RANDOMIZED TRIAL OF TREATMENT FOR POST-STROKE DEPRESSION

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

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Abstract

Description (adapted from investigator's abstract): Post-stroke depression (PSD) is a prevalent condition that has pervasive effects on patients' functional recovery and health-related quality of life (HRQOL), as well as outcomes of caregivers. The long-term objective of this proposal is to evaluation the effectiveness of a multi-faceted, 12 week intervention (AIM) that seeks to activate patients to be aware of PSD, initiate antidepressant treatment, and monitor treatment side effects and compliance. The specific aims are to improve: 1) depression symptoms, and 2) stroke-specific quality of life outcomes in patients with PSD. We will enroll 244 ischemic stroke patients who exhibit PSD 1 month post-stroke and randomize them to the AIM intervention vs. usual care. Patients received standardized assessments based on a conceptual framework of stress and coping. Variables include social support, stroke severity, depression, HRQOL, life satisfaction and functional outcomes. Primary depression outcomes are determined 3 months following randomization. We will also examine the durability of the intervention by comparing outcomes at 9 months following randomization. The study protocol requires assembly of a prospective cohort of ischemic stroke patients with and without PSD. Thus, a secondary objective of this study is to capitalize on this opportunity by assessing outcomes in non-depressed stroke survivors (n=244) and stroke caregivers (n=340). These secondary aims are to evaluate the effects of PSD by comparing: 1) outcomes in depressed and non-depressed patients, and 2) in caregivers of depressed and non-depressed patients. Secondary analyses will use the rich post-stroke database to evaluate longitudinal depression and HRQOL outcomes in patients and caregivers, examine the relationship of patient and caregiver outcomes post-stroke, and compare the health care utilization of patients with and without PSD.