AgingGAMAPEANCT03643237
Gaming Applied to 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.
Trial 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. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Research Group on Mental Health and Psychopatology
Santiago de Compostela, A Coruña, 15782
About this study
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.
Read the 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
- 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 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 groupOther
The active control group will have access to a platform of online therapeutically inactive information related to active aging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Video game-based intervention |
| Control group | Active comparator | Individuals 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.
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.
Measured: 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
This will be measured with the General Health Questionnaire [GHQ-12]. 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 6 and 12 months
Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale [CES-D]. 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 6 and 12 months
Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 6 and 12 months
To evaluate the reinforcement, we will use the Environmental Reward Observation Scale [EROS]. 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 6 and 12 months
Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow-ups at 6 and 12 months
The occurrence of automatic negative thoughts will be assessed through the Automatic Thoughts Questionnaire [ATQ]. 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 6 and 12 months
Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Self-reported memory will be measured with the Multifactorial Memory Questionnaire [MMQ]. 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 6 and 12 months
Cognitive tasks
The number of cognitive tasks completed during the video game will be counted and registered.
Measured: During the intervention sessions (8 weeks)
Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Participants' sleep hygiene behaviors will be assessed with the Sleep Hygiene Index [SHI]. 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 6 and 12 months
Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Participants' physical activity will be assessed with the Brief Physical Activity Assessment Tool [BPAAT]. 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 6 and 12 months
Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Eating habits will be assessed with the Rapid Eating and Activity Assessment for Participants-Shortened Version [REAP-S]. 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 and is based on the Dietary Guidelines of the U.S. Department of Health and Human Services (Office of Disease Prevention and Health Promotion) and the Healthy People 2010 objectives.
Measured: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 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 6 and 12 months
Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Social support will be assessed with the Duke-UNC Functional Social Support Questionnaire [Duke-UNC-11]. 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 6 and 12 months
Drop outs and treatment adherence
Dropouts and treatment adherence will be assessed through frequency, duration playing the videogame and between-session homework accomplishment. It will be automatically registered and monitored through the online platform and the App companion.
Measured: During the intervention sessions (8 weeks)
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]. 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.
- First posted22 Aug 2018
- Study start1 Nov 2018
- Primary completion31 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Center for Industrial Technological Development of Spain
- Responsible party
- Principal investigator, Fernando Lino Vázquez González, University of Santiago de Compostela
- Investigators
- Fernando L. Vázquez González, PhD, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643237
- Sponsor's protocol ID
- EXP - 00091195 / ITC-20161137
- Acronym
- GAMAPEA
- Status last verified
- Mar 2020
- First submitted
- 5 Aug 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7783470Armento 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 17499078Ballesteros S, Prieto A, Mayas J, Toril P, Pita C, Ponce de Leon L, Reales JM, Waterworth J. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial. Front Aging Neurosci. 2014 Oct 14;6:277. doi: 10.3389/fnagi.2014.00277. eCollection 2014.
PubMed 25352805Bandura A. Social foundations of thought and action: A social cognitive theory: Englewood Cliffs, NJ, US: Prentice-Hall, Inc; 1986.
Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.
PubMed 21775213Barraca 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 8962994Bertolini P, Pisano E, Sivini S, Scaramuzzi S. Poverty and social exclusion in rural areas: European Commission. Directorate-General for Employment, Social Affairs and Equal Opportunities; 2008.
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 9867260Broadhead 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 3393031Buitenweg JIV, van de Ven RM, Prinssen S, Murre JMJ, Ridderinkhof KR. Cognitive Flexibility Training: A Large-Scale Multimodal Adaptive Active-Control Intervention Study in Healthy Older Adults. Front Hum Neurosci. 2017 Nov 1;11:529. doi: 10.3389/fnhum.2017.00529. eCollection 2017.
PubMed 29209183DeSmet A, Van Ryckeghem D, Compernolle S, Baranowski T, Thompson D, Crombez G, Poels K, Van Lippevelde W, Bastiaensens S, Van Cleemput K, Vandebosch H, De Bourdeaudhuij I. A meta-analysis of serious digital games for healthy lifestyle promotion. Prev Med. 2014 Dec;69:95-107. doi: 10.1016/j.ypmed.2014.08.026. Epub 2014 Aug 27.
PubMed 25172024Eurostat. European Commission. Rural development statistics by urban-rural typology: Eurostat 2013. Report No.: 9282869342. Available from http://ec.europa.eu/eurostat/statistics-explained/index.php/Rural_development_statistics_by_urban-rural_typology [Accessed 5 August 2018]
Eurostat. Population data 2017. 2017. Available from: http://ec.europa.eu/eurostat/data/database?node_code=proj. [Accessed on 3rd August 2017];
Farre M, Haro JM, Kostov B, Alvira C, Risco E, Miguel S, Cabrera E, Zabalegui A. Direct and indirect costs and resource use in dementia care: A cross-sectional study in patients living at home. Int J Nurs Stud. 2016 Mar;55:39-49. doi: 10.1016/j.ijnurstu.2015.10.012. Epub 2015 Nov 19.
PubMed 26632506
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaming Applied to the Promotion of Active Aging
- ClinicalTrials.gov ID
- NCT03643237
- Acronym / sponsor ID
- GAMAPEA / EXP - 00091195 / ITC-20161137
- Conditions
- Aging, Aging Problems
- Keywords
- video game, older adults, active aging, health promotion, study protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Center for Industrial Technological Development of Spain
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game-based intervention | Experimental | Behavioral: Video game-based interventionThe 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. |
| Control group | Active comparator | Other: Control groupIndividuals assigned to this group will receive online therapeutically inactive information about active aging. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video game-based interventionThe 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 | Behavioural | Video game-based intervention |
| Control groupThe active control group will have access to a platform of online therapeutically inactive information related to active aging. | Other | Control group |
Primary outcome
Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with 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.
13 secondary outcomes
Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Cognitive tasks
Time frame: During the intervention sessions (8 weeks)
Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 6 and 12 months
Time frame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Drop outs and treatment adherence
Time frame: During the intervention sessions (8 weeks)
Satisfaction with the service received
Time frame: Post-intervention (9 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 7783470Alonso 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.
- Background: PubMed 17499078Armento 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.
- Background: PubMed 25352805Ballesteros S, Prieto A, Mayas J, Toril P, Pita C, Ponce de Leon L, Reales JM, Waterworth J. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial. Front Aging Neurosci. 2014 Oct 14;6:277. doi: 10.3389/fnagi.2014.00277. eCollection 2014.
- BackgroundBandura A. Social foundations of thought and action: A social cognitive theory: Englewood Cliffs, NJ, US: Prentice-Hall, Inc; 1986.
- Background: PubMed 21775213Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.
- BackgroundBarraca 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.
- Background: PubMed 8962994Bellon 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.
- BackgroundBertolini P, Pisano E, Sivini S, Scaramuzzi S. Poverty and social exclusion in rural areas: European Commission. Directorate-General for Employment, Social Affairs and Equal Opportunities; 2008.
- Background: PubMed 9867260Block 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.
- Background: PubMed 3393031Broadhead 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.
- Background: PubMed 29209183Buitenweg JIV, van de Ven RM, Prinssen S, Murre JMJ, Ridderinkhof KR. Cognitive Flexibility Training: A Large-Scale Multimodal Adaptive Active-Control Intervention Study in Healthy Older Adults. Front Hum Neurosci. 2017 Nov 1;11:529. doi: 10.3389/fnhum.2017.00529. eCollection 2017.
- Background: PubMed 25172024DeSmet A, Van Ryckeghem D, Compernolle S, Baranowski T, Thompson D, Crombez G, Poels K, Van Lippevelde W, Bastiaensens S, Van Cleemput K, Vandebosch H, De Bourdeaudhuij I. A meta-analysis of serious digital games for healthy lifestyle promotion. Prev Med. 2014 Dec;69:95-107. doi: 10.1016/j.ypmed.2014.08.026. Epub 2014 Aug 27.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando L. Vázquez González, PhD principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
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 4 inclusion and 4 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 24 Mar 2020. 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 6 and 12 months (time frame: Pre- and post-intervention (9 weeks) with follow-ups at 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 NCT03643237, which also lists 54 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 24 Mar 2020.