This application is submitted for consideration as a R21 MH Exploratory/Development Grant. Using a randomized two group design, we propose a pilot study to evaluate the feasibility and derive effect sizes for an innovative intervention that targets community-living persons with dementia (care recipients - CR) and their family caregivers (CG). The intervention, Activity Engagement Program involves identifying the cognitive functional capabilities of CR, developing customized meaningful activities that match functioning, previous roles, habits and interests, and training CGs in specific techniques (problem-solving, communication, task and environmental simplification) to effectively engage CRs. Allen's Cognitive Disabilities Model and standardized assessments are used to identify CR areas of strength and preserved capabilities. The 8 session, 4-month in-home intervention is designed to reduce depressive affect and agitated behaviors of persons with dementia, and to reduce burden and depressive symptoms and enhance mastery of family caregivers. Although activities are routinely used as a therapeutic modality to reduce agitation and depressive affect in residential facilities, no systematic studies have been conducted to test this approach with at home CR-CG dyads. Agitated behaviors and depressive affect is associated with increased health care costs of dementia patients and significant caregiver burden. Thus, the intervention seeks to impact outcomes that are clinically significant and a public health concern. Prior to implementing a full scale randomized controlled trial, a planning grant is necessary to refine intervention protocols, derive estimates of the magnitude of study effects, assure CR and CG acceptability of and compliance to intervention techniques, and explore the mechanisms of action or pathways by which treatment effects may occur. In this pilot, 60 CR-CG dyads will be randomly assigned to intervention or to a wait list control group that will receive the same intervention following the 4-month post-test. The wait list group will receive another follow-up battery 4 months following intervention (8 months from baseline). All study aims will be evaluated on 60 dyads.
The specific aims are to: (1) estimate a preliminary effect size of the impact of intervention on CR depressive affect and agitated behaviors at 4-months; (2) evaluate CR acceptance of and engagement in activities; (3) estimate a preliminary effect size of the impact of intervention on CG burden, depressive symptoms and mastery at 4-months, and (4) evaluate CG acceptance of and compliance with intervention techniques. We also propose to explore the mechanisms or pathway by which treatment gains are obtained. We will evaluate if treatment effects differ for CGs with high or low levels of depressive symptoms, the possible moderator effect of CG depression on CR outcomes, and if CR improvements mediate CG outcomes. This pilot study will provide critical data by which to refine and standardize the intervention manual and protocols, and structure the design of a large-scale randomized clinical trial.
