Feasibility Randomized Control Trial of Mindfulness-Based Stress Reduction (MBSR) With Older Adults Living With Cognitive Impairment in Primary Care.

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2019

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.

Interventions

  • Behavioral: Mindfulness-Based Stress Reduction (MBSR)
    • The intervention group will be delivered in a group-based format, for one three-hour session per week for an 8-week period. Each session will consist of mindfulness practice (e.g. lying down body scan, sitting meditation, mindful eating, mindful movements such as walking and light hatha yoga movements) along with an inquiry about the practice. Strategies on stress reactivity, responding to stress, and some basic content on cognitive behaviour therapy principles will also be taught. Participants will be placed in dyads during the group. Homework practice will be given to complete on a daily basis for approximately 30-45 minutes. During week six participants will attend an all-day silent meditation retreat on a Saturday (Total of 10 sessions = 8 sessions, 1 orientation, and 1 all-day retreat).

Arms, Groups and Cohorts

  • Experimental: Intervention (MBSR)
    • Mindfulness-Based Stress Reduction (MBSR) – Intervention Arm
  • No Intervention: Control – Usual Care
    • Control

Clinical Trial Outcome Measures

Primary Measures

  • Canadian Occupational Performance Measure (COPM)
    • Time Frame: 30 mins
    • A client-centred semi-structured interview of client’s self-perception of occupational performance issues in the areas of self-care, productivity, and leisure. Five-step process 1. Identification of issues 2. weighting,3. scoring, 4.reassessment and 5. follow-up

Secondary Measures

  • Geriatric Anxiety Inventory (GAI)
    • Time Frame: 10-15 minutes
    • The Geriatric Anxiety Inventory (GAI) consists of 20 “Agree/Disagree” items designed to assess typical common anxiety symptoms.
  • Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: 10-15 minutes
    • The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as “0″ (not at all) to “3″ (nearly every day).
  • Perceived Stress Scale (PSS)
    • Time Frame: 10 minutes
    • Assessment of global appraisal of stress instead of focusing on a particular event. The focus of the question is reporting on the lives of respondents as i. unpredictable ii. uncontrollable or iii. overloaded. It’s a 4-point scale (0-Never and 4-Very Often) with ten questions
  • Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
    • Time Frame: 5-10 minutes
    • A brief measure designed to capture mindfulness in a jargon free and comprehensive way based on Jon Kabat-Zinn’s definition of mindfulness. The 10-questionnaire has a 4-point scale (1 – rarely and 10-Almost Always).
  • Quality-of-Life-Alzheimer’s Disease (QoL-AD)
    • Time Frame: 5-10 minutes
    • The survey has 13-items covering domains (physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole).
  • Acceptance and Action Questionnaire (AAQ)
    • Time Frame: 5-10 minutes
    • To measure psychological flexibility and inflexibility. Experiential avoidance is significantly associated with a wide array of behavioral problems as well as psychopathology (Wolgast, 2014)

Participating in This Clinical Trial

Inclusion Criteria

Inclusion criteria for study participants include: (1) age ≥ 60 years; (2) English fluency; (3) living independently in the community; (4) self-reported demographic information that includes either the label of SCD or MCI

Exclusion Criteria

  • (1) history of prior participation in any MBSR or other mindfulness-based interventions, or participation in regular (weekly) mindfulness or yoga practice; (2) low mood as indicated by a 5 or greater on the Geriatric Depression Scale (GDS) (3) alcoholism and/or other substance abuse defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) (American Psychiatric Association, 2013; Kiefer, Israel, & Martino, 2016); (4) Montreal Cognitive Assessment (MoCA) of 23 (+/- 4) (Clarnette, O'Caoimh, Antony, Svendrovski, & Molloy, 2017; O'Caoimh, Timmons, & Molloy, 2016) or under; and (5) if participating in other concurrent group(s) e.g. cognitive behavioural therapy (CBT) or memory training programs in the community, while in the study.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Women’s College Hospital
  • Collaborator
    • Queen’s University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Todd Tran, Occupational Therapist PhD (candidate) – Women’s College Hospital

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