- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03923452
Mindfulness Training for Older Adult Canadian Immigrants (MTCI)
Mindfulness Training for Low-Income Older Adult Canadian Immigrants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adults aged 65 years and older are the fastest growing segment of the Canadian population. In the 2006 Census, 43% of older adults in Ontario identified as being a Canadian immigrant, a statistic which continues to grow in the context of an aging population. Aging is commonly associated with declines in physical and cognitive capacity, which is significantly accelerated by chronic perceived stress. Lower income older adults are particularly vulnerable to accelerated aging and disease onset due to the stress of economic insecurity. In 2012, the highest low-income rates in Canada were reported among immigrants 65 years of age and older. Accordingly, it is important to investigate programs that can support the wellbeing of aging Canadian immigrants.
The principal investigator (PI) and her research team will conduct a one-factor between-subjects design with two conditions - a mindfulness-based intervention and a waitlist control - to examine the benefits of mindfulness training on indices of wellbeing, including perceived stress, depressive symptoms, emotion regulation, self-compassion and self care. It is hypothesized that mindfulness training will enhance indices of wellbeing compared to a wait-list control. Employing a mixed-methods approach, participants will also engage in a qualitative interviews to provide insight into the lived experience and how mindfulness may serve Canadian immigrants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- Toronto Metropolitan University (formerly Ryerson University)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 60+ years of age; Canadian immigrant; low socioeconomic status; immigrated to Canada within last 15 years; reports experiencing stress in their daily life.
Exclusion Criteria:
- existing contemplative practice; currently enrolled in a research study; non-fluency in English; neurological disorder that prevents participation in the 9-week program or testing procedures; plans to vacation during the study period/unable to attend 9 program sessions and 2 testing sessions; existing substance abuse (last 6 months); psychiatric disorder that may prevent participation in 9-week program or testing procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MBSR: Mindfulness-based stress reduction
Participants will be exposed to the 9-week MBSR program, facilitated by a trained MBSR facilitator.
Due to COVID-19, the program will be held virtually.
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Mindfulness-based stress reduction is a manualized mindfulness training protocol that has been researched for over 20 years.
The original protocol will be used, with the exception of the prescribed home practice duration (i.e. 30 mins of practice).
Rather, the program will be modified to set up participants for success by providing them with instruction to "build" on their meditation practice, beginning with 8 minutes a day.
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No Intervention: WLC: Wait list Control
Participants will be asked to log their self-care activities every week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS)
Time Frame: 2 days (pre-post testing)
|
the PSS is a 14-item questionnaire that measures general perceived stress.
Total Scores range from 0-56, with higher scores denoting greater perceived stress.
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2 days (pre-post testing)
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Center for epidemiological studies - depression (CES-D)
Time Frame: 2 days (pre-post testing)
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The CES-D is a self-report measure of depressive symptoms.
Total score ranges from 0-60, with greater scores denoting greater endorsement of depressive symptoms.
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2 days (pre-post testing)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 2 days (pre-post testing)
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The FFMQ is a 33-item self-report measure, that measures mindfulness characteristics including the ability to observe, describe, act with awareness, non-judging, and non-reacting.
".
Subscale scores range from 8 to 40 for the observing, describing, acting with awareness, and non-judging facets, or 7 to 35 for the non-reacting facet, resulting in an overall FFMQ score range of 39 to 195.
Higher scores indicate greater levels of TM.
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2 days (pre-post testing)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficulties in Emotion Regulation Scale (DERS-16)
Time Frame: 2 days (pre-post testing)
|
A 16-item Likert-type scale that measure the propensity for emotion regulation.
Higher scores indicate greater emotion regulation.
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2 days (pre-post testing)
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Mindful Self-Care Scale- SHORT (MSCS)
Time Frame: 2 days (pre-post testing)
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The Mindful Self-Care Scale- SHORT (MSCS, 2016) is a 33-item scale that measures the self-reported frequency of behaviors that measure self-care behavior.The scale addresses 6 domains of self-care: physical care, supportive relationships, mindful awareness, self-compassion and purpose, mindful relaxation, and supportive structure.
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2 days (pre-post testing)
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Stroop Task
Time Frame: 2 days (pre-post testing)
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A 15-minute computer-based task that measures attention and inhibition.
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2 days (pre-post testing)
|
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Self-Compassion Scale (SCS)
Time Frame: 2 days (pre-post testing)
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A 26-item Likert-type scale (Almost Never to Almost Always) that measures self-compassion.
Greater scores indicate greater self-compassion.
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2 days (pre-post testing)
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Brief Resilience Scale (BRS)
Time Frame: 2 days (pre-post testing)
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A 6-item Likert-type scale (Strongly Disagree to Strongly Agree) that measures resilience when faced with challenge and set-backs.
Higher scores indicate greater resilience.
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2 days (pre-post testing)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra J Fiocco, PhD, Toronto Metropolitan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AFiocco
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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