Clinical trial NCT04982497: Development and Evaluation of a Psychological Intervention in Videogame Format for the Promotion of Active Aging
Official title: Development and Evaluation of a Psychological Intervention in Videogame Format for the Promotion of Active Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Aging Problems
Keywords: video game
older adults
active aging
health promotion
study protocol
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: State Research Agency, Spain
First posted: 2021-07-29
Enrollment: 548
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary outcomes:
measure: Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow- ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
measure: Dropouts and treatment adherence
timeFrame: During the intervention sessions (8 weeks)
measure: Satisfaction with the service received
timeFrame: Post-intervention (9 weeks)
Other outcomes:
measure: Socio-demographic characteristics
timeFrame: Pre-intervention
measure: Cognitive function
timeFrame: Screening
measure: Diagnostic Interview
timeFrame: Screening
Locations:
city: Santiago de Compostela
country: Spain
facility: Research Group on Mental Health and Psychopatology
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Fernando L. Vázquez González, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santiago de Compostela
name: Ángela J. Torres Iglesias, PhD.
role: PRINCIPAL_INVESTIGATOR
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