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Cognitive Behavioural Therapy of Early Dementia (KORDIAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735046
First Posted: August 14, 2008
Last Update Posted: January 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Leipzig
Zentralinstitut für Seelische Gesundheit Mannheim
Humboldt-Universität zu Berlin
Information provided by:
Technische Universität München
  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:


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 ]

Secondary Outcome Measures:
  • Quality of life, depression, neuro-psychiatric symptoms [ Time Frame: Same as for primary outcome ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Mannheim
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
First Submitted: August 13, 2008
First Posted: August 14, 2008
Last Update Posted: January 14, 2011
Last Verified: July 2008

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
Neurocognitive Disorders
Mental Disorders