Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trialReport as inadecuate

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, 17:609

First Online: 28 December 2016Received: 07 June 2016Accepted: 04 December 2016DOI: 10.1186-s13063-016-1740-3

Cite this article as: Giosan, C., Cobeanu, O., Mogoaşe, C. et al. Trials 2016 17: 609. doi:10.1186-s13063-016-1740-3


BackgroundDepression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Therefore, we need effective and widely accessible strategies to prevent the onset of the very first depressive symptoms. Mental health apps could prove a valuable solution for this desideratum. Although preliminary research has indicated that such apps can be useful in treating depression, no study has attempted to test their utility in preventing depressive symptoms. The aim of this exploratory study is to contrast the efficacy of a smartphone app in reducing cognitive vulnerability and mild depressive symptoms, as risk factors for the onset of depression, against a wait-list condition. More specifically, we aim to test an app designed to 1 decrease general cognitive vulnerability and 2 promote engagement in protective, adaptive activities, while 3 counteracting through gamification and customization the tendency of premature dropout from intervention.

Methods-designRomanian-speaking adults 18 years and older with access to a computer and the Internet and who own a smartphone are included in the study. Two parallel randomized clinical trials are conducted: in the first one, 50 participants free of depressive symptoms i.e., who obtain scores ≤4 on the Patient Health Questionnaire, PHQ-9 will be included, while in the second one 50 participants with minimal depressive symptoms i.e., who obtain PHQ-9 scores between 5 and 9 will be included. Participants undergoing therapy, presenting with substance abuse problems, psychotic symptoms, and organic brain disorders, or serious legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active intervention will autonomously use the smartphone app for 4 weeks, while the others will be given access to the app after 4 weeks from randomization. The primary outcomes are 1 cognitive vulnerability factors as defined within the cognitive behavioral therapy CBT paradigm i.e., dysfunctional cognitions, irrational beliefs, and negative automatic thoughts for the first trial, and 2 level of depressive symptomatology for the second trial. The app includes self-help materials and exercises based on CBT for depression, presented in a tailored manner and incorporating gamification elements aimed at boosting motivation to use the app.

DiscussionThis study protocol is the first to capitalize on the ubiquity of smartphones to large-scale dissemination of CBT-based strategies aimed at preventing depression in non-clinical populations.

Trial NCT02783118. Registered on 26 May 2016.

KeywordsDepression Prevention Protocol Randomized trial CBT Smartphone app AbbreviationsATQAutomatic Thoughts Questionnaire

BADS-SFBehavioral Activation for Depression Scale - Short Form

BSBeliefs Scale

CBTCognitive behavioral therapy

CESD-RCenter for Epidemiologic Studies Depression Scale-Revised

DASDysfunctional Attitude Scale

DAS-SFDysfunctional Attitudes Scale - Short Form

DSM-IV-TRDiagnostic and Statistical Manual of Mental Disorders 4th edition

GDBGlobal disease burden

PANASPositive and Negative Affect Scale

PHQ-9Patient Health Questionnaire, 9-item version

REBTRational emotive behavior therapy

SWLSatisfaction with Life

WHOWorld Health Organization

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1740-3 contains supplementary material, which is available to authorized users.

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Author: Cezar Giosan - Oana Cobeanu - Cristina Mogoaşe - Aurora Szentágotai Tătar - Vlad Mureşan - Rareș Boian


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