The systematic activation method as a nursing intervention in depressed elderly: a protocol for a multi – centre cluster randomized trial

The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD.The study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60？years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d？=？0.7, we intend to include 51 participants per condition (n？=？102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life.To our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly population. This research has been approved by the medical research ethics committee for health-care settings in the Netherlands (No. NL26878.029.09) and is listed in the Dutch Trial Register (NTR No.1809).Depression in later life is a common mental disorder. Prevalence rates for depressive symptoms range between 3% and 35%, for minor depression approximately 10% [1], and for Major Depressive Disorder (MDD) 2% [2]. The prognosis of MDD in later life is poor: in three quarters of cases, the disorder becomes chronic [3]. MDD has serious consequences for everyday life (e.g. withdrawal from social activities, negl