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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03923452
Other study ID # AFiocco
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date April 30, 2023

Study information

Verified date April 2024
Source Toronto Metropolitan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, self-compassion, emotion regulations, 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. Due to COVID-19, all sessions will be held virtually.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Toronto Metropolitan University (formerly Ryerson University) Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Difficulties in Emotion Regulation Scale (DERS-16) A 16-item Likert-type scale that measure the propensity for emotion regulation. Higher scores indicate greater emotion regulation. 2 days (pre-post testing)
Other Mindful Self-Care Scale- SHORT (MSCS) 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. 2 days (pre-post testing)
Other Stroop Task A 15-minute computer-based task that measures attention and inhibition. 2 days (pre-post testing)
Other Self-Compassion Scale (SCS) A 26-item Likert-type scale (Almost Never to Almost Always) that measures self-compassion. Greater scores indicate greater self-compassion. 2 days (pre-post testing)
Other Brief Resilience Scale (BRS) 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. 2 days (pre-post testing)
Primary Perceived Stress Scale (PSS) 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 days (pre-post testing)
Primary Center for epidemiological studies - depression (CES-D) 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. 2 days (pre-post testing)
Secondary Five Facet Mindfulness Questionnaire (FFMQ) 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. 2 days (pre-post testing)
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