PI) with the option of being proceeded after discharge leads to reduction of depression and to a physical activity (PA) increase. METHODS The Step Away from Depression (SAD) study is a multicenter randomized controlled trial targeting 400 patients with major depressive disorder. Treatment as usual (TAU) is compared to TAU plus PI after 4 weeks, at discharge, and 6 months after hospital admission. Primary outcomes are clinically rated depression severity and accelerometer-measured step counts. Secondary outcomes include self-reported depression symptoms and PA level, psychiatric symptoms, health-related quality of life, self-efficacy, and components of the Motivation Volition Process Model. RESULTS We report the design of the SAD study considering several methodological aspects for exercise studies, in general. CONCLUSIONS Results of our study will provide information about efficacy of PI for inpatient treatment and about interrelating processes of change concerning depression, PA, and aspects of motivation and volition.