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Randomized Controlled Trial
. 2017 Apr 19;17(1):143.
doi: 10.1186/s12888-017-1306-2.

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

Azucena Justicia  1   2   3   4 , Matilde Elices  5   6 , Ana Isabel Cebria  5   7   8 , Diego J Palao  5   7   8 , Jesús Gorosabel  9 , Dolors Puigdemont  5   10 , Javier de Diego-Adeliño  5   7   10 , Andrea Gabilondo  11 , Alvaro Iruin  11 , Ulrich Hegerl  12   13 , Víctor Pérez  5   7   14   6
Affiliations
Randomized Controlled Trial

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

Azucena Justicia et al. BMC Psychiatry. .

Abstract

Background: During 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.

Methods: A 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.

Discussion: iFightDepression 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 registration: Registration number NCT02312583 . Clinicaltrials.gov . December 4, 2014.

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

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Figures

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Fig. 1
Flowchart of participants
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