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.
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
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
Parallel
Caring Together
BehavioralCaring 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
BehavioralSavvy 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.
Zarit Burden Interview (ZBI-22)
22-item self-report of caregiver strain. Higher scores (min = 0, max = 88) indicate higher burden related to caregiving.
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.
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.
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.
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).
Caregiver Self-Efficacy Scale-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.
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.
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.
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.
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Massachusetts General Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Colorado, Denver
Collaborator
Tufts Medical Center
Collaborator
University of Rochester
Collaborator
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