Feasibility Randomized Control Trial Clinical Trial
Official title:
Mixed-methods, Feasibility Randomized Control Trial of Mindfulness-Based Stress Reduction (MBSR) With Older Adults Living With Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI): a Primary Care Context
People living with subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
experience less efficiency in performing complex everyday tasks, which may result in a
general sense of discontentment and decreased satisfaction with their overall functional
performance. Additionally, SCD and MCI have been associated with concomitant anxiety,
depressive mood, perceived stress, a decrease in emotional well-being and quality-of-life
(QoL) among community-dwelling older adults. These concomitant psychosocial issues may result
in emotional distress which further exacerbates cognitive decline.
At the present time, there is a lack of evidence that supports pharmacologic interventions to
ameliorate concomitant psychosocial issues with this particular population due to medication
side-effects, drug-drug interaction and polypharmacy. Consequently, exploring alternative
non-pharmacological interventions to assist in ameliorating psychosocial issues is an
important consideration. Secondly, evaluating perceived satisfaction on functional
performance with those living with SCD and MCI, and assessing interventions that may support
this is also worthwhile to pursue. Primary care providers are often the first point of
contact when older adults and their families become concerned about memory problems. Health
care professionals, on an interdisciplinary Family Health Team (FHT), such as occupational
therapists, are well-positioned to holistically address both the psychosocial and functional
needs in a client/family centred way with this growing population in primary care. The study
proposes to offer a Mindfulness-Based Stress Reduction (MBSR) program, which is an 8-week
program that has been shown to be beneficial in alleviating emotional distress among adults
living with physical and psychological issues in the general population.
Purpose: The overarching purpose of this study is to determine whether MBSR is appropriate
for a larger clinical trial. AIM 1: To explore the feasibility of conducting a randomized
control trial (RCT) of an occupational therapist-led, 8-week MBSR program in an
interprofessional primary care setting, with the following objectives: 1a. To assess
participant recruitment, intervention adherence, and study retention, 1b. To explore the
acceptability of delivering technology-based tablets (iPads) for intervention, and data
collection in the MBSR program and 1c. To explore the perspectives of participants and
healthcare providers with respect to satisfaction (e.g. the intervention and its delivery),
perceived value, barriers to and facilitators of acceptability of this 8-week MBSR program in
primary care.
AIM 2: To evaluate the impact of MBSR on satisfaction with functional performance and
psychosocial outcomes in individuals with SCD or MCI with the following objectives: 2a. To
determine the effect sizes of satisfaction with functional performance and psychosocial
outcomes Methods: A convergent mixed-methods, feasibility randomized control trial will be
used. Participants will be randomized into an 8-week intervention or control group (usual
care) and these groups will be compared at three different time points. Initially, data
analysis will involve collecting and analyzing the quantitative and qualitative strands
separately. Both qualitative and quantitative data will then be merged for comparative
analysis to best understand both the feasibility of a larger clinical trial and to explore
preliminary clinical outcomes from the study.
Significance: The results gained from this study will help to determine the feasibility of
pursuing a future fully powered trial. Ultimately, this line of research will determine if
there are potential benefits of MBSR in improving perceived satisfaction of functional
performance and alleviating concomitant psychosocial issues that is associated with those
living with SCD and MCI.
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