Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07868588
Status
Not Yet Recruiting

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Conditions

  • Caregiver Stress
  • Dementia Caregiver
  • Elevated Caregiver Strain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Caring Together — BEHAVIORAL
    Caring Together is the standard treatment for elevated caregiver strain. Caring Together follows the Stress-Process Model and teaches basic illness knowledge, and problem-solving frameworks to increase self-efficacy and psychological coping skills of cognitive reframing and behavioral activation for self care.
  • Savvy Caregiver — BEHAVIORAL
    Savvy Caregiver is a widely structured multi-component behavioral interventions for elevated caregiver strain. Savvy Caregiver is also rooted in the Stress-Process Model, rooted in providing illness education, problem-solving frameworks, and psychological coping skills.

Study Details

The goal of this clinical trial is to compare two group-based interventions for caregivers of persons with memory loss (N=450) delivered via telehealth. The aim is to evaluate which program is most effective for different types of caregivers in reducing stress, improving coping, and increasing confidence related to caregiving. Participants will be randomly assigned to one of the two programs, as well as be asked to complete study assessments at baseline (week 0), post-intervention (week 7), and 6-month follow-up.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 5, 2026
Status verified
Sep 2026
Primary completion
Feb 1, 2031
Completion
Jul 1, 2031

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Caring Together
    Caring Together is a cognitive-behavioral therapy utilized for patients experiencing elevated caregiver strain. This program is designed to help caregivers of persons living with memory problems diagnosis build coping skills, reduce stress, find more moments of joy, and feel less alone in their role. The small group-based structure focuses on practical tools for managing difficult emotions, responding to dementia-related challenges, and strengthening resilience and self-care. The program focuses on coping with stress and learning how to modify negative thoughts, feelings, and behaviors that caregivers often experience.
  • Active Comparator: Savvy Caregiver
    Savvy Caregiver is a structured, multi-component behavioral intervention for elevated caregiver strain. This program is designed to help caregivers of persons living with memory problems feel more confident, less overwhelmed, and better prepared to respond to day-to-day challenges. The small group-based program structure focuses on understanding dementia symptoms, structuring daily routines, and responding to challenges that arise, while also considering your own well-being. This program focuses on understanding dementia and practical problem-solving strategies for common challenges caregivers experience.

Primary Outcome Measure

Zarit Burden Interview (ZBI-22) [ Time Frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General HospitalBostonMassachusetts02114-

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By research site
Mass General Hospital· Boston, MA

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