Recruiting

Group-Based Interventions

Sponsor:

Massachusetts General Hospital

Code:

NCT07868588

Conditions

Elevated Caregiver Strain

Dementia Caregiver

Caregiver Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caring Together

Savvy Caregiver

Study Details

Brief summary:

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.

Conditions

Elevated Caregiver Strain

Dementia Caregiver

Caregiver Stress

Study ID

NCT07868588

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Feb 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

While the below criteria reference both the caregiver and care recipient, only caregivers will be enrolled in this study.

Inclusion Criteria:

  • Caregiver of a person with memory loss currently
  • Care recipient currently living in community
  • Caregiver at least 18 years of age
  • Caregiver Zarit Burden Interview-6 (ZBI-6) greater than or equal to 9 or ZBI-22 greater than or equal to 34
  • English or Spanish fluency/literacy
  • Able and willing to participate

Exclusion Criteria:

  • Care recipient enrolled or planning to enroll in hospice
  • Severe, untreated mental illness or substance use (self or clinician report)
  • Active suicide risk
  • Residence outside the U.S. during study procedures

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Caring Together

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

LIGHTEN Study Coordinator

617-724-1279mghlightenstudy@mgb.org

Locations

Mass General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

LIGHTEN Study Coordinator

617-724-1279mghlightenstudy@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Caregiving
  • Cognitive Behavioral Therapy
  • Zarit Burden Interview
  • Dementia caregiving
  • Caring Together
  • Savvy Caregiver
  • Caregiver Stress
  • Alzheimer's Caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.