Cognitive Behavioural Therapy of Early Dementia

Dementia Clinical Trial

— KORDIAL  

Official title:

Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735046
• Other study ID #: KOR-683-KUR-0000-I
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: January 13, 2011
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2008
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dementia

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.

Other:
• Control
Patients and proxies who are assigned to treatment as usual

Locations

Country	Name	City	State
Germany	Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen	Munich	Bavaria

Sponsors (4)

Lead Sponsor	Collaborator
Technische Universität München	Humboldt-Universität zu Berlin, University of Leipzig, Zentralinstitut für Seelische Gesundheit Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kliegel M, Eschen A, Thöne-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. — View Citation

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. — View Citation

Werheid K, Thöne-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional ability in the everyday context		Baseline, post treatment, 6 months post treatment	No
Secondary	Quality of life, depression, neuro-psychiatric symptoms		Same as for primary outcome	No