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Mindfulness Training for Older Adult Canadian Immigrants (MTCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03923452
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):
Alexandra J. Fiocco, PhD, Ryerson University

Brief Summary:
This study will evaluate whether mindfulness-based stress reduction (MBSR) is a viable community program for enhancing wellbeing among older adult immigrants from low income neighborhoods. Half of the sample will be randomized to receive the 9-week mindfulness program and the other half will be randomized to a wait list control condition. Primary outcomes of interest will include perceived stress and self-report depressive symptoms. Secondary outcomes will include trait mindfulness and self-care, optimism, expectations regarding aging, social connection, and attentional skills. Participants will also be invited to engage in a 30-minute interview to discuss their lived experience as an immigrant in Canada and their experience in the MBSR program.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Mindfulness-based Stress Reduction Not Applicable

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 2012,4 the highest chronic 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.

Within the one-year tenure of the RBC grant, 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, social engagement, quality of life, and self-reported emotional health. It is hypothesized that mindfulness training will enhance indices of wellbeing compared with 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 living with economic insecurity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized block design: 25 randomized to experimental group; 25 randomized to control group in blocks of 8
Masking: Single (Outcomes Assessor)
Masking Description: Researcher who engage in pre-post testing assessment will be blinded to participant allocation.
Primary Purpose: Prevention
Official Title: Mindfulness Training for Low-Income Older Adult Canadian Immigrants
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : December 30, 2020

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.
Behavioral: Mindfulness-based Stress Reduction
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.

No Intervention: WLC: Wait list Control
Participants will be asked to log their self-care activities every week.

Primary Outcome Measures :
  1. 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.

  2. Center for epidemiological studies - depression (CES-D) [ Time Frame: 2 days (pre-post testing) ]
    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.

Secondary Outcome Measures :
  1. Short Form (36) Health Survey (SF-36) [ Time Frame: current2 days (pre-post testing) ]
    The SF-36 is a 36-item instrument that measures physical, emotional, and overall health. The scale contains 8 parameters of health status: physical functioning, role limitation due to physical and emotional problems, social functioning, mental health, pain, vitality, and general health perception. Items are aggregated to create two component scores: physical and mental component summary scores, with higher scores indicating better subjective health. The scoring and score transformation will be done via the QualityMetric's Health Outcomes™ Scoring Software.

  2. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 2 days (pre-post testing) ]
    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.

Other Outcome Measures:
  1. UCLA Loneliness Scale [ Time Frame: 2 days (pre-post testing) ]
    UCLA-LS is a 20-item self-report measure to assess feelings of loneliness and social isolation. Total scores can range from 20 to 80, with higher scored indicated greater perceived loneliness and social isolation.

  2. Life Orientation Test-Revised (LOT-R) [ Time Frame: 2 days (pre-post testing) ]
    LOT-R is a 6-item questionnaire that measures the degree to which an individual endorses an optimistic vs. pessimistic view point. Participants rate the extent to which they agree with each item on a five-point Likert-type scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater degree of optimism.

  3. Quality of Life Scale (QOLS) [ Time Frame: 2 days (pre-post testing) ]
    The QOLS is a 16-item measure that assesses whether needs are met with satisfaction. Specifically, the QOLS measures quality of six life domains: physical and material well-being, relationships with other people, social and civic activities, personal development, and independence. Each item is rated on a 7-point Likert-type scale, ranging from 1 (Terrible) to 7 (Delighted). Total score ranges from 16 to 112. Higher scores indicated individuals are more satisfied with their needs being met, and better quality of life.

  4. Expectations Regarding Aging (ERA) [ Time Frame: 2 days (pre-post testing) ]
    The ERA is a 38-item questionnaire that measures beliefs about aging. Responses are reported on a four-point Likert scale from "strongly agree" to "strongly disagree" which is computed into a range scale from 0 to 100 for each ERA subset and overall score. Higher scores indicate more positive ERA.

  5. Stroop Task [ Time Frame: 2 days (pre-post testing) ]
    A 15-minute computer-based task that measures attention and inhibition

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 60+ years of age; Canadian immigrant; low socioeconomic status

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03923452

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Contact: Alexandra J Fiocco, PhD 416-979-5000 ext 3008

Sponsors and Collaborators
Ryerson University

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Responsible Party: Alexandra J. Fiocco, PhD, Associate Professor, Ryerson University Identifier: NCT03923452     History of Changes
Other Study ID Numbers: AFiocco
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: de-identified data will be made available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandra J. Fiocco, PhD, Ryerson University: