Gaming Applied to the Promotion of Active Aging

NCT ID: NCT03643237

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-31

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.

Detailed Description

European population aging has increased in the last several decades: 19.1% of Europeans are currently older than 65, and 39.2% are over 50. Depression and dementia are some of the most prevalent conditions in older adults, and both have high socioeconomic costs. In this context, the World Health Organization has pointed out the importance of active aging promotion programs to help older adults maintain their independence and health for longer. In addition, healthy life habits such as physical activity and eating a balanced diet also help prevent disease and preserve mental and physical functions.

However, the lack of health care services for older adults, especially in rural areas which tend to have more older people, may limit access to active aging programs targeting depression, cognitive decline, and healthy habits. One way to overcome these barriers is through online video games that are accessible at home at any time with a low cost. However, the efficacy of video games in promoting active aging from middle to late adulthood has received very little attention in the literature.

A meta-analysis of 21 randomized controlled trials about video game-based interventions administered to healthy adults over 44 found that video game-based interventions produced positive effects on negative affect, objectively measured physical and social health with small effect sizes. However, the reviewed studies used non-standardized measures, and follow-ups were scarce. There was only one video game designed to prevent depression in older people. Furthermore, none of the reviewed studies involved integral interventions for emotional wellbeing, cognitive stimulation, or healthy life habits, even though a review of modifiable risk factors for dementia estimated that 51% of population-attributable risk was associated with cognitive inactivity, depression, physical inactivity, and obesity; and these midlife risk factors could be tackled early to prevent or delay the onset of dementia.

This study will assess the efficacy of an interactive, online, video game-based cognitive behavioral intervention to promote active aging from an integral health perspective, targeting emotional well-being, cognition, healthy life habits (sleep hygiene, physical activity, and eating habits), and social support.

Randomization will occur after screening and baseline assessments. An independent researcher (allocation concealment) will make allocation cards using computer-generated random numbers. He will keep the original random allocation sequences in an inaccessible location and will work with a copy. The randomization sequence will be communicated to the researchers in sealed numbered envelopes, one for each participant, with instructions to use them in numerical order.

Sample size calculation: We estimate that a sample size of 78 participants per group will be required, based on a previous meta-analysis of video game-based interventions for active aging reported effect sizes for mood and objectively measured physical health of 0.26 and 0.34, respectively, and another meta-analysis of video games for training cognition in older adults reported an effect size of 0.37, and assuming 80% power at a 0.05 (two-tailed) significance level and a mean of 8% attrition. To safeguard against an estimated 12% to 15% loss to follow-up, a minimum of 180 participants (90 in each group) must be recruited.

Ethics: Ethics approval has been obtained from the Bioethics Committee of the University of Santiago de Compostela (Spain), and the project complies with the Declaration of Helsinki. The confidentiality of all participants will be guaranteed. Participants will have to give their informed consent, which has been approved by the Bioethics Committee of the University of Santiago de Compostela (Spain).

Conditions

Aging; Aging Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Video game-based intervention

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.

Group Type: EXPERIMENTAL

Video game-based intervention

Intervention Type: 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

Control group

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

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

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

Interventions

Video game-based intervention

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

Intervention Type: BEHAVIORAL

Control group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Regional Development Fund

OTHER

Sponsor Role: collaborator

Center for Industrial Technological Development of Spain

UNKNOWN

Sponsor Role: collaborator

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Fernando Lino Vázquez González

Tenured Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando L. Vázquez González, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, Spain

Countries

Spain

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Other Identifiers

EXP - 00091195 / ITC-20161137

Identifier Type: -

Identifier Source: org_study_id