Feasibility Randomized Control TrialNCT03867474
Mindfulness-Based Stress Reduction With Older Adults Living With Cognitive Impairment in Primary Care.
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Feasibility Randomized Control Trial, run by Women's College Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility Randomized Control Trial
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Oct 2019to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 60 years
- English fluency
- living independently in the community
- self-reported demographic information that includes either the label of SCD or MCI
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Womens College Hospital, Family Health Team
Toronto, Ontario, M4Y 2V6
Todd D Tran, 4163015881, Todd.Tran@wchospital.ca
- Not yet recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Todd D Tran, PhD (cand), 4163015881, todd.tran@wchospital.ca
Ken Callaghan, MBA, 416-323-6400 ext. Tran, toddtran88@gmail.com
About this study
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.
Read the 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.
- Conditions
- Feasibility Randomized Control Trial
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness, Primary Care, MBSR, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention (MBSR) | Experimental | Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Control - Usual Care | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 mins
Secondary outcomes (6)
Geriatric Anxiety Inventory (GAI)
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
Measured: 10-15 minutes
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).
Measured: 10-15 minutes
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
Measured: 10 minutes
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).
Measured: 5-10 minutes
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).
Measured: 5-10 minutes
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)
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start3 Oct 2019
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feasibility Randomized Control TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Principal investigator, Todd Tran, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867474
- Sponsor's protocol ID
- 2017-0056-E
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unsure at the present moment
Publications
Tran T, Donnelly C, Nalder E, Trothen T, Finlayson M. Mindfulness-based stress reduction for community-dwelling older adults with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) in primary care: a mixed-methods feasibility randomized control trial. BMC Prim Care. 2023 Feb 9;24(1):44. doi: 10.1186/s12875-023-02002-y.
PubMed 36759766Tran 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.
PubMed 32580984
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03867474
- Acronym / sponsor ID
- 2017-0056-E
- Conditions
- Feasibility Randomized Control Trial
- Keywords
- Mindfulness, Primary Care, MBSR, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention (MBSR) | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm |
| Control - Usual Care | No intervention | –Control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 60 years
- English fluency
- living independently in the community
- self-reported demographic information that includes either the label of SCD or MCI
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Intervention (MBSR) |
Primary outcome
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
6 secondary outcomes
Geriatric Anxiety Inventory (GAI)
Time frame: 10-15 minutes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 10-15 minutes
Perceived Stress Scale (PSS)
Time frame: 10 minutes
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: 5-10 minutes
Quality-of-Life-Alzheimer's Disease (QoL-AD)
Time frame: 5-10 minutes
Acceptance and Action Questionnaire (AAQ)
Time frame: 5-10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 36759766Tran T, Donnelly C, Nalder E, Trothen T, Finlayson M. Mindfulness-based stress reduction for community-dwelling older adults with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) in primary care: a mixed-methods feasibility randomized control trial. BMC Prim Care. 2023 Feb 9;24(1):44. doi: 10.1186/s12875-023-02002-y.
- Derived from this study: PubMed 32580984Tran 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.
- Individual participant dataSharing planned: No. Unsure at the present moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Feasibility Randomized Control Trial, run by Women's College Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: 30 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.