Stressor-Oriented MUlticomponent Intervention and the WeLl-Being of Patients with Alzheimer's Disease: A Randomized Controlled Trial (SOUL-P).

BACKGROUND Patients with Alzheimer's disease (AD) experience various stressors that negatively impact well-being. Most studies have, however, small effect size and are limited by the experiences of severe patients. Therefore, we conducted a single-blind, randomized controlled trial, which has included patients at different stages. OBJECTIVE The stressor-oriented multicomponent program was designed as an intervention for AD patients to enhance well-being. METHODS Patients were randomly assigned to control or SOUL-P conditions according to disease severity. The SOUL-P group received 15 intensive sessions over 6 months and 6 maintenance sessions over a 6-month follow-up by a multidisciplinary team comprising psychologists, occupational therapists, and community nurses. The control group received a similar number of sessions by community nurses. Stress-related outcomes (primary stressors and well-being outcomes) were obtained from in-person baseline and follow-up interviews conducted at 6- and 12-months post-baseline. A treatment compliance survey was conducted at the intervention endpoint for patients. RESULTS Of the 863 patients screened, 218 (25.3%) were eligible. At 6 months, compared to controls, SOUL-P patients had improved quality of life (QoL) (p <  0.001; Cohen d = 0.56), depression (p = 0.020; Cohen d = -0.33), neurobehavioral symptoms (p = 0.034; Cohen d = -0.30), perceived stress (p = 0.030; Cohen d = -0.31), and family conflict (p = 0.026; Cohen d = -0.32). QoL, depression, perceived stress, and family conflict were still significantly different at 12 months. Most patients were satisfied with SOUL-P, while caregivers in the SOUL-P group reported overloading tasks. CONCLUSION SOUL-P may reduce perceived stress and improve psychological outcomes in AD patients. Stressor-based interventions, patient-oriented goals, and a multidisciplinary team are essential features for a successful SOUL-P.