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AgingGAMEPROAGINGNCT04982497

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

A study testing Video game based intervention in people with Aging and Aging Problems, run by University of Santiago de Compostela at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Aging Problems
What is being tested?
Video game based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
548 participants
Where
1 siteSpain
Study dates
21 Sep 2021to 31 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Research Group on Mental Health and Psychopatology

    Santiago de Compostela, A Coruña, 15782

Other trials in Spain

About this study

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.

Being tested
Video game based intervention, Control group
Keywords
video game, older adults, active aging, health promotion, study protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video game based interventionBehavioural

    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 groupOther

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

Study groups in NCT04982497
Study groupRoleWhat they receive
Video game based interventionExperimentalThe 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.
Receives: Behavioral: Video game based intervention
Control groupActive comparatorIndividuals assigned to this group will receive online therapeutically inactive information about active aging.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

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

    This will be measured with the General Health Questionnaire (GHQ-12; Goldberg \& Williams,1988; Spanish version by Rocha et al., 2011). This self-administered questionnaire consists of 12 items and assesses emotional distress. The person evaluates each item based on their emotional distress using a Likert scale with four response options ranging from "better than usual" to "much worse than usual," which are scored using a bimodal response scale (0, 0, 1, 1). The total score ranges from 0 to 12, with higher scores indicating greater emotional distress. The internal consistency (Cronbach's alpha) is .86 for people under 65 and .90 for people 65 and older.

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

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

    Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977; Spanish version by Vázquez et al., 2007). This 20- item scale is self-administered and assesses depressive symptoms. The person evaluates each item based on how often they have experienced it in the last week using a Likert scale with four response options ranging from 0 (rarely or none of the time) to 3 (most of the time). The total score ranges from 0 to 60, where higher scores correspond to greater depressive symptomatology. Internal consistency (Cronbach's alpha) of the scale is .89.

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

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

    To evaluate the reinforcement, we will use the Environmental Reward Observation Scale (EROS; Armento \& Hopko, 2007; Spanish version by Barraca \& Pérez-Álvarez, 2010). It is a self-administered 10-item scale that assesses the degree of positive reinforcement contingent on the response received from the media. Each item is evaluated based on the degree to which the individual believes applies to them, according to a Likert scale with four response options ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 10 to 40, with higher scores indicating more positive reinforcement. The internal consistency (Cronbach's alpha) of the Spanish version is .86.

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

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

    The occurrence of automatic negative thoughts will be assessed through the Automatic Thoughts Questionnaire (ATQ; Hollon \& Kendall, 1980; Spanish version by Otero et al., 2017). This is a 30-item self-report questionnaire that assesses negative thoughts. The subject must indicate the frequency for which a number of thoughts have suddenly arisen in their mind over the last week on a five-point scale from 1 (never) to 5 (always). Scores range between 30 and 150, with a higher score indicating more negative thoughts experienced by the subject. The ATQ's internal consistency (Cronbach's alpha) is .96.

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

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

    Self-reported memory will be measured with the Multifactorial Memory Questionnaire (MMQ; Troyer \& Rich, 2002). This 57-item self-administered test assesses subjective memory. Items are rated on a 5-point Likert scale based on the test taker's experiences over the previous two weeks. It comprises three dimensions: Contentment, Ability, and Strategy. Contentment measures satisfaction, concern, and overall appraisal of one's own memory; the score ranges from 0 to 72, with higher scores indicating greater satisfaction. The internal consistency is .95. Ability measures self-perception of everyday memory ability; the score range is 0 to 80, with higher scores indicating better self-reported memory ability, with an internal consistency of .93. Strategy measures the use of practical memory strategies in day-to-day life; the score range is 0 to 76, with higher scores indicating greater use of memory strategies. The internal consistency is .83.

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

  6. Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

    Participants' sleep hygiene behaviors will be assessed with the Sleep Hygiene Index (SHI; Mastin et al., 2006). It is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). The total score ranges from 0 to 52, with a higher score representing poorer sleep hygiene. Its internal consistency (Cronbach's alpha) is .66.

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

  7. Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

    Participants' physical activity will be assessed with the Brief Physical Activity Assessment Tool (BPAAT; Marshall et al., 2005; Spanish version by Puig et al., 2012). This two-item questionnaire measures the frequency and duration of moderate and vigorous physical activity in an individual's usual week. Combining the results of both questions, scores can range from 0 to 8, with a higher score indicating higher physical activity. In addition, the subject can be classified as sufficiently (≥4 score) or insufficiently active (0-3 score). The questionnaire has good test-retest reliability and content validity.

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

  8. Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

    Eating habits will be assessed with the Rapid Eating and Activity Assessment for Participants-Shortened Version (REAP-S; Segal-Isaacson et al., 2004 ). This 16-item scale assesses the consumption of different food groups. The total score ranges from 13 to 39, with a higher score representing better eating habits. This instrument has shown good convergent validity with the Block Semi Quantitative Food Frequency Questionnaire (Block, 1998), and is based on the Dietary Guidelines of the U.S. Department of Health and Human Services (Office of Disease Prevention and Health Promotion, 2015 ) and the Healthy People 2010 objectives (U.S.Department of Health and Human Services, 2000 ).

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

  9. Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

    The Body Mass Index (BMI) is a measure of nutritional status in adults. It is defined as an individual's weight in kilograms divided by the square of the height in meters (kg/m2) and classifies nutritional status as underweight, normal weight, pre-obesity, and obesity (I, II, and III).

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

  10. Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months

    Social support will be assessed with the Duke-UNC Functional Social Support Questionnaire (Duke-UNC-11; Broadhead et al., 1988 ; Spanish version by Bellón et al., 1996). This self-report 11-item test assesses perceived social support. Each item is rated on a 5-point scale ranging from 1 (never) to 5 (always). The total score ranges from 11 to 55, with a higher score representing more social support. Its internal consistency (Cronbach's alpha) is .90.

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

  11. Dropouts and treatment adherence

    Dropouts will be assessed by means of a register throughout the study. Treatment adherence will be automatically registered using both the online video game and the App by means of the number of modules completed by each participant, the time played, the time spent on cognitive tasks throughout the game and between session homework accomplishment.

    Measured: During the intervention sessions (8 weeks)

  12. Satisfaction with the service received

    Participant satisfaction with the service received will be evaluated upon intervention completion. We will use the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979; Spanish version by Vázquez et al., 2017). It is a 8-item scale with 4 possible answers and a final ranking score ranging from 8 to 32, where a higher score implies greater satisfaction with the service received. It has an internal consistency of .80.

    Measured: Post-intervention (9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start21 Sep 2021
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982497
Sponsor's protocol ID
PID2019-105052RB-I00
Acronym
GAMEPROAGING
Status last verified
Sep 2025
First submitted
23 Jul 2021
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Researchers will report study results through publications. The data supporting these findings will be presented in the main publications, and the datasets used during the study can be obtained from the corresponding author on reasonable request.

Publications

  • Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.

    PubMed 7783470
  • Armento ME, Hopko DR. The Environmental Reward Observation Scale (EROS): development, validity, and reliability. Behav Ther. 2007 Jun;38(2):107-19. doi: 10.1016/j.beth.2006.05.003. Epub 2006 Dec 12.

    PubMed 17499078
  • Bandura A. Social foundations of thought and action: A social cognitive theory: Englewood Cliffs, NJ, US: Prentice-Hall, Inc; 1986.

  • Barraca J, Pérez-Álvarez M. Adaptación española del Environmental Reward Observation Scale (EROS) [Spanish adaptation of the Environmental Reward Observation Scale (EROS)]. Ansiedad Estrés 16:95-107, 2010.

  • Bellon Saameno JA, Delgado Sanchez A, Luna del Castillo JD, Lardelli Claret P. [Validity and reliability of the Duke-UNC-11 questionnaire of functional social support]. Aten Primaria. 1996 Sep 15;18(4):153-6, 158-63. Spanish.

    PubMed 8962994
  • Block G. Invited commentary: comparison of the Block and the Willett food frequency questionnaires. Am J Epidemiol. 1998 Dec 15;148(12):1160-1; discussion 1162-5. doi: 10.1093/oxfordjournals.aje.a009601. No abstract available.

    PubMed 9867260
  • Broadhead WE, Gehlbach SH, de Gruy FV, Kaplan BH. The Duke-UNC Functional Social Support Questionnaire. Measurement of social support in family medicine patients. Med Care. 1988 Jul;26(7):709-23. doi: 10.1097/00005650-198807000-00006.

    PubMed 3393031
  • Ferrando L, Bobes J, Gibert J, Soto M, Soto O. MINI. Entrevista Neuropsiquiátrica Internacional. Versión en Español 5.0. [MINI. International Neuropsychiatric Interview. Spanish version 5.0] Madrid: Instituto IAP; 2000.

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204
  • Goldberg D, Williams P. A user's guide to the General Health questionnaire. Windsor, UK: NFER-Nelson. 1988.

  • Hollon SD, Kendall PC. Cognitive self-statements in depression: development of an Automatic Thoughts Questionnaire. Cognit Ther Res 4:383-95, 1980.

  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PubMed 10245370
  • Lewinsohn PM, Hoberman H, Teri L, Hautzinger M. An integrative theory of depression. In: Reiss S, Bootzin RR, editors. Theoretical issues in behaviour therapy. New York: Academic Press; 1985. p. 331-59.

  • Light LL. Memory and aging: four hypotheses in search of data. Annu Rev Psychol. 1991;42:333-76. doi: 10.1146/annurev.ps.42.020191.002001. No abstract available.

    PubMed 2018397
  • Lobo A, Saz P, Marcos G, Dia JL, de la Camara C, Ventura T, Morales Asin F, Fernando Pascual L, Montanes JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish.

    PubMed 10422057

Questions about this trial

What is this clinical trial studying?

A study testing Video game based intervention in people with Aging and Aging Problems, run by University of Santiago de Compostela at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months (time frame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04982497, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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