Stress Clinical Trial
— MTCIOfficial title:
Mindfulness Training for Low-Income Older Adult Canadian Immigrants
| 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 |
| Verified date | April 2024 |
| Source | Toronto Metropolitan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Metropolitan University (formerly Ryerson University) | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Toronto Metropolitan University |
Canada,
| 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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