Cognitive Behavioural Therapy of Early Dementia

NCT ID: NCT00735046

Last Updated: 2011-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Intervention

Cognitive behavioral therapy for early Alzheimer's disease

Intervention Type BEHAVIORAL

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

Control

Intervention Type OTHER

Patients and proxies who are assigned to treatment as usual

Interventions

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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.

Intervention Type BEHAVIORAL

Control

Patients and proxies who are assigned to treatment as usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role collaborator

Zentralinstitut für Seelische Gesundheit Mannheim

OTHER

Sponsor Role collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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klinikum rechts der Isar

Principal Investigators

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Alexander Kurz, MD

Role: STUDY_DIRECTOR

Klinikum rechts der Isar

Locations

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Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15380875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16228161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18636436 (View on PubMed)

Other Identifiers

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KOR-683-KUR-0000-I

Identifier Type: -

Identifier Source: org_study_id

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