Aging Clinical Trial
— GAMAPEAOfficial title:
Gaming Applied to the Promotion of Active Aging
Verified date | March 2020 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Active aging programs have been recommended by the World Health Organization to help deal
with the progressive aging of the population. However, older adults have difficulties in
accessing these programs. Online video game-based interventions would improve their
accessibility, while complementing these interventions with a mobile application (App) would
increase adherence and professional monitoring. The main objective of this study is to assess
the efficacy of an interactive, online, video game-based cognitive behavioral intervention
with an App companion for active aging compared to a control group receiving therapeutically
inactive information. The secondary objectives are to: (a) analyze the moderators of the
change in the outcome variables and (b) evaluate adherence to the intervention.
A randomized controlled trial will be performed including healthy adults older than 44.
Recruitment of 180 participants is planned, with random allocation to one of the two
conditions (90 participants per group): (a) an experimental group receiving an interactive,
online, multimedia, video game-based cognitive behavioral intervention with an App companion
(CCI-V) or (b) a control group receiving online therapeutically inactive information about
active aging (CG).
The intervention will be administered in 8 weekly modules comprised of 45-minute sessions. A
blind evaluation will be conducted through online self-administered tests at baseline,
post-intervention, and 6- and 12-month follow-up. The primary outcome will be the health
status. Secondary outcomes will be emotional well-being, symptoms of depression,
reinforcement, negative thoughts, self-reported memory, cognitive tasks, sleep hygiene,
physical activity, eating habits, body mass index (BMI), social support, dropouts, treatment
adherence, and satisfaction with the intervention.
Status | Completed |
Enrollment | 180 |
Est. completion date | December 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - adult older than 44 years old living in the Region of Galicia (Spain) - accessibility to a personal computer and a smartphone with internet connection - informed consent to participate in the study - commitment to conduct the program and complete subsequent evaluations Exclusion Criteria: - serious neurological or mental disorder (depressive disorder, schizophrenia, bipolar disorder, major neurocognitive disorder, dissociative disorders, substance abuse and/or dependence) - physical or psychological problems that prevent study implementation (e.g., severe auditory and/or visual loss) - recent psychological or psychiatric treatment (in the past 2 months) - participation in another trial |
Country | Name | City | State |
---|---|---|---|
Spain | Research Group on Mental Health and Psychopatology | Santiago De Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela | Center for Industrial Technological Development of Spain, European Regional Development Fund |
Spain,
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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, family monthly income per household, level of education, and main occupation. | Pre-intervention | |
Other | Cognitive function | Cognitive function will be assessed with the Mini-mental State Examination [MMSE]. 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.] will be used. This diagnostic interview 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 validity and reliability. | Screening | |
Primary | Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Health status will be measured with the 36-Item Short-Form Health Survey [SF-36]. 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 6 and 12 months | |
Secondary | Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 6 and 12 months | This will be measured with the General Health Questionnaire [GHQ-12]. 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 6 and 12 months | |
Secondary | Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale [CES-D]. 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 6 and 12 months | |
Secondary | Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 6 and 12 months | To evaluate the reinforcement, we will use the Environmental Reward Observation Scale [EROS]. 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 6 and 12 months | |
Secondary | Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow-ups at 6 and 12 months | The occurrence of automatic negative thoughts will be assessed through the Automatic Thoughts Questionnaire [ATQ]. 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 6 and 12 months | |
Secondary | Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Self-reported memory will be measured with the Multifactorial Memory Questionnaire [MMQ]. 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 6 and 12 months | |
Secondary | Cognitive tasks | The number of cognitive tasks completed during the video game will be counted and registered. | During the intervention sessions (8 weeks) | |
Secondary | Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Participants' sleep hygiene behaviors will be assessed with the Sleep Hygiene Index [SHI]. 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 6 and 12 months | |
Secondary | Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Participants' physical activity will be assessed with the Brief Physical Activity Assessment Tool [BPAAT]. 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 6 and 12 months | |
Secondary | Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Eating habits will be assessed with the Rapid Eating and Activity Assessment for Participants-Shortened Version [REAP-S]. 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 and is based on the Dietary Guidelines of the U.S. Department of Health and Human Services (Office of Disease Prevention and Health Promotion) and the Healthy People 2010 objectives. | Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months | |
Secondary | Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 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 6 and 12 months | |
Secondary | Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 6 and 12 months | Social support will be assessed with the Duke-UNC Functional Social Support Questionnaire [Duke-UNC-11]. 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 6 and 12 months | |
Secondary | Drop outs and treatment adherence | Dropouts and treatment adherence will be assessed through frequency, duration playing the videogame and between-session homework accomplishment. It will be automatically registered and monitored through the online platform and the App companion. | 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]. 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) |
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