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

BACKGROUND: Depression 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 acces...

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Autores principales: Giosan, Cezar, Mogoaşe, Cristina, Cobeanu, Oana, Szentágotai Tătar, Aurora, Mureşan, Vlad, Boian, Rareș
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5192581/
https://www.ncbi.nlm.nih.gov/pubmed/28031038
http://dx.doi.org/10.1186/s13063-016-1740-3
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author Giosan, Cezar
Mogoaşe, Cristina
Cobeanu, Oana
Szentágotai Tătar, Aurora
Mureşan, Vlad
Boian, Rareș
author_facet Giosan, Cezar
Mogoaşe, Cristina
Cobeanu, Oana
Szentágotai Tătar, Aurora
Mureşan, Vlad
Boian, Rareș
author_sort Giosan, Cezar
collection PubMed
description BACKGROUND: Depression 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/DESIGN: Romanian-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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov: NCT02783118. Registered on 26 May 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The 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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spelling pubmed-51925812016-12-29 Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial Giosan, Cezar Mogoaşe, Cristina Cobeanu, Oana Szentágotai Tătar, Aurora Mureşan, Vlad Boian, Rareș Trials Study Protocol BACKGROUND: Depression 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/DESIGN: Romanian-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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov: NCT02783118. Registered on 26 May 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1740-3) contains supplementary material, which is available to authorized users. BioMed Central 2016-12-28 /pmc/articles/PMC5192581/ /pubmed/28031038 http://dx.doi.org/10.1186/s13063-016-1740-3 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Giosan, Cezar
Mogoaşe, Cristina
Cobeanu, Oana
Szentágotai Tătar, Aurora
Mureşan, Vlad
Boian, Rareș
Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title_full Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title_fullStr Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title_full_unstemmed Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title_short Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
title_sort using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: study protocol of an exploratory randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5192581/
https://www.ncbi.nlm.nih.gov/pubmed/28031038
http://dx.doi.org/10.1186/s13063-016-1740-3
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