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

November 1, 2017 updated by: Simon Forstmeier, University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Psychiatric University Hospital, Clinic for Geriatric Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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)
Time Frame: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
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
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
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-130034/1a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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