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Behavioural Intervention

Mindfulness Meditation (MM) for Caregiver Burden (MCP Trial)

N/A
Recruiting
Led By Alexandra Fiocco, PhD
Research Sponsored by Toronto Metropolitan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50+ years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up
Awards & highlights

MCP Trial Summary

This trial aims to study whether an 8-week mindfulness program can improve the mental well-being, physical health, and cognitive abilities of primary family caregivers of individuals with dementia or related diseases. 232 caregivers

Who is the study for?
This trial is for primary family caregivers aged 50 or older who are caring for someone with dementia or a similar disease. They must speak English fluently and be able to attend all sessions. Caregivers already practicing mindfulness, those with PTSD, substance disorders, psychosis, or without computer/internet access cannot participate.Check my eligibility
What is being tested?
The study tests if an 8-week mindfulness meditation program can reduce stress and improve mood and cognitive function in caregivers compared to psychoeducation and respite care. Participants will be randomly assigned to one of these three groups and evaluated over a year.See study design
What are the potential side effects?
Mindfulness meditation typically has minimal side effects but may include temporary increases in distress when learning to confront thoughts/emotions. Psychoeducation generally has no significant side effects.

MCP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

MCP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Center for Epidemiological Studies - Depression
Perceived Stress Scale
Secondary outcome measures
Allostatic Load Index
Flanker Task
Zarit Burden Interview
Other outcome measures
Difficulties in Emotion Regulation - Short Form
Fear and Resistance to Mindfulness Scale
Five Factor Mindfulness Questionnaire - Short Form
+4 more

Side effects data

From 2016 Phase 2 trial • 413 Patients • NCT01654289
9%
Musculoskeletal
6%
Cardiac Disorders
5%
General
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exercise
Wait-list Control
Mindfulness Meditation

MCP Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Meditation (MM)Experimental Treatment1 Intervention
8-week mindfulness meditation program is based on Kabat-Zinn's MBSR program and will be led by MBSR-trained facilitators. The program has been modified to make it more accessible to caregivers. Weekly sessions will be 120-minutes long (instead of original 150-180-minute sessions). Formal meditation practices described in the original MBSR program (i.e., body scan, sitting meditation, mindful movement, mindful eating and walking) will be taught, in addition to loving kindness meditation (LKM). Participants will be given guided meditation recordings and compliance with home practice will be monitored with a practice log. The prescribed home practice has been modified to accommodate the needs of the caregiver: each practice is offered in 5- to 10-minute intervals (5 min, 10 min, and 20 min practice) to accommodate the caregiver's schedule.
Group II: PsychoeducationActive Control1 Intervention
Psychoeducation (PSY) condition will be similar to MM with respect to number and duration of weekly sessions and daily homework. PSY is a lecture-based program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. Each session focuses on a specific topic related to wellness (e.g., nutrition, physical activity, medical screening) and caregiver-specific topics (e.g., understanding dementia and neurodegenerative disease, legal and financial issues).
Group III: Respite controlActive Control1 Intervention
Participant allocated to RC will not be exposed to a program, but will be offered 120-minutes of weekly respite care. Caregivers will be asked to record how they spend respite hours each week.

Find a Location

Who is running the clinical trial?

Toronto Metropolitan UniversityLead Sponsor
85 Previous Clinical Trials
10,750 Total Patients Enrolled
Alexandra Fiocco, PhDPrincipal InvestigatorToronto Metropolitan University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this medical research study?

"To be eligible for enrollment in this research study, potential participants must exhibit caregiver burden and fall within the age range of 50 to 100 years old. The trial aims to recruit approximately 232 patients."

Answered by AI

Is the process of enrolling participants still ongoing for this medical study?

"According to the current information available on clinicaltrials.gov, this trial is not actively seeking participants. The original posting of the study was on January 1st, 2024, with the most recent update made on December 28th, 2023. Although this specific trial is not enrolling patients at present, there are currently 76 other trials that are actively recruiting participants."

Answered by AI

Is the trial currently open to individuals who are below 18 years old?

"Individuals who are at least 50 years old but not more than a century old are sought after as potential participants for this trial."

Answered by AI
Recent research and studies
AssessmentJournal
Psychometric Properties of the Five Facet Mindfulness Questionnaire in Depressed Adults and Development of a Short Form
Bohlmeijer, Ernst, Peter M. ten Klooster, Martine Fledderus, Martine Veehof, and Ruth Baer. 2011. “Psychometric Properties of the Five Facet Mindfulness Questionnaire in Depressed Adults and Development of a Short Form”. Assessment. SAGE Publications. doi:10.1177/1073191111408231.
clinicaltrials.govStudy
Self-Care Training for Family Caregivers of Persons With Neurodegeneration
Alexandra J. Fiocco, PhD 2024. "Self-Care Training for Family Caregivers of Persons With Neurodegeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06200909.
~155 spots leftby Nov 2027
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