Psychiatric University Hospital, Clinic for Geriatric Medicine
Zurich, 8032, Switzerland
NCT Number: NCT01273272
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.
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Notify Me50 year–95 year
All sexes
Interventional
Phase 2
Zurich, 8032, Switzerland
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Psychosocial intervention
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.
Other names: Standard treatment
Time frame: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Time frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
University of Zurich
Other
Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
Acronym: CBTAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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