Cognitive Behavioural Therapy of Early Dementia

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

Sponsors

Lead Sponsor: Technische Universität München

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

Source Technische Universität München
Brief Summary

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

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.

Overall Status Completed
Start Date April 2008
Completion Date April 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Functional ability in the everyday context Baseline, post treatment, 6 months post treatment
Secondary Outcome
Measure Time Frame
Quality of life, depression, neuro-psychiatric symptoms Same as for primary outcome
Enrollment 200
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive behavioral therapy for early Alzheimer's disease

Description: 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.

Arm Group Label: 1

Intervention Type: Other

Intervention Name: Control

Description: Patients and proxies who are assigned to treatment as usual

Arm Group Label: 2

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alexander Kurz, MD Study Director Klinikum rechts der Isar
Location
Facility: Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen
Location Countries

Germany

Verification Date

July 2008

Responsible Party

Name Title: Alexander Kurz M.D.

Organization: klinikum rechts der Isar

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 1

Description: Intervention

Label: 2

Description: control

Acronym KORDIAL
Study Design Info

Time Perspective: Prospective

Source: ClinicalTrials.gov