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Cognitive Behavioural Therapy of Early Dementia (KORDIAL)

This study has been completed.
Sponsor:
Collaborators:
University of Leipzig
Zentralinstitut für seelische Gesundheit, Abteilung Gerontopsychiatrie J5,
Humboldt-Universität zu Berlin
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00735046
First received: August 13, 2008
Last updated: January 13, 2011
Last verified: July 2008
History of Changes
  Purpose

A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.


Condition Intervention
Dementia
 Behavioral: Cognitive behavioral therapy for early Alzheimer's disease
Other: Control

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Functional ability in the everyday context [ Time Frame: Baseline, post treatment, 6 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, depression, neuro-psychiatric symptoms [ Time Frame: Same as for primary outcome ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

not required


Estimated Enrollment: 200
Study Start Date: April 2008
Study Completion Date: April 2010
Groups/Cohorts Assigned Interventions
1
Intervention
 Behavioral: Cognitive behavioral therapy for early Alzheimer's disease
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
 Other: Control
Patients and proxies who are assigned to treatment as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735046

Locations
Germany
Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
University of Leipzig
Zentralinstitut für seelische Gesundheit, Abteilung Gerontopsychiatrie J5,
Humboldt-Universität zu Berlin
Investigators
Study Director: Alexander Kurz, MD Klinikum rechts der Isar
  More Information

Publications:

Responsible Party: Alexander Kurz M.D., klinikum rechts der Isar
ClinicalTrials.gov Identifier: NCT00735046     History of Changes
Other Study ID Numbers: KOR-683-KUR-0000-I
Study First Received: August 13, 2008
Last Updated: January 13, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Early dementia in Alzheimer's disease (MMSE ≥ 21)

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013