Gaming Applied to the Promotion of Active Aging

NCT03643237 | Completed DMC

• 1 other identifier: EXP - 00091195 / ITC-20161137
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Active aging programs have been recommended by the World Health Organization to help deal with the progressive aging of the population. However, older adults have difficulties in accessing these programs. Online video game-based interventions would improve their accessibility, while complementing these interventions with a mobile application (App) would increase adherence and professional monitoring. The main objective of this study is to assess the efficacy of an interactive, online, video game-based cognitive behavioral intervention with an App companion for active aging compared to a control group receiving therapeutically inactive information. The secondary objectives are to: (a) analyze the moderators of the change in the outcome variables and (b) evaluate adherence to the intervention. A randomized controlled trial will be performed including healthy adults older than 44. Recruitment of 180 participants is planned, with random allocation to one of the two conditions (90 participants per group): (a) an experimental group receiving an interactive, online, multimedia, video game-based cognitive behavioral intervention with an App companion (CCI-V) or (b) a control group receiving online therapeutically inactive information about active aging (CG). The intervention will be administered in 8 weekly modules comprised of 45-minute sessions. A blind evaluation will be conducted through online self-administered tests at baseline, post-intervention, and 6- and 12-month follow-up. The primary outcome will be the health status. Secondary outcomes will be emotional well-being, symptoms of depression, reinforcement, negative thoughts, self-reported memory, cognitive tasks, sleep hygiene, physical activity, eating habits, body mass index (BMI), social support, dropouts, treatment adherence, and satisfaction with the intervention.

Conditions

Aging; Aging Problems

Keywords

video game; older adults; active aging; health promotion; study protocol

Outcome Measures

Primary Outcomes (1)

• Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Health status will be measured with the 36-Item Short-Form Health Survey \[SF-36\]. This is a self-administered measure that assesses perceived health status. It contains 36 items that form 8 dimensions: General health, Physical functioning, Physical role functioning, Bodily pain, Vitality, Social functioning, Emotional role functioning, and Mental health. The 8 dimensions are obtained by recalibrating scores for 10 items, computing raw scales, and transforming them to a 0-100 scale. Dimension scores range from 0 to 100, with higher scores indicating better health status. Their internal consistencies (Cronbach's alphas) range from .71 to .94. These dimensions can be combined in two factors (Physical health and Mental health) with an average of 50 and a standard deviation of 10, and internal consistencies of .94 and .89, respectively.

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

Secondary Outcomes (13)

• Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

• Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

• Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

• Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

• Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months

Other Outcomes (3)

• Socio-demographic characteristics

  Pre-intervention

• Cognitive function

  Screening

• Diagnostic Interview

  Screening

Study Arms (2)

Video game-based intervention

EXPERIMENTAL

The participants in the experimental group will receive a cognitive-behavioral intervention for active aging via an interactive online multimedia video game with a complementary App. The intervention will consist of 8 modules each approximately 45 minutes long that will be administered at a rate of 1 per week with between-session homework.

Behavioral: Video game-based intervention

Control group

ACTIVE COMPARATOR

Individuals assigned to this group will receive online therapeutically inactive information about active aging.

Other: Control group

Interventions

Video game-based intervention BEHAVIORAL

The intervention will be administered via an online graphic-adventure video game. It includes 3 components: depression prevention, cognitive stimulation, and healthy habits promotion. The depression prevention component will be adapted from an indicated depression prevention program based on the model by Lewinsohn, Hoberman, Teri, \& Hautzinger, which is effective in short and long terms. The cognitive stimulation component is based on cognitive reserve and cerebral neuroplasticity. The healthy habits promotion component is based on the social learning and social cognitive theories. The App will allow participants to expand information, check progression, and receive reminders about homework

Video game-based intervention

Control group OTHER

The active control group will have access to a platform of online therapeutically inactive information related to active aging.

Control group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult older than 44 years old living in the Region of Galicia (Spain)
• accessibility to a personal computer and a smartphone with internet connection
• informed consent to participate in the study
• commitment to conduct the program and complete subsequent evaluations

You may not qualify if:

• serious neurological or mental disorder (depressive disorder, schizophrenia, bipolar disorder, major neurocognitive disorder, dissociative disorders, substance abuse and/or dependence)
• physical or psychological problems that prevent study implementation (e.g., severe auditory and/or visual loss)
• recent psychological or psychiatric treatment (in the past 2 months)
• participation in another trial

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• European Regional Development Fund: collaborator
• Center for Industrial Technological Development of Spain: collaborator

Study Sites (1)

Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, 15782, Spain

Location

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MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fernando L. Vázquez González, PhD

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Professor

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 22, 2018
• Study Start: November 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)