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

U

University of Santiago de Compostela

Status

Completed

Conditions

Aging
Aging Problems

Treatments

Behavioral: Video game based intervention
Other: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT04982497
PID2019-105052RB-I00

Details and patient eligibility

About

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.

Enrollment

548 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

548 participants in 2 patient groups

Video game based intervention
Experimental group
Description:
The participants in the experimental group will receive a cognitive-behavioral intervention for active aging via an interactive online multimedia video game with a complementary App. The intervention will consist of 8 modules each approximately 70 (±25) minutes long that will be administered at a rate of 1 per week with between-session homework.
Treatment:
Behavioral: Video game based intervention
Control group
Active Comparator group
Description:
Individuals assigned to this group will receive online therapeutically inactive information about active aging.
Treatment:
Other: Control group

Trial contacts and locations

1

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Central trial contact

Fernando L. Vázquez González, PhD.

Data sourced from clinicaltrials.gov

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