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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Mindfulness Training for Older Adult Canadian Immigrants

Clinicaltrials.gov identifier NCT03923452

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted April 23, 2019

Study Description

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:Stress
  • Intervention/Treatment: Behavioral: Mindfulness-based Stress Reduction
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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)
  • Primary Purpose: Prevention
  • Official Title: Mindfulness Training for Low-Income Older Adult Canadian Immigrants
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
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.
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts

Contact: Alexandra J Fiocco, PhD 416-979-5000 ext 3008 afiocco@psych.ryerson.ca

Locations
Sponsors and Collaborators

Ryerson University

More Information
  • Responsible Party: Ryerson University
  • ClinicalTrials.gov 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ryerson University: wellbeing
    mindfulness
    immigrant
    stress