Cognitive Behavioural Therapy of Early Dementia

Completed

• Conditions: Dementia
• Interventions: Other: Control; Behavioral: Cognitive behavioral therapy for early Alzheimer's disease

• Registration Number: NCT00735046
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-07
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Completion: 2010-04
• Last Update Submitted: 2011-01-13
• Last Update Posted: 2011-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Control	control
1	Cognitive behavioral therapy for early Alzheimer's disease	Intervention

Primary Outcome Measures

Name	Time	Method
Functional ability in the everyday context	Baseline, post treatment, 6 months post treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life, depression, neuro-psychiatric symptoms	Same as for primary outcome

Trial Locations

Locations (1)

Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen; 🇩🇪 Munich, Bavaria, Germany