Overview
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.
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.
Eligibility
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
