Abstract
BackgroundDepressive disorders are highly prevalent and result in negative consequences for both patients and society. It is therefore important that these disorders are treated adequately. However, due to increased demand for mental healthcare and subsequent increased costs, it would be desirable to reduce costs associated with major depressive disorder while maintaining or improving the quality of care within the healthcare system. Introducing evidence-based online self-help interventions in mental healthcare might be the way to maintain clinical effects while minimizing costs by reducing the number of face-to-face sessions. This study aims to evaluate the clinical and economical effects of a guided online self-help intervention when offered to patients with major depressive disorder on a waiting list for psychotherapy in specialized mental health centers (MHCs).MethodsPatients at mental health centers identified with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of major depression who are awaiting face-to-face treatment are studied in a randomized controlled trial. During this waiting list period, patients are randomized and either (1) receive an internet-based guided self-help treatment or (2) receive a self-help book. The 5-week internet-based guided self-help intervention and the self-help booklet are based on problem solving treatment. After the intervention, patients are allowed to start regular face-to-face treatment at MHCs. Costs and effects are measured at baseline, after the intervention at 6 to 8 weeks, 6 months and 12 months. The primary outcome measure is symptoms of depression. Secondary outcome measures are diagnosis of depression, number of face-to-face sessions, absence of work and healthcare uptake in general. Additional outcome measures are anxiety, insomnia, quality of life and mastery.DiscussionThis study evaluates the effectiveness and cost effectiveness of internet-based guided self-help in patients at specialized mental health centers. The aim is to demonstrate whether the introduction of internet-based self-help interventions in regular mental healthcare for depressive disorders can maintain clinical effects and reduce costs. Strengths and limitations of this study are discussed.Trial registrationNetherlands Trial Register NTR2824
Highlights
Depressive disorders are highly prevalent and result in negative consequences for both patients and society
AOCEQ ‘Alles Onder Controle’ Expectation Questionnaire, AOCSQ ‘Alles Onder Controle’ Satisfaction Questionnaire, CAGE ‘Cutting down, Annoyance by criticism, Guilty feeling, and Eye-openers’, Credibility/Expectancy Questionnaire of Devilly and Borkovec (CEQ) Credibility/Expectancy Questionnaire, CES-D Center for Epidemiological Studies Depression scale, Clinical International Diagnostic Interview (CIDI) Composite International Diagnostic Interview, CSQ-8 Client Satisfactory Questionnaire-8, EuroQol 5-Dimensions questionnaire (EQ-5D) EuroQol 5-Dimensions, F2F face-to-face, ISI Insomnia Severity Index, Hospital Anxiety and Depression Scale (HADS) Hospital Anxiety Depression Scale, mental health centers (MHCs) mental health center, NEO-FFI NEO-Five Factor Inventory, TiC-P Trimbos and iMTA Questionnaire on Costs Associated with Psychiatric Illness
This study will examine the effectiveness of offering an internet-based guided self-help intervention to patients before to start of face-to-face treatment in comparison with patients who have to wait for face-to-face treatment
Summary
Study design The study is a randomized controlled trial with an economic evaluation. We are currently enrolling 248 patients over 2 large mental health centers (MHCs) in 10 different locations. People on the waitlist will receive a self-help book without additional guidance in order to motivate them to participate in the randomize, controlled trial (RCT) Both groups are allowed to receive regular face-to-face (FTF) therapy at the MHCs after the waitlist period. Inclusion and exclusion criteria Eligible participants are adults, aged 18 or over, registering for regular treatment at one of the participating MHCs who meet the criteria for a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of major depression as measured with the Clinical International Diagnostic Interview (CIDI) by a trained research assistant, have access to the internet, and adequate proficiency in Dutch. Earlier research shows that self-help without any form of guidance only results in a small effect on participants with increased levels of depressive symptoms [16] Participants in both conditions will be referred for regular FTF treatment after registration at the MHC. The HADS has shown to be reliable in Dutch populations [21]
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