Alzheimer Disease Clinical Trial
Official title:
Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.
Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of
all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms
are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience
neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These
symptoms are associated with greater morbidity, reduced quality of life for the patient,
increased burden and depression for the caregiver, higher costs of care, and nursing home
placement. Thus, interventions aimed at treating these symptoms could have a tremendous
effect on pa-tients, caregivers, and society.
This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based,
multi-component treatment programme consisting of eight modules (diagnosis and goal-setting;
psycho-education; engagement in pleasant activities; cognitive restructuring; life review;
training caregiver in behavior management techniques; interventions for the caregiver;
couples counseling) and 20 sessions.
This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in
the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers.
Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and
suffer under any neuropsychiatric symptom will be included. The patients and their caregiver
will be randomized to either the CBT-based intervention or to the control condition that
receives treatment as usual (TAU).
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