Development and Evaluation of a Psychological Intervention in Videogame Format for the Promotion of Active Aging
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- University of Santiago de Compostela
- Enrollment
- 548
- Locations
- 1
- Primary Endpoint
- Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Fernando Lino Vázquez González
Full Professor
University of Santiago de Compostela
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.
Outcomes
Primary Outcomes
Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months
Time Frame: Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Health status will be measured with the 36-Item Short-Form Health Survey \[SF-36\] (SF-36; Ware \& Shebourne, 1992; Spanish version by Alonso et al., 1995 ). 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.
Secondary Outcomes
- Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow- ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Dropouts and treatment adherence(During the intervention sessions (8 weeks))
- Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Satisfaction with the service received(Post-intervention (9 weeks))
- Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)
- Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months(Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months)