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the systematic activation method as a nursing intervention in depressed elderly a protocol for a multi – centre cluster randomized trial系统的激活方法作为抑郁的老年护理干预协议多中心集群随机试验
Clignet et al. BMC Psychiatry 2012, 12:144
/1471-244X/12/144
STUDY PROTOCOL Open Access
The systematic activation method as a nursing
intervention in depressed elderly: a protocol for a
multi – centre cluster randomized trial
Frans Clignet1,2,3,4*, Berno van Meijel1,4,5, Annemiek van Straten1,2,6 and Pim Cuijpers1,2
Abstract
Background: Depression in later life is a common mental disorder with a prevalence rate of between 3% and 35%
for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment
modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation
(BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy
accessible intervention for both patients and health care workers (such as nurses), there is no research on the
effectiveness of the intervention in inpatient depressed elderly.
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.
Methods/design: 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
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