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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Psychiatric University Hospital, Zurich
Information provided by (Responsible Party):
Simon Forstmeier, University of Zurich
ClinicalTrials.gov Identifier:
NCT01273272
First received: January 3, 2011
Last updated: May 11, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease
Behavioral: Comprehensive, CBT-based, multi-component treatment
Behavioral: Treatment as usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment
Behavioral: Comprehensive, CBT-based, multi-component treatment
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 Name: Psychosocial intervention
Active Comparator: Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
Behavioral: Treatment as usual
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 Name: Standard treatment

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).

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273272

Locations
Switzerland
Psychiatric University Hospital, Clinic for Geriatric Medicine
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Psychiatric University Hospital, Zurich
Investigators
Principal Investigator: Simon Forstmeier, Ph.D. University of Zurich
Study Chair: Andreas Maercker, M.D.,Ph.D. University of Zurich
Study Chair: Egemen Savaskan, M.D. Psychiatric University Hospital, Zurich
Study Chair: Tanja Roth, Ph.D. Psychiatric University Hospital, Zurich
  More Information

Publications:
Forstmeier S, Maercker A. Problems of aging. Psychotherapy in older age [German]. Göttingen, Germany: Hogrefe. 2008.
Forstmeier S, Maercker A. Psychotherapie im Alter. Psychotherapeutenjournal 4: 340-352, 2007

Responsible Party: Simon Forstmeier, Ph.D., University of Zurich
ClinicalTrials.gov Identifier: NCT01273272     History of Changes
Other Study ID Numbers: 10-130034/1a 
Study First Received: January 3, 2011
Last Updated: May 11, 2016
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Cognitive Behavior Therapy
Early dementia, Alzheimer type

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016