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

Abstract

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 registrationClinicalTrials.gov: NCT02783118. Registered on 26 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1740-3) contains supplementary material, which is available to authorized users.

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial

“…The following measures have been adapted into Romanian and successfully used in two previous trials testing another version of the app, and they have shown adequate psychometric properties [ 36 ].…”

“…Information on the development of the application and its clinical relevance has been presented at several international and national conferences. A first exploratory study protocol on the efficacy of the app in reducing cognitive vulnerability and mild depressive symptoms has already been published [ 36 ]. More information regarding research progress and dissemination can be found at the project’s designated website [ 60 ].…”

Mental health service users' and professionals' relationship with games and gaming

“…18 Currently, several trials are ongoing to investigate gamification as an intervention tool in different domains of mental health and mental healthcare. 19…”

“…18 Currently, several trials are ongoing to investigate gamification as an intervention tool in different domains of mental health and mental healthcare. 19 Utilizing digital games in mental health services requires information not only on their effects but also on the perceptions, attitudes and experiences of both service users and professionals regarding games and gaming. However, research on these topics is currently scarce.…”

Analysis and Development of a Platform for Generating Context-Aware Apps for Mental Health

“…Exploiting larger screen resolutions and multimedia capabilities, one finds examples of multimodal learning materials using both audio and video guides [133,167], using pictures [83, 86-88, 117, 129], audio [83,87,88,117], music [86][87][88] and video [83,88,156]. Leveraging the improved connectivity and ubiquity of smartphones, some authors offer access to entire online libraries of learning materials [127,167]; others utilize in-app prompting as intervention techniques, e.g., sending reminders to use the app [87,103,104,118,159], motivational messages [70] or messages from the therapist [90,163]. Exploiting the improved interactivity of smartphones, we find interactive quizzes for training skills and improved learning [78,127], assessments for panic attacks [144], suicidal intentions [122], symptoms Chapter 2.…”