NCT07868588

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
58mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

October 9, 2026

Status Verified

September 1, 2026

Enrollment Period

4.3 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Elevated Caregiver StrainDementia CaregiverCaregiver Stress

Keywords

CaregivingCognitive Behavioral TherapyZarit Burden InterviewDementia caregivingCaring TogetherSavvy CaregiverCaregiver StressAlzheimer's Caregiver

Outcome Measures

Primary Outcomes (1)

  • Zarit Burden Interview (ZBI-22)

    22-item self-report of caregiver strain. Higher scores (min = 0, max = 88) indicate higher burden related to caregiving.

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

Secondary Outcomes (4)

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • General Anxiety Disorder-7 (GAD-7)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • PROMIS Global Physical Health 4a (PROMIS-GPH)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • Neuropsychiatric Inventory Questionnaire (NPI-Q)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

Other Outcomes (4)

  • Caregiver Self-Efficacy Scale-8

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • Leisure Time Satisfaction (LTS)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • Dysfunctional Thoughts about Caregiving Questionnaire (DTCQ)

    Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention

  • +1 more other outcomes

Study Arms (2)

Caring Together

ACTIVE COMPARATOR

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.

Behavioral: Caring Together

Savvy Caregiver

ACTIVE COMPARATOR

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.

Behavioral: Savvy Caregiver

Interventions

Caring TogetherBEHAVIORAL

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.

Also known as: CT
Caring Together
Savvy CaregiverBEHAVIORAL

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.

Also known as: SC
Savvy Caregiver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • English or Spanish fluency/literacy
  • Able and willing to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Evan Plys, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Ana-Maria Vranceanu, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LIGHTEN Study Coordinator

CONTACT

617-724-1279mghlightenstudy@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

October 5, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

October 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)