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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling. It consists of 20 weekly sessions (plus appr. 5 single session with caregiver).
Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
Psychiatric University Hospital, Clinic for Geriatric Medicine
Zurich, Switzerland
Change from baseline in Geriatric Depression Scale (GDS)
Time frame: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Neuropsychiatric Inventory (NPI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Bayer-Activities of Daily Living (B-ADL)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Stress Coping Inventory (SCI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Apathy Evaluation Scale (AES)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Stress Coping Inventory (SCI)
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up