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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

Cognitive-behavioral intervention via interactive multimedia online video game for active aging: study protocol for a randomized controlled trial

Authors: Fernando L. Vázquez, Ángela J. Torres, Patricia Otero, Vanessa Blanco, Lara López, Antonio García-Casal, Manuel Arrojo

Published in: Trials | Issue 1/2019

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Abstract

Background

Due to the progressive aging of the population, programs to promote active aging have been recommended. However, older adults have difficulty accessing them. Interventions administered through online video games may increase their accessibility, and complementing these with a smartphone app will likely increase adherence and allow for ongoing professional monitoring. The objective of this study is to evaluate the efficacy of a cognitive-behavioral intervention for active aging administered through an online interactive multimedia video game that includes a smartphone app companion. The secondary objectives are to analyze the moderators and mediators of the change in the outcome variables and to evaluate the adherence to the intervention.

Methods/design

A randomized controlled clinical trial will be conducted. Adults 45 years and older will be randomly assigned to a cognitive-behavioral intervention administered through an online multimedia video game that includes a smartphone app companion or to a control group that will receive online information on active aging (274 participants per group). The intervention will be administered in eight weekly 45-min modules. An investigator-blinded evaluation will be conducted using online self-administered tests at baseline, post-intervention, and 6- and 12-month follow-ups. The primary outcome will be mental health status as evaluated using the 36-item Short-Form Health Survey (SF-36) at post-intervention. Secondary outcomes will be emotional well-being, depressive symptoms, reinforcement, negative thoughts, self-reported memory, cognitive task performance, sleep hygiene behaviors, physical activity, eating habits, body mass index, social support, dropout, treatment adherence, and satisfaction with the intervention.

Discussion

If the results are favorable, this study would involve the development of the first evidence-based active aging promotion intervention based on a video game that includes a smartphone app companion, providing evidence on its efficacy, accessibility, and clinical utility.

Trial registration

ClinicalTrials.gov, NCT03643237. Registered 27 August 2018.
Appendix
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Metadata
Title
Cognitive-behavioral intervention via interactive multimedia online video game for active aging: study protocol for a randomized controlled trial
Authors
Fernando L. Vázquez
Ángela J. Torres
Patricia Otero
Vanessa Blanco
Lara López
Antonio García-Casal
Manuel Arrojo
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3859-5

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