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Behavioural Intervention
Mindful and Self-Compassionate Care Program (MASC) for Caregiver (SOCIAL Trial)
N/A
Recruiting
Led By Ana-Maria Vranceanu, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (6-8 weeks post baseline), 3-months post intervention
Awards & highlights
SOCIAL Trial Summary
This trial aims to test a program called Mindful and Self-Compassionate Care Program (MASC) to help caregivers of individuals with Alzheimer's Disease and Related Dementias manage stress. The
Who is the study for?
This trial is for caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD) who experience stress from their caregiving duties. It aims to help them manage this stress, including the challenges that come with difficult patient behaviors.Check my eligibility
What is being tested?
The trial tests a new program called MASC which teaches mindfulness, self-compassion, and behavioral management skills through group training. Its effectiveness will be compared to a Health Education Program in a pilot randomized controlled trial.See study design
What are the potential side effects?
Since MASC involves educational and skill-building activities without medical or pharmaceutical interventions, significant side effects are not anticipated. However, discussing emotional topics could potentially cause temporary discomfort.
SOCIAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
SOCIAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (6-8 weeks post baseline), 3-months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (6-8 weeks post baseline), 3-months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Home Practice
Adherence to treatment
Credibility and Expectancy
+10 moreOther outcome measures
Caregiver self-efficacy
Compassion
Distress Due to Patient Challenges Behaviors
+9 moreSOCIAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful and Self-Compassionate Care Program (MASC)Experimental Treatment1 Intervention
The intervention arm will be comprised of:
Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Group II: Health Education Program (HEP)Active Control1 Intervention
The control arm will be comprised of:
Six Virtual Group Sessions. The sessions will discuss caregiver stress, sleep hygiene, nutrition, and ways to stay physically active as a caregiver.
At Home Practice. After each group session, participants will have the opportunity to complete journal exercises that encourage them to integrate the health information that they learn into their daily lives.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,561 Total Patients Enrolled
University of California, San FranciscoOTHER
2,507 Previous Clinical Trials
15,238,495 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,805 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are prospective participants able to enroll in this research study at the present time?
"Information available on clinicaltrials.gov shows that this particular medical study, initially posted on March 5th, 2024 and last revised on February 18th, 2024, is not actively seeking participants. However, there are currently 1021 alternative clinical trials actively recruiting patients at this time."
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