Elevated Caregiver StrainLIGHTENNCT07868588
Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
A study testing Caring Together and Savvy Caregiver in people with Elevated Caregiver Strain and Dementia Caregiver, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Caregiver Strain, Dementia Caregiver, Caregiver Stress
- What is being tested?
- Caring Together and Savvy Caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2026to 1 Jul 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
LIGHTEN Study Coordinator, 617-724-1279, mghlightenstudy@mgb.org
About this study
Official title: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
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.
Read the detailed description
The aim of this clinical trial is to conduct a randomized, comparative effectiveness trial (N=450) of two group-based, telehealth programs for caregivers of persons with memory loss. The central goal is to test which of the evidence-based behavioral intervention comparators - Caring Together or Savvy Caregiver - should be implemented in real-world clinical practice to reduce elevated caregiver strain. Investigators will evaluate:
Aim 1: Whether group-delivered telehealth Caring Together is superior to group-delivered telehealth Savvy Caregiver in reducing elevated caregiver strain (primary outcome; as measured by the Zarit Burden Interview [ZBI]) as well as secondary outcomes of caregiver depression, caregiver anxiety, caregiver physical health, and behavioral and psychiatric symptoms of memory loss, at post-treatment.
Aim 2: Whether improvements in both Caring Together and Savvy Caregiver will be maintained over a 6-month follow-up.
Aim 3: Heterogeneity of treatment effects (HTE) analyses to examine treatment preference as the primary potential source of HTE. The investigators will explore additional potential sources of HTE, including relationship type (i.e., spouse versus other), service utilization (e.g., respite, case management), caregiver gender (i.e., woman versus other), and caregiver network size.
The investigators will recruit caregivers of persons with memory loss who are reporting caregiver strain from partner dementia care clinics at Mass General Brigham, the University of Rochester, the University of Colorado, and Tufts Medical Center. Participants will also be recruited through social media and community-based organizations.
Enrolled participants will be randomized to one of two programs (Savvy Caregiver or Caring Together) and will complete 6 weekly 120-minute sessions via Zoom delivered by a clinical psychologist or trainee. Participants will complete self-reported assessments at 3 timepoints: before the intervention, after the intervention, and 6-months after completing the intervention.
Participants will participate in weekly 120-minute virtual group sessions in small groups (6-8 participants) over the course of 6 weeks delivered by trained behavioral clinicians. The investigators will run groups in English and Spanish.
After completing the intervention, participants will be administered post-intervention assessments, and a follow-up survey at 6 months.
- Being tested
- Caring Together, Savvy Caregiver
- Keywords
- Caregiving, Cognitive Behavioral Therapy, Zarit Burden Interview, Dementia caregiving, Caring Together, Savvy Caregiver, Caregiver Stress, Alzheimer's Caregiver
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring TogetherBehavioural
Also called CT
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 CaregiverBehavioural
Also called SC
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Savvy Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview (ZBI-22)
22-item self-report of caregiver strain. Higher scores (min = 0, max = 88) indicate higher burden related to caregiving.
Measured: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
9-item self-report assessing symptoms of depression. Higher total scores (min=0, max=27) indicate greater severity of depressive symptoms.
Measured: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
General Anxiety Disorder-7 (GAD-7)
7-item self-report measure of general anxiety symptoms. Higher total scores (min=0, max=21) indicate greater anxiety severity.
Measured: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
PROMIS Global Physical Health 4a (PROMIS-GPH)
4-item self-report of overall physical health, physical function, pain, and fatigue. Higher T scores (mean=50, SD =10) indicate greater perceived general physical wellbeing.
Measured: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Neuropsychiatric Inventory Questionnaire (NPI-Q)
12-item self-report assessing behavioral and psychological symptoms in persons with memory loss. Study team will assess symptom severity (min=0, max=36, higher scores indicate greater neuropsychiatric symptom burden) and distress (min=0, max=60, higher scores indicate greater caregiver distress due to symptomology).
Measured: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start13 Oct 2026
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Caregiver StrainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Colorado, Denver, Tufts Medical Center, University of Rochester
- Responsible party
- Principal investigator, Evan Plys, Massachusetts General Hospital
- Investigators
- Evan Plys, PhD, Principal investigator, Massachusetts General HospitalAna-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868588
- Sponsor's protocol ID
- 2026P001819
- Other IDs
- MBH-2025C1-43605
- Acronym
- LIGHTEN
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No