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

NCT04982497 | Completed

• 1 other identifier: PID2019-105052RB-I00
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 3, 6 and 12 months

  Health status will be measured with the 36-Item Short-Form Health Survey \[SF-36\] (SF-36; Ware \& Shebourne, 1992; Spanish version by Alonso et al., 1995 ). 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 3, 6 and 12 months

Secondary Outcomes (12)

• Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow- ups at 3, 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

  Pre- and post-intervention (9 weeks) with follow-ups at 3, 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 70 (±25) 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 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).

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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• State Research Agency, 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

• Ángela J. Torres Iglesias, 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: Full Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: September 21, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)