An interventional study of Resilience training and cognitive training in Healthy Aging, Cognitive Change and Psychological Stress, sponsored by Toronto Metropolitan University. Recruiting at 1 site in Canada. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Health services research
The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).
The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.
In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.
Objectives:
Sample:
For Study 1, the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants (aged 60+, Chinese migrants) through WeChat(a popular instant messaging app among Chinese)/email/lab website social media channels (e.g., Facebook, Twitter) from the community partners (see a list attached). For Study 2, we will recruit 120 English-speaking healthy White Canadian older adults (aged 60+) through TMSPSS (the senior participant pool at Toronto Metropolitan University) or advertisements.
Overall Design and Procedure:
Informed consent will be collected. The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities. In Phase 1 (pretest), the investigators will administer a large battery of outcome measures including physical, psychological (emotional and cognitive), and social function measures to assess the baseline performance. The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada. In Phase 2 (intervention), participants will be randomly assigned to an "active aging with resilience", an "active aging", and a "workshop" control condition. They will go through 4 weeks of 8 sessions of training/control treatment delivered virtually through Zoom/YouTube and 8 sessions of offline self-practice. In Phase 3 (posttest), all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session. Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs.
Intervention:
The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active.
During the 4-week training period delivered through Zoom/YouTube, participants in the "active aging with resilience" group will complete 8 sessions (approximately 1.5 hours per session and 2 sessions per week) of active aging training program integrated with a resilience-building module. Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters (e.g., gratitude, forgiveness, grit etc.). This will be followed by the 1-hour multi-dimensional active aging training activities, including progressive "aging in motion" physical and nutrition training (e.g., age-appropriate "Choose to move" physical workout on-line videos), cognitive training with executive function and speed based on a customized module on CogniFit website, socialization and social engagement (e.g., discussion on the topic and session, followed by homework on volunteering, calling friends/families, community activity participation etc.), and combined bio-psycho-social multi-component training (e.g., performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting). Participants in the "active aging" group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards. Both the "active aging with resilience" and traditional "active aging" group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules. Finally, participants in the receptive "workshop" control group will attend 8 virtual workshops or watching workshop videos (following the same 4-week schedule as the two training groups) on different aging-related topics such as physical health, mental health, cognitive wellbeing, emotional regulation, social engagement, and resilience. Each workshop will take approximately 1.5 hours (including 30 min for questions). They will also review and watch the replays of last workshops and take a short survey question after each review session. All these activities will be delivered virtually via Zoom/YouTube in groups of 10-15 individuals.
Data Analysis Plan To identify active aging and resilience predictors, a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session, with all sociodemographic as predictors and outcome measure performance as dependent variables. To evaluate the relative efficacy of the active aging intervention programs, a 3 (condition) by 2 (session) mixed model analysis of variances (ANOVA) models will be conducted on each outcome variable, after controlling for potential sociodemographic covariates. For comparison and clarity purposes, if the outcome measures within each function domain demonstrates similar patterns, the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain. This composite score will be used as the outcome variable in the ANOVA. In light of the literature, the investigators hypothesized that the "active aging with resilience" training will produce larger and wider benefits relative to the "active aging" training, both compared against the receptive "workshop" control condition.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 240 is above the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Toronto Metropolitan University is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
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Study 1(Chinese group):
Study 2(Canadian group):
Exclusion Criteria:
In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 15-min resilience-building module.
Behavioral: Resilience training · Behavioral: cognitive training · Behavioral: physical exercise · Behavioral: social interaction
The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module, which will be replaced by watching 15 minutes of educational video on topics such as health, nature or travel.
Behavioral: cognitive training · Behavioral: physical exercise · Behavioral: social interaction
The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.
Behavioral: workshop series
Receive mini course on what is resilience and how to use different exercises to be more resilient in life.
Play games that trains attention, memory and planning using the services provided by CogniFit.
Engage in age-appropriate physical exercises.
Engage in social discussion with peers in the group.
Watch a series of workshops targeting the older adult population.
Exercise Self-efficacy level (ESES)
(out of 40) higher score means better self-efficacy at carrying out regular physical activities and exercise.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
the 5-item World Health Organization WellBeing Index (WHO-5)
(out of 25) higher score indicates better overall self-perception of wellbeing in the past 2 weeks
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Kessler Psychological Distress Scale (K10)
(out of 50) higher score indicates worse overall mental health
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Multidimensional Scale of Perceived Social Support (MSPSS)
(out of 7) higher score indicates higher levels of self-precepted social support
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Conner-Davidson Resilience Scale 10-item (CD RISC-10)
(out of 40) higher score indicates higher resilience in face of difficulty in life.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Emotional regulation Questionnaire (ERQ)
Cognitive reappraisal (out of 42) and expressive suppression (out of 28). Higher score indicates higher inclination to use this facet to control their emotions.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Positive and Negative Affect Schedule (PANAS)
Positive affect (out of 50) and negative affect (out of 50). Higher score indicates feelings of higher levels of the positive/negative affect at the moment.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Visual working memory test
Assessed using computerized games from CogniFit. Higher score indicates better visual short-term memory and memory span.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Divided attention test
Assessed using computerized games from CogniFit. Higher score indicates better ability to divide attention between two competing tasks.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Visual memory test
Assessed using computerized games from CogniFit. Higher score indicates better ability to memorize and recognize shapes and sequence order of visual object.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Stroop test
Assessed using computerized games from CogniFit. Higher score indicates better ability to inhibit irrelevant information in tasks.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Sustained attention to response test
Assessed using computerized games from CogniFit. Higher score indicates better ability to sustain attention to show rapid response to targets when present.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Satisfaction with life scale (SWLS)
(out of 35) higher score indicates higher self-perception of life satisfaction
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Instrumental Activities of Daily Living(IADL)
(out of 8) higher score indicates better ability to carry out daily physical activity
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The 6-item De Jong Gierveld Loneliness Scale
(out of 30) higher score indicates higher levels of loneliness
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The Brief Approach/Avoidance Coping Questionnaire (BACQ)
approach (out of 30) and avoidance (out of 30) scores. Higher score in each category indicates their inclination to act in relation to problems and illness.
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
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