NCT03923452

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
3.2 years until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 18, 2025

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

April 18, 2019

Last Update Submit

June 15, 2025

Conditions

Keywords

mindfulnessimmigrantstresswellbeing

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • Five Facet Mindfulness Questionnaire (FFMQ)

    2 days (pre-post testing)

Other Outcomes (5)

  • Difficulties in Emotion Regulation Scale (DERS-16)

    2 days (pre-post testing)

  • Mindful Self-Care Scale- SHORT (MSCS)

    2 days (pre-post testing)

  • Stroop Task

    2 days (pre-post testing)

  • +2 more other outcomes

Study Arms (2)

MBSR: Mindfulness-based stress reduction

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Stress Reduction

WLC: Wait list Control

NO INTERVENTION

Participants will be asked to log their self-care activities every week.

Interventions

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.

MBSR: Mindfulness-based stress reduction

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years of age; Canadian immigrant; low socioeconomic status; immigrated to Canada within last 15 years; reports experiencing stress in their daily life.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Metropolitan University (formerly Ryerson University)

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alexandra J Fiocco, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researcher who engage in pre-post testing assessment will be blinded to participant allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized block design: 25 randomized to experimental group; 25 randomized to control group in blocks of 8
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 22, 2019

Study Start

June 30, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

June 18, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

de-identified quantitative data will be posted on an open science framework when published in an open access journal. Data will also be made available upon request under ethical guidance.

Locations