Clinical trial NCT03867474: Mindfulness-Based Stress Reduction With Older Adults Living With Cognitive Impairment in Primary Care.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feasibility Randomized Control Trial
Keywords: Mindfulness, Primary Care, MBSR, Cognitive Impairment
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2019-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 60 years
* English fluency
* living independently in the community
* self-reported demographic information that includes either the label of SCD or MCI

Exclusion Criteria:

* history of prior participation in any MBSR or other mindfulness-based interventions, or participation in regular (weekly) mindfulness or yoga practice
* low mood as indicated by a 5 or greater on the Geriatric Depression Scale (GDS)
* alcoholism and/or other substance abuse defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) (American Psychiatric Association, 2013
* Montreal Cognitive Assessment (MoCA) of 23 (+/- 4) or under; and
* if participating in other concurrent group(s) e.g. cognitive behavioural therapy (CBT) or memory training programs in the community, while in the study.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 30 mins
Secondary outcomes:
measure: Geriatric Anxiety Inventory (GAI)
timeFrame: 10-15 minutes
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 10-15 minutes
measure: Perceived Stress Scale (PSS)
timeFrame: 10 minutes
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: 5-10 minutes
measure: Quality-of-Life-Alzheimer's Disease (QoL-AD)
timeFrame: 5-10 minutes
measure: Acceptance and Action Questionnaire (AAQ)
timeFrame: 5-10 minutes
Other outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 10-15 minutes
measure: Geriatric Depression Scale (GDS)
timeFrame: 10 minutes
Locations:
city: Toronto
country: Canada
facility: Womens College Hospital, Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
References:
citation: Tran T, Donnelly C, Nalder EJ, Trothen T, Finlayson M. Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol. BMJ Open. 2020 Jun 23;10(6):e035299. doi: 10.1136/bmjopen-2019-035299.