Mindfulness-Based Stress Reduction With Older Adults Living With Cognitive Impairment in Primary Care.
Primary Purpose
Feasibility Randomized Control Trial
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MBSR)
Sponsored by
About this trial
This is an interventional health services research trial for Feasibility Randomized Control Trial focused on measuring Mindfulness, Primary Care, MBSR, Cognitive Impairment
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.
Sites / Locations
- Womens College Hospital, Family Health TeamRecruiting
- Women's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (MBSR)
Control - Usual Care
Arm Description
Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm
Control
Outcomes
Primary Outcome Measures
Canadian Occupational Performance Measure (COPM)
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 Outcome Measures
Geriatric Anxiety Inventory (GAI)
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
Patient Health Questionnaire-9 (PHQ-9)
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)
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)
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)
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)
To measure psychological flexibility and inflexibility.
Experiential avoidance is significantly associated with a wide array of behavioral problems as well as psychopathology (Wolgast, 2014)
Full Information
NCT ID
NCT03867474
First Posted
March 6, 2019
Last Updated
January 31, 2020
Sponsor
Women's College Hospital
Collaborators
Queen's University
1. Study Identification
Unique Protocol Identification Number
NCT03867474
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's College Hospital
Collaborators
Queen's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility Randomized Control Trial
Keywords
Mindfulness, Primary Care, MBSR, Cognitive Impairment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Outcomes Assessor
Masking Description
Enrollment, Randomization and Blinding
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention (MBSR)
Arm Type
Experimental
Arm Description
Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm
Arm Title
Control - Usual Care
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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
Time Frame
30 mins
Secondary Outcome Measure Information:
Title
Geriatric Anxiety Inventory (GAI)
Description
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
Time Frame
10-15 minutes
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
10-15 minutes
Title
Perceived Stress Scale (PSS)
Description
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
Time Frame
10 minutes
Title
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Description
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).
Time Frame
5-10 minutes
Title
Quality-of-Life-Alzheimer's Disease (QoL-AD)
Description
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).
Time Frame
5-10 minutes
Title
Acceptance and Action Questionnaire (AAQ)
Description
To measure psychological flexibility and inflexibility.
Experiential avoidance is significantly associated with a wide array of behavioral problems as well as psychopathology (Wolgast, 2014)
Time Frame
5-10 minutes
Other Pre-specified Outcome Measures:
Title
Montreal Cognitive Assessment (MoCA)
Description
A brief cognitive screening tool to detect MCI
Time Frame
10-15 minutes
Title
Geriatric Depression Scale (GDS)
Description
A brief screening instrument for late-life depression
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Womens College Hospital, Family Health Team
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 2V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd D Tran
Phone
4163015881
Email
Todd.Tran@wchospital.ca
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd D Tran, PhD (cand)
Phone
4163015881
Email
todd.tran@wchospital.ca
First Name & Middle Initial & Last Name & Degree
Ken Callaghan, MBA
Phone
416-323-6400
Ext
Tran
Email
toddtran88@gmail.com
First Name & Middle Initial & Last Name & Degree
Todd D Tran, PhD(cand)
First Name & Middle Initial & Last Name & Degree
Catherine Donnelly, PhD
First Name & Middle Initial & Last Name & Degree
Emily Nalder, PhD
First Name & Middle Initial & Last Name & Degree
Tracy Trothen, PhD
First Name & Middle Initial & Last Name & Degree
Marcia Finlayson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Unsure at the present moment
Citations:
PubMed Identifier
32580984
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.
Results Reference
derived
Learn more about this trial
Mindfulness-Based Stress Reduction With Older Adults Living With Cognitive Impairment in Primary Care.
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