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 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. DISCUSSION: 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).
Abstract Background Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years, primarily due to physical comorbidity linked to cardiometabolic risks that are mainly driven by unhealthy lifestyle behaviours. To improve physical health in clients with SMI, key elements are systematic somatic screening and lifestyle promotion. The nurse-led GILL eHealth was developed for somatic screening and the imple‑ mentation of lifestyle activities in clients with SMI. Aims of this study are to evaluate the efectiveness of the GILL eHealth intervention in clients with SMI compared to usual care, and to evaluate the implementation process, and the experiences of clients and healthcare providers with GILL eHealth. Methods The GILL study encompasses a cluster-randomised controlled trial in approximately 20 mental health care facilities in the Netherlands. The randomisation takes place at the team level, assigning clients to the eHealth inter‑ vention or the usual care group. The GILL eHealth intervention consists of two complementary modules for somatic screening and lifestyle promotion, resulting in personalised somatic treatment and lifestyle plans. Trained mental health nurses and nurse practitioners will implement the intervention within the multidisciplinary treatment context, and will guide and support the participants in promoting their physical health, including cardiometabolic risk management. Usual care includes treatment as currently delivered, with national guidelines as frame of reference. We aim to include 258 clients with SMI and a BMI of 27 or higher. Primary outcome is the metabolic syndrome severity score. Secondary outcomes are physical health measurements and participants’ reports on physical activity, perceived lifestyle behaviours, quality of life, recovery, psychosocial functioning, and health-related self-efcacy. Measurements will be completed at baseline and at 6 and 12 months. A qualitative process evaluation will be conducted alongside, to evaluate the process of implementation and the experiences of clients and healthcare professionals with GILL eHealth. Discussion The GILL eHealth intervention is expected to be more efective than usual care in improving physical health and lifestyle behaviours among clients with SMI. It will also provide important information on implementation of GILL eHealth in mental health care. If proven efective, GILL eHealth ofers a clinically useful tool to improve physical health and lifestyle behaviours.
