Older Adults (65 Years and Older)NCT07615647
How Video Game Therapy Affects Thinking and Emotions in Older Adults With Cognitive Impairment
A study testing Videogames masterclass and Therapy with videogames in people with Older Adults (65 Years and Older) and Cognitive Impairment, Mild, run by Golden Gamers Go SL at 1 site in Spain.
Trial summary
Golden Gamers Go is running a study together with Rey Juan Carlos University to better understand how videogames can help older adults, especially those with memory problems or cognitive decline. The study takes place in real care settings, such as day centers, and involves around 45 older participants. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults (65 Years and Older), Cognitive Impairment, Mild
- What is being tested?
- Videogames masterclass and Therapy with videogames
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2026to 6 Jul 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults with mild to moderate cognitive impairment, able to connect with their environment and participate in group or individual activities, and who agree to take part in the study.
Who cannot join
- Severe cognitive impairment with lack of environmental awareness, serious visual limitations that prevent interaction, or any condition causing distress or making participation unsafe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COGNITIVE AND AFFECTIVE-MOTIVATIONAL EFFECTS OF A THERAPEUTIC INTERVENTION USING THE GOLDEN GAMERS METHODOLOGY IN OLDER ADULTS WITH COGNITIVE IMPAIRMENT
Golden Gamers Go is running a study together with Rey Juan Carlos University to better understand how videogames can help older adults, especially those with memory problems or cognitive decline.
The study takes place in real care settings, such as day centers, and involves around 45 older participants. Over two months (with a possible follow-up period), participants take part in two to three sessions per week using video games on PlayStation.
Read more
These are not special "health games," but popular, commercial video games that have been carefully selected and adapted to be easy to use, enjoyable, and meaningful for older adults.
The goal is to see whether playing these games can help improve thinking abilities and also how participants feel during the activity - for example, if they are more engaged, motivated, or emotionally positive.
This study builds on previous experience where this approach has already shown promising results in increasing participation, motivation, and overall wellbeing.
By carrying out this research, Golden Gamers Go aim to better understand how meaningful and enjoyable activities like videogames can support healthier and more active aging.
- Being tested
- Videogames masterclass, Therapy with videogames
- Keywords
- Alzheimer, Senior, Videogames, Therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogames masterclassProcedure or surgery
Also called Golden Gamers Methodology
This masterclass sessions are carried out in small groups. It talks about the use of certain videogames and VR devices for improving the health of the participants.
Each session begins with a simple introduction, and end with a short group reflection, and professionals record participation and responses to guide future sessions.
The vidoegames that will be described and shown for the users experience are some that have a high degree of accesibility from the Golden Gamers Methodology perspective.
Therapy with videogamesProcedure or surgery
Therapy sessions are carried out in small groups using adapted comercial videogames.
Each session begins with a simple introduction, followed by gameplay with continuous support. Participants can engage in different ways (playing, assisting, or observing), depending on their needs. Sessions end with a short group reflection, and professionals record participation and responses to guide future sessions.
There a lot of unique aspects for this approach. First, the use of comercial videogames for therapy, instead of serious games. Therefore, the whole process is guided by the Golden Gamers Methodology, specialiced in cognitive accesibility. The combination of this kind of videogames, with this adaptations in a senior population with cognitive impairment is totally different from other studies.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive intervention through conventional videogames Receives: Procedure: Therapy with videogames |
| Control group | Active comparator | Control group will receive a special talk about the uses of conventional videogames Receives: Procedure: Videogames masterclass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
Measures overall cognitive function (memory, attention, language, orientation, etc.). The total score ranges from 0 to 30 points. Higher scores indicate better cognitive performance. The standard administration guidance states that 26/30 or above is generally considered within the normal range, although cut-off points may vary depending on population, education level, age and clinical context.
Measured: General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
Observed Emotion Rating Scale (OERS)
Measures emotional state during the sessions (positive and negative emotions observed).The OERS measures the intensity or duration of these affective states using a 5-point Likert-type scale. Each emotional state is rated separately, usually from 1 to 5.
A higher score in pleasure is positive. A higher score in general alertness is usually positive or activation-related. Higher scores in anger, anxiety/fear or sadness indicate more negative affect.
Measured: Pre-intervention and post-intervention (up to 1 week)
Menorah Park Engagement Scale (MPES)
The adapted MPES assesses participant engagement during the activity using a 5-point duration scale aligned with the OERS. Observation takes place during the central 10 minutes of the session, from minute 15 to minute 25, to avoid start-up or fatigue bias. Each engagement category is scored according to the total accumulated time observed: 1 means the behaviour was never observed; 2 indicates a very brief occurrence; 3 indicates a short occurrence; 4 means the behaviour was observed for 1 to 5 minutes; and 5 means it was observed for more than 5 minutes. The categories assessed are constructive engagement, passive engagement, social engagement, non-engagement and self-engagement. If two behaviours occur at the same time, constructive engagement is prioritised.
Measured: Pre-intervention and post-intervention (up to 1 week)
Quality of Life in Alzheimer's Disease (QoL-AD, proxy version)
The QoL-AD proxy version assesses perceived quality of life in people with cognitive impairment through the judgement of a caregiver, professional or informant who knows the participant well. It includes 13 items, each scored on a 4-point scale: 1 means poor, 2 means fair, 3 means good and 4 means excellent. The total score is obtained by adding the 13 item scores, giving a possible range from 13 to 52 points. Higher scores indicate better perceived quality of life.
Measured: General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start13 Apr 2026
- Primary completion15 Jun 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Gamers Go SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina García Bravo, PhD, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615647
- Sponsor's protocol ID
- 100220261372026
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGNITIVE AND AFFECTIVE-MOTIVATIONAL EFFECTS OF A THERAPEUTIC INTERVENTION USING THE GOLDEN GAMERS METHODOLOGY IN OLDER ADULTS WITH COGNITIVE IMPAIRMENT
- ClinicalTrials.gov ID
- NCT07615647
- Acronym / sponsor ID
- 100220261372026
- Keywords
- Alzheimer, Senior, Videogames, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Golden Gamers Go SLUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 29 May 2026 (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.
Golden Gamers Go is running a study together with Rey Juan Carlos University to better understand how videogames can help older adults, especially those with memory problems or cognitive decline.
The study takes place in real care settings, such as day centers, and involves around 45 older participants. Over two months (with a possible follow-up period), participants take part in two to three sessions per week using video games on PlayStation.
These are not special "health games," but popular, commercial video games that have been carefully selected and adapted to be easy to use, enjoyable, and meaningful for older adults.
The goal is to see whether playing these games can help improve thinking abilities and also how participants feel during the activity - for example, if they are more engaged, motivated, or emotionally positive.
This study builds on previous experience where this approach has already shown promising results in increasing participation, motivation, and overall wellbeing.
By carrying out this research, Golden Gamers Go aim to better understand how meaningful and enjoyable activities like videogames can support healthier and more active aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Therapy with videogamesThe experimental group will receive intervention through conventional videogames |
| Control group | Active comparator | Procedure: Videogames masterclassControl group will receive a special talk about the uses of conventional videogames |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older adults with mild to moderate cognitive impairment, able to connect with their environment and participate in group or individual activities, and who agree to take part in the study.
Key exclusion criteria (1 listed)
- Severe cognitive impairment with lack of environmental awareness, serious visual limitations that prevent interaction, or any condition causing distress or making participation unsafe.
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 |
|---|---|---|
| Videogames masterclassAlso: Golden Gamers MethodologyThis masterclass sessions are carried out in small groups. It talks about the use of certain videogames and VR devices for improving the health of the participants. Each session begins with a simple introduction, and end with a short group reflection, and professionals record participation and responses to guide future sessions. The vidoegames that will be described and shown for the users experience are some that have a high degree of accesibility from the Golden Gamers Methodology perspective. | Procedure or surgery | Control group |
| Therapy with videogamesTherapy sessions are carried out in small groups using adapted comercial videogames. Each session begins with a simple introduction, followed by gameplay with continuous support. Participants can engage in different ways (playing, assisting, or observing), depending on their needs. Sessions end with a short group reflection, and professionals record participation and responses to guide future sessions. There a lot of unique aspects for this approach. First, the use of comercial videogames for therapy, instead of serious games. Therefore, the whole process is guided by the Golden Gamers Methodology, specialiced in cognitive accesibility. The combination of this kind of videogames, with this adaptations in a senior population with cognitive impairment is totally different from other studies. | Procedure or surgery | Experimental group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
Measures overall cognitive function (memory, attention, language, orientation, etc.). The total score ranges from 0 to 30 points. Higher scores indicate better cognitive performance. The standard administration guidance states that 26/30 or above is generally considered within the normal range, although cut-off points may vary depending on population, education level, age and clinical context.
Observed Emotion Rating Scale (OERS)
Time frame: Pre-intervention and post-intervention (up to 1 week)
Measures emotional state during the sessions (positive and negative emotions observed).The OERS measures the intensity or duration of these affective states using a 5-point Likert-type scale. Each emotional state is rated separately, usually from 1 to 5. A higher score in pleasure is positive. A higher score in general alertness is usually positive or activation-related. Higher scores in anger, anxiety/fear or sadness indicate more negative affect.
Menorah Park Engagement Scale (MPES)
Time frame: Pre-intervention and post-intervention (up to 1 week)
The adapted MPES assesses participant engagement during the activity using a 5-point duration scale aligned with the OERS. Observation takes place during the central 10 minutes of the session, from minute 15 to minute 25, to avoid start-up or fatigue bias. Each engagement category is scored according to the total accumulated time observed: 1 means the behaviour was never observed; 2 indicates a very brief occurrence; 3 indicates a short occurrence; 4 means the behaviour was observed for 1 to 5 minutes; and 5 means it was observed for more than 5 minutes. The categories assessed are constructive engagement, passive engagement, social engagement, non-engagement and self-engagement. If two behaviours occur at the same time, constructive engagement is prioritised.
Quality of Life in Alzheimer's Disease (QoL-AD, proxy version)
Time frame: General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
The QoL-AD proxy version assesses perceived quality of life in people with cognitive impairment through the judgement of a caregiver, professional or informant who knows the participant well. It includes 13 items, each scored on a 4-point scale: 1 means poor, 2 means fair, 3 means good and 4 means excellent. The total score is obtained by adding the 13 item scores, giving a possible range from 13 to 52 points. Higher scores indicate better perceived quality of life.
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 14 Sep 2026.
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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.
Cristina García Bravo, PhD study chair
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogames masterclass and Therapy with videogames in people with Older Adults (65 Years and Older) and Cognitive Impairment, Mild, run by Golden Gamers Go SL 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 1 inclusion and 1 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 14 Sep 2026. 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?
Montreal Cognitive Assessment (MoCA) (time frame: General perception of the person's cognitive sphere (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.