Background: Alzheimer 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 (ie, depression and anxiety symptoms), which can become chronic and negatively impact health, relationships, and the 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 on the web (via phone and health care 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 an ADRD diagnosis. Dyads will be referred by their diagnosing clinicians (eg, neurologists, geriatricians, and 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 6 weekly RT-ADRD sessions together (30-60 minutes each). After the conclusion of the intervention, dyad members will complete posttest assessments with similar measures as the pretest. 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 these results 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.
International Registered Report Identifier (irrid): DERR1-10.2196/60382.
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http://dx.doi.org/10.2196/60382 | DOI Listing |
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