Protocol for Open Pilot of Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons with Dementia and Their Care-Partners Early After Diagnosis (Preprint)

Abstract

BACKGROUND Alzheimer’s disease and related dementias (ADRDs) are increasingly common progressive conditions that have a substantial impact on individuals and their primary care-partners—together described as a dyad. The stressors experienced by dyad members at around the time of ADRD diagnosis commonly produce clinically elevated emotional distress (i.e., depression and anxiety symptoms) which can become chronic and negatively impact health, relationships, and overall quality of life. Dyads commonly report unmet needs for early support to address these challenges early after diagnosis. OBJECTIVE This study is part of a larger study that has the primary objective to develop, adapt, and establish the feasibility of Resilient Together for Dementia (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress early after diagnosis. The present study protocol describes an open pilot of the RT-ADRD intervention. This study will allow the study team to gather feedback on intervention components, administration of study measures, issues within general protocol, and perceptions about live video interventions prior to a larger feasibility trial. METHODS All study procedures will be conducted virtually (via phone and healthcare-system supported videoconferencing) to optimize accessibility, inclusion, and representativeness. Eligible dyads will include couples (up to N=10) referred from Mount Sinai Hospital (MSH) clinics within 3 months of ADRD diagnosis. Dyads will be referred by their diagnosing clinicians (e.g., neurologists, geriatricians, neuropsychologists) and screened for eligibility. Eligible dyads will have at least one member who exhibits clinically elevated emotional distress and will demonstrate capacity to consent to research participation on a standardized assessment. Consenting dyads will complete baseline assessments of emotional distress, quality of life, relationship functioning, and resiliency skills. Dyads will then participate in six weekly RT-ADRD sessions together (30-60 minutes each). After the conclusion of the intervention, dyad members will complete post-test assessments with similar measures as the pre-test. Finally, dyads will participate together in a single 60-minute exit interview to gather information on intervention content and procedures to refine the intervention before a pilot feasibility trial. RESULTS This study has been approved by the MSH Institutional Review Board and is registered on ClinicalTrials.gov (NCT06421545). We anticipate that the study will be completed by late 2024. CONCLUSIONS We will use results from the present study to administer changes and develop procedures for a pilot feasibility trial of RT-ADRD relative to a minimally enhanced control condition. Our study will allow us to gather comprehensive information on proposed RT-ADRD procedures and content and the best ways of delivering prevention-focused interventions to reduce the potential for chronic emotional distress stemming from ADRDs. CLINICALTRIAL NCT06421545