- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07615647
How Video Game Therapy Affects Thinking and Emotions in Older Adults With Cognitive Impairment
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ALEJANDRO MORILLAS TÉLLEZ, Master
- Phone Number: +34635268124
- Email: goldengamersmanagers@gmail.com
Study Contact Backup
- Name: Gloria Sánchez-Carnerero Casas
- Email: gsccto@gmail.com
Study Locations
-
-
Madrid
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Madrid, Madrid, Spain, 28030
- Recruiting
- Neurovida
-
Contact:
- ALEJANDRO TÉLLEZ
- Phone Number: 635268124
- Email: morillasfhr@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe cognitive impairment with lack of environmental awareness, serious visual limitations that prevent interaction, or any condition causing distress or making participation unsafe.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The experimental group will receive intervention through conventional videogames
|
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. |
|
Active Comparator: Control group
Control group will receive a special talk about the uses of conventional videogames
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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. |
Pre-intervention and post-intervention (up to 1 week)
|
|
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.
|
Pre-intervention and post-intervention (up to 1 week)
|
|
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.
|
General perception of the person's recent overall wellbeing (not session-specific), used at week 0 (baseline) and week 8 (post-intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Cristina García Bravo, PhD, Universidad Rey Juan Carlos
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100220261372026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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