Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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).
    

Intervention name(s): Comprehensive, CBT-based, multi-component treatment; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Psychosocial intervention; Standard treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Early dementia, Alzheimer type