Cognitive Behavioural Therapy of Early Dementia (KORDIAL)
January 13, 2011 updated by: Technical University of Munich
Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting
A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease.
The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies.
Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined.
The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months.
The control condition will be treatment as usual.
The study will be conducted in 5 university outpatient units and in 5 specialist offices.
Study Type
Observational
Enrollment (Anticipated)
200
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
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Bavaria
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Munich, Bavaria, Germany, 81675
- Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen
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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
18 years to 95 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices
Description
Inclusion Criteria:
- Mild dementia (MMSE > 21) in Alzheimer's disease (ICD-10), proxy available
Exclusion Criteria:
- Acute of unstable psychiatric or physical disease, proxy unavailable
- Participation in another trial
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Intervention
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12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session.
Intervention is manualized but is flexible with regard to individual resources and needs.
|
|
2
control
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Patients and proxies who are assigned to treatment as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional ability in the everyday context
Time Frame: Baseline, post treatment, 6 months post treatment
|
Baseline, post treatment, 6 months post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life, depression, neuro-psychiatric symptoms
Time Frame: Same as for primary outcome
|
Same as for primary outcome
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Alexander Kurz, MD, Klinikum rechts der Isar
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
- Kliegel M, Eschen A, Thone-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. doi: 10.1016/j.bandc.2004.05.005.
- Werheid K, Thone-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. doi: 10.1007/s00115-005-1998-2. German.
- Kurz A, Pohl C, Ramsenthaler M, Sorg C. Cognitive rehabilitation in patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2009 Feb;24(2):163-8. doi: 10.1002/gps.2086.
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
April 1, 2008
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 13, 2008
First Posted (ESTIMATE)
August 14, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 14, 2011
Last Update Submitted That Met QC Criteria
January 13, 2011
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOR-683-KUR-0000-I
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.