Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Comprehensive, CBT-based, multi-component treatment
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included. Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, & McHugh, 1975). The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help. A caregiver must be available to take part in most of the therapy sessions. Exclusion Criteria: concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT)<br>Comprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment | Behavioral: Comprehensive, CBT-based, multi-component treatment<br>* 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).<br>* Other names: Psychosocial intervention;|
| Active Comparator: Treatment as usual (TAU)<br>Standard Treatment (medical and psychosocial) | Behavioral: Treatment as usual<br>* 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.<br>* Other names: Standard treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Geriatric Depression Scale (GDS) |  | Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Neuropsychiatric Inventory (NPI) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up | 
| Caregiver: Change from baseline in Short-Form Health Survey (SF-12) |  | 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) |  | 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) |  | Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy, Early dementia, Alzheimer type