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Behavioural Intervention

Mindfulness Program for Caregiver Stress (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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (6-8 weeks post baseline), 3-months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Home Practice

Adherence to treatment

Credibility and Expectancy

+10 more

Other study objectives

Caregiver self-efficacy

Compassion

Distress Due to Patient Challenges Behaviors

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met