Development and Evaluation of a Psychological Intervention in Videogame Format for the Promotion of Active Aging

NCT ID: NCT04982497

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2024-05-31

Brief Summary

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The social and health challenges of the aging population have led to the recommendation of active aging programs to increase the number of healthy and independent elderly people. These interventions have been shown to offer benefits in terms of quality of life, wellbeing, dietary and physical exercise habits, and cultural and social activity. However, there is a current need to investigate more-effective alternative means to disseminate these interventions beyond in-person formats such as serious videogames, aimed at promoting behavioral changes and providing education for purposes such as health or learning. The main objective of this project is to improve on a videogame intervention for the promotion of aging and to evaluate its efficacy via a randomized controlled trial. It is expected that after the intervention and in the follow-ups (at 3, 6, and 12 months), participants in the videogame arm of the study will have higher health status compared to the control group subjects. The first months of the study will be devoted to revising the materials and fine-tuning the intervention tested in a previous pilot study. After that, the randomized controlled trial will be conducted. Participants will be recruited through clinics and health care centers in the Autonomous Community of Galicia (Spain). To participate in the study, participants must: (a) be at least 45 years old, (b) have normal cognitive functioning, and (c) reside in Galicia. Participants will be excluded if they: (a) have serious mental or medical disorders; (b) have been receiving psychological or psychopharmacological treatment during the two months prior to the study or are participating in other studies related to active aging; and finally, (c) do not have the appropriate devices to play the game, cannot communicate in Spanish, or have problems that make it impossible to play the videogame. Information on various sociodemographic and clinical variables will be collected during the pre-intervention evaluation. The main outcome will be perceived health status, as evaluated using the SF-36 health questionnaire. A total of 548 participants will be randomly assigned to a cognitive-behavioral intervention administered through a serious online interactive multimedia game with a complementary App (CBI-V, experimental group) or to a control group that will receive information on active aging in an online format (CG). The randomization sequence will be generated automatically by the evaluation platform (concealment or blinding of randomization), and the participants in the CBI-V group will be given access to the first module of the intervention, while those in the CG will receive the first informational module. The participants in both groups will then complete the next seven modules for each condition. After the intervention, the participants will be evaluated in the postintervention assessment and follow-up assessments at 3, 6 and 12 months. In terms of its impact, this study will contribute to the development and rigorous evaluation of the worlds first psychological intervention to promote active aging managed through an interactive online multimedia videogame with a complementary app. In addition, confirmation of the programs clinical validity will be of great relevance in terms of health, social and economic benefits.

Detailed Description

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Conditions

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Aging Aging Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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 70 (±25) 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 prevention program based on the model by Lewinsohn et al. (1985). The cognitive stimulation component is based on cognitive reserve (Tucker \& Stern, 2011) and neuroplasticity (Shapiro, 2001), the cognitive stimulation model by Spector et al. (2006), and the causes of age-related memory failures (Light, 1991) (e.g., decrease in the processing resources, semantic coding deficit, difficulties in deliberate information retrieval). The healthy habits promotion component is based on the social learning and social cognitive theories (Bandura, 1986; Spiegler, 2016).

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

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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 prevention program based on the model by Lewinsohn et al. (1985). The cognitive stimulation component is based on cognitive reserve (Tucker \& Stern, 2011) and neuroplasticity (Shapiro, 2001), the cognitive stimulation model by Spector et al. (2006), and the causes of age-related memory failures (Light, 1991) (e.g., decrease in the processing resources, semantic coding deficit, difficulties in deliberate information retrieval). The healthy habits promotion component is based on the social learning and social cognitive theories (Bandura, 1986; Spiegler, 2016).

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

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Inclusion Criteria

* Be at least 45 years old.
* Have normal cognitive functioning.
* Reside in the region of Galicia (Spain).

Exclusion Criteria

* Have serious mental or medical disorders (e.g., severe depression, schizophrenia, bipolar disorder, dementia, dissociative disorders, substance dependence, acute suicidal ideation).
* Recent psychological or psychiatric treatment (in the past 2 months), or participation in another trial related to active aging.
* Do not have the appropriate devices to play the game (computer and smartphone with internet connection), cannot communicate in Spanish, or have problems (e.g., sensory, physical) that make it impossible to play the videogame.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State Research Agency, Spain

OTHER_GOV

Sponsor Role collaborator

University of Santiago de Compostela

OTHER

Sponsor Role lead

Responsible Party

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Fernando Lino Vázquez González

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando L. Vázquez González, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Ángela J. Torres Iglesias, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

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Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, Spain

Site Status

Countries

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Spain

References

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Other Identifiers

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PID2019-105052RB-I00

Identifier Type: -

Identifier Source: org_study_id

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