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Open Access Study protocol

Cost-effectiveness of nurse-led self-help for recurrent depression in the primary care setting: design of a pragmatic randomised controlled trial

Karolien EM Biesheuvel-Leliefeld1*, Sandra MA Kersten1, Henriette E van der Horst1, Anneke van Schaik2, Claudi LH Bockting3, Judith E Bosmans4, Filip Smit56 and Harm WJ van Marwijk1

Author Affiliations

1 Department of General Practice and the EMGO + Institute for Health and Care Research (EMGO+), VU University medical Centre, Amsterdam, The Netherlands

2 Department of Psychiatry and the EMGO + Institute for Health and Care Research (EMGO+), VU University Medical Centre, Amsterdam, The Netherlands

3 Department of Clinical Psychology, Groningen University, Groningen, The Netherlands

4 Department of Health Sciences and EMGO + Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands

5 Department of Public Mental Health, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, The Netherlands

6 Department of Epidemiology and Biostatistics, EMGO + Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands

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BMC Psychiatry 2012, 12:59  doi:10.1186/1471-244X-12-59

Published: 7 June 2012

Abstract

Background

Major Depressive Disorder is a leading cause of disability, tends to run a recurrent course and is associated with substantial economic costs due to increased healthcare utilization and productivity losses. Interventions aimed at the prevention of recurrences may reduce patients' suffering and costs. Besides antidepressants, several psychological treatments such as preventive cognitive therapy (PCT) are effective in the prevention of recurrences of depression. Yet, many patients find long-term use of antidepressants unattractive, do not want to engage in therapy sessions and in the primary care setting psychologists are often not available. Therefore, it is important to study whether PCT can be used in a nurse-led self-help format in primary care. This study sets out to test the hypothesis that usual care plus nurse-led self-help for recurrent depression in primary care is feasible, acceptable and cost-effective compared to usual care only.

Design

Patients are randomly assigned to ‘nurse-led self-help treatment plus usual care’ (134 participants) or ‘usual care’ (134 participants). Randomisation is stratified according to the number of previous episodes (2 or 3 previous episodes versus 4 or more). The primary clinical outcome is the cumulative recurrence rate of depression meeting DSM-IV criteria as assessed by the Structured-Clinical-Interview-for-DSM-IV- disorders at one year after completion of the intervention. Secondary clinical outcomes are quality of life, severity of depressive symptoms, co-morbid psychopathology and self-efficacy. As putative effect-moderators, demographic characteristics, number of previous episodes, type of treatment during previous episodes, age of onset, self-efficacy and symptoms of pain and fatigue are assessed. Cumulative recurrence rate ratios are obtained under a Poisson regression model. Number-needed-to-be-treated is calculated as the inverse of the risk-difference. The economic evaluation is conducted from a societal perspective, both as a cost-effectiveness analysis (costs per depression free survival year) and as a cost-utility analysis (costs per quality adjusted life-year).

Discussion

The purpose of this paper is to outline the rationale and design of a nurse-led, cognitive therapy based self-help aimed at preventing recurrence of depression in a primary care setting. Only few studies have focused on psychological self-help interventions aimed at the prevention of recurrences in primary care patients.

Trial registration

NTR3001 (http://www.trialregister.nl webcite)

Keywords:
Major depressive disorder; relapse; recurrence; prevention; cognitive therapy; primary care; randomised controlled trial; design