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Completed

NCT Number: NCT00735046

Cognitive Behavioural Therapy of Early Dementia

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

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy for early Alzheimer's disease

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.

Control

Other

Patients and proxies who are assigned to treatment as usual

Primary outcomes

  1. Functional ability in the everyday context

    Time frame: Baseline, post treatment, 6 months post treatment

Secondary outcomes

  1. Quality of life, depression, neuro-psychiatric symptoms

    Time frame: Same as for primary outcome

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Humboldt-Universität zu Berlin
  • University of Leipzig
  • Zentralinstitut für Seelische Gesundheit Mannheim

Registry information

Official study title

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

Acronym: KORDIAL

Important dates

Study start
2008
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Jan 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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