Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression

BMC Psychiatry

Study Protocol

Javier de Diego-Adeliño¹  Víctor Pérez²  Azucena Justicia²  Ana Isabel Cebria³  Diego J. Palao³  Dolors Puigdemont⁴  Matilde Elices⁵  Jesús Gorosabel⁶  Andrea Gabilondo⁷  Alvaro Iruin⁷  Ulrich Hegerl⁸ 

[1] Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain;Departament de Psiquiatria i Medicina Legal, Universitat Autònoma de Barcelona, Barcelona, Cerdanyola del Vallès, Spain;Departament de Psiquiatria, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau, Barcelona, Spain;Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain;Departament de Psiquiatria i Medicina Legal, Universitat Autònoma de Barcelona, Barcelona, Cerdanyola del Vallès, Spain;Institut de Neuropsiquiatria i Addiccions (INAD), PSMar, Barcelona, Spain;Institut Hospital del Mar d’Investigacions Mèdiques (IMIM), Barcelona, Spain;Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain;Departament de Psiquiatria i Medicina Legal, Universitat Autònoma de Barcelona, Barcelona, Cerdanyola del Vallès, Spain;Parc Taulí Hospital Universitari, Sabadell, Spain;Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain;Departament de Psiquiatria, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau, Barcelona, Spain;Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain;Institut Hospital del Mar d’Investigacions Mèdiques (IMIM), Barcelona, Spain;Centro de Salud Lagasca, Madrid, Spain;Outpatient Mental Health Care Network, Osakidetza- Basque Health System, Biodonosti Health Research Institute, San Sebastian, Spain;University Hospital, Department of Psychiatry and Psychotherapy, University of Leipzig, Leipzig, Germany;German Depression Foundation, Depression Research Centre, Leipzig, Germany;

关键词: Depression;    Cognitive behavioural therapy;    Internet-based;    Self-management;    Primary care;    Randomized controlled trial;   

DOI  :  10.1186/s12888-017-1306-2

 received in 2017-03-10, accepted in 2017-04-10,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundDuring the last decade online interventions have emerged as a promising approach for patients with mild/moderate depressive symptoms, reaching at large populations and representing cost-effective alternatives. The main objective of this double-blind, randomized controlled trial is to examine the efficacy of an internet-based self-management tool (iFightDepression) for mild to moderate depression as an add-on to treatment as usual (TAU) versus internet-based psychoeducation plus TAU.MethodsA total of 310 participants with major depression disorder (MDD) will be recruited at four different mental-health facilities in Spain. Participants will be randomly allocated to one of two study arms: iFightDepression (iFD) tool + TAU vs. internet-based psychoeducation + TAU. Both interventions last for 8 weeks and there is a 12 weeks follow up. The primary outcome measure is changes in depressive symptoms assessed with the Hamilton Depression Rating Scale. Additionally, pre-post interventions assessments will include socio-demographic data, a brief medical and clinical history and self-reported measures of depressive symptoms, quality of life, functional impairments and satisfaction with the iFD tool.DiscussioniFightDepression is an easy-prescribed tool that could increase the efficacy of conventional treatment and potentially reach untreated patients, shortening waiting lists to receive psychological treatment. Confirming the efficacy of the iFD internet-based self-management tool as an add-on treatment for individuals with mild to moderate depression will be clinically-relevant.Trial registrationRegistration number NCT02312583. Clinicaltrials.gov. December 4, 2014.

【 授权许可】

CC BY   
© The Author(s). 2017