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

Aging Clinical Trial

— GAMEPROAGING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982497
• Other study ID #: PID2019-105052RB-I00
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: University of Santiago de Compostela
• Contact: Fernando L. Vázquez González, PhD.
• Phone: (00 34) 881811000
• Email: fernandolino.vazquez[@]usc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 574 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 574
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Aging Problems

Intervention

Behavioral:
• Video game based intervention
The intervention will be administered via an online graphic-adventure video game. It includes 3 components: depression prevention, cognitive stimulation, and healthy habits promotion. The depression prevention component will be adapted from an indicated prevention program based on the model by Lewinsohn et al. (1985). The cognitive stimulation component is based on cognitive reserve (Tucker & Stern, 2011) and neuroplasticity (Shapiro, 2001), the cognitive stimulation model by Spector et al. (2006), and the causes of age-related memory failures (Light, 1991) (e.g., decrease in the processing resources, semantic coding deficit, difficulties in deliberate information retrieval). The healthy habits promotion component is based on the social learning and social cognitive theories (Bandura, 1986; Spiegler, 2016).

Other:
• Control group
The active control group will have access to a platform of online therapeutically inactive information related to active aging.

Locations

Country	Name	City	State
Spain	Research Group on Mental Health and Psychopatology	Santiago de Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Agencia Estatal de Investigación, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-demographic characteristics	Sociodemographic characteristics will be collected through a questionnaire elaborated ad hoc for this study. Participant data will include sex, age, marital status, level of education, main occupation and family monthly income per household.	Pre-intervention
Other	Cognitive function	Cognitive function will be assessed with the Mini-mental State Examination (MMSE; Folstein et al., 1975; Spanish version by Lobo et al., 1999). This 30-item instrument is used extensively in clinical and research settings to measure cognitive impairment. It has norms adjusted for age and education, good reliability values, and a sensitivity of 89.8% and specificity of 75.1%.	Screening
Other	Diagnostic Interview	For the diagnostic interview, the Mini International Neuropsychiatric Interview (M.I.N.I.; Sheehan et al., 1998; Spanish version by Ferrando et al., 2000) will be used. This diagnostic interview with 120 items explores the main mental disorders of Axis I of the Diagnostic and Statistical Manual (DSM-IV) or International Classification Diseases (ICD-10) and must be applied by a clinician. It has adequate reliability (k = 0.50-0.90), a sensitivity between 17%-92% and specificity of 75%-100%.	Screening
Primary	Change from baseline Health Status to post-treatment (9 weeks), and 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.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	This will be measured with the General Health Questionnaire (GHQ-12; Goldberg & Williams,1988; Spanish version by Rocha et al., 2011). This self-administered questionnaire consists of 12 items and assesses emotional distress. The person evaluates each item based on their emotional distress using a Likert scale with four response options ranging from "better than usual" to "much worse than usual," which are scored using a bimodal response scale (0, 0, 1, 1). The total score ranges from 0 to 12, with higher scores indicating greater emotional distress. The internal consistency (Cronbach's alpha) is .86 for people under 65 and .90 for people 65 and older.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977; Spanish version by Vázquez et al., 2007). This 20- item scale is self-administered and assesses depressive symptoms. The person evaluates each item based on how often they have experienced it in the last week using a Likert scale with four response options ranging from 0 (rarely or none of the time) to 3 (most of the time). The total score ranges from 0 to 60, where higher scores correspond to greater depressive symptomatology. Internal consistency (Cronbach's alpha) of the scale is .89.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	To evaluate the reinforcement, we will use the Environmental Reward Observation Scale (EROS; Armento & Hopko, 2007; Spanish version by Barraca & Pérez-Álvarez, 2010). It is a self-administered 10-item scale that assesses the degree of positive reinforcement contingent on the response received from the media. Each item is evaluated based on the degree to which the individual believes applies to them, according to a Likert scale with four response options ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 10 to 40, with higher scores indicating more positive reinforcement. The internal consistency (Cronbach's alpha) of the Spanish version is .86.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow- ups at 3, 6 and 12 months	The occurrence of automatic negative thoughts will be assessed through the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980; Spanish version by Otero et al., 2017). This is a 30-item self-report questionnaire that assesses negative thoughts. The subject must indicate the frequency for which a number of thoughts have suddenly arisen in their mind over the last week on a five-point scale from 1 (never) to 5 (always). Scores range between 30 and 150, with a higher score indicating more negative thoughts experienced by the subject. The ATQ's internal consistency (Cronbach's alpha) is .96.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Self-reported memory will be measured with the Multifactorial Memory Questionnaire (MMQ; Troyer & Rich, 2002). This 57-item self-administered test assesses subjective memory. Items are rated on a 5-point Likert scale based on the test taker's experiences over the previous two weeks. It comprises three dimensions: Contentment, Ability, and Strategy. Contentment measures satisfaction, concern, and overall appraisal of one's own memory; the score ranges from 0 to 72, with higher scores indicating greater satisfaction. The internal consistency is .95. Ability measures self-perception of everyday memory ability; the score range is 0 to 80, with higher scores indicating better self-reported memory ability, with an internal consistency of .93. Strategy measures the use of practical memory strategies in day-to-day life; the score range is 0 to 76, with higher scores indicating greater use of memory strategies. The internal consistency is .83.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Participants' sleep hygiene behaviors will be assessed with the Sleep Hygiene Index (SHI; Mastin et al., 2006). It is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). The total score ranges from 0 to 52, with a higher score representing poorer sleep hygiene. Its internal consistency (Cronbach's alpha) is .66.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Participants' physical activity will be assessed with the Brief Physical Activity Assessment Tool (BPAAT; Marshall et al., 2005; Spanish version by Puig et al., 2012). This two-item questionnaire measures the frequency and duration of moderate and vigorous physical activity in an individual's usual week. Combining the results of both questions, scores can range from 0 to 8, with a higher score indicating higher physical activity. In addition, the subject can be classified as sufficiently (=4 score) or insufficiently active (0-3 score). The questionnaire has good test-retest reliability and content validity.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Eating habits will be assessed with the Rapid Eating and Activity Assessment for Participants-Shortened Version (REAP-S; Segal-Isaacson et al., 2004 ). This 16-item scale assesses the consumption of different food groups. The total score ranges from 13 to 39, with a higher score representing better eating habits. This instrument has shown good convergent validity with the Block Semi Quantitative Food Frequency Questionnaire (Block, 1998), and is based on the Dietary Guidelines of the U.S. Department of Health and Human Services (Office of Disease Prevention and Health Promotion, 2015 ) and the Healthy People 2010 objectives (U.S.Department of Health and Human Services, 2000 ).	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	The Body Mass Index (BMI) is a measure of nutritional status in adults. It is defined as an individual's weight in kilograms divided by the square of the height in meters (kg/m2) and classifies nutritional status as underweight, normal weight, pre-obesity, and obesity (I, II, and III).	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 3, 6 and 12 months	Social support will be assessed with the Duke-UNC Functional Social Support Questionnaire (Duke-UNC-11; Broadhead et al., 1988 ; Spanish version by Bellón et al., 1996). This self-report 11-item test assesses perceived social support. Each item is rated on a 5-point scale ranging from 1 (never) to 5 (always). The total score ranges from 11 to 55, with a higher score representing more social support. Its internal consistency (Cronbach's alpha) is .90.	Pre- and post-intervention (9 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Dropouts and treatment adherence	Dropouts will be assessed by means of a register throughout the study. Treatment adherence will be automatically registered using both the online video game and the App by means of the number of modules completed by each participant, the time played, the time spent on cognitive tasks throughout the game and between session homework accomplishment.	During the intervention sessions (8 weeks)
Secondary	Satisfaction with the service received	Participant satisfaction with the service received will be evaluated upon intervention completion. We will use the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979; Spanish version by Vázquez et al., 2017). It is a 8-item scale with 4 possible answers and a final ranking score ranging from 8 to 32, where a higher score implies greater satisfaction with the service received. It has an internal consistency of .80.	Post-intervention (9 weeks)