An interventional study of Caring Together and Savvy Caregiver in Elevated Caregiver Strain, Dementia Caregiver and Caregiver Stress, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's planned enrollment of 450 is above the median of 75 across 346 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
While the below criteria reference both the caregiver and care recipient, only caregivers will be enrolled in this study.
Inclusion Criteria:
Exclusion Criteria:
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 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
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
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
Zarit Burden Interview (ZBI-22)
22-item self-report of caregiver strain. Higher scores (min = 0, max = 88) indicate higher burden related to caregiving.
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Caregiver Self-Efficacy Scale-8 (CSES-8)
8-item self-report assessing caregiver confidence and self-efficacy. Higher total scores (min=8, max=80) indicate greater confidence in maintaining personal activities along with the caregiver role.
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Leisure Time Satisfaction (LTS)
7-item self-report assessing satisfaction with the amount of time participants have for leisure activities. Higher total scores (min=0, max=14) indicate greater fulfilment and satisfaction with one's ability to engage in their everyday enjoyable activities while caregiving.
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Dysfunctional Thoughts about Caregiving Questionnaire (DTCQ)
16-item self-report assessing negative or rigid thoughts and beliefs common among caregivers. Higher scores (min=0, max=64) indicate a more maladaptive approach to caregiving.
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Brief-COPE Dysfunctional Coping Subscale
12-item self-report assessing effective and ineffective ways of coping with stress, using dysfunctional coping strategies. Higher scores (min = 12, max = 48) indicate greater utilization of different dysfunctional coping methods.
Time frame: Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2031, 51 months after the start.
Of 253 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 51 months is above that.
Counting every sponsor, half of 261 studies reached it within 16 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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