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Clinical Trials/NCT01055509
NCT01055509
Completed
Not Applicable

Effectiveness of Cognitive Adaptation Training Applied to Cognitive Impairment in Schizophrenia - A Randomised Trial

University of Southern Denmark2 sites in 1 country65 target enrollmentJanuary 2009
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Southern Denmark
Enrollment
65
Locations
2
Primary Endpoint
Changes in Social functioning assessed by Global Assessment of Function test and Health of the Nation Outcome Scales item 9-12 concerning social problems.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to determine whether Cognitive Adaptation Training are effective in comparison with conventional treatment, focusing on social functions, symptoms, relapse, re-hospitalisation, and quality of life in outpatients with schizophrenia.

Detailed Description

It is estimated that approximately 80% of patients with schizophrenia have reduced cognitive functions, representing problems with attention, verbal memory, short-term memory and executive functions (1-3). These impairments might have an impact on the patients ability to complete rehabilitation programmes, apply learned strategies to social problems, develop work skills and manage daily life (4,5). The effect of Cognitive Adaptation Training has been tested as a psychosocial treatment including training of compensatory strategies in order to sequence patient's adaptive behaviour, showing promising results concerning improved social functions (6). There are however no solid evidence for these statements. The existing few studies investigating the effect of Cognitive Adaptation Training (6-8) are underpowered (small sample sizes) and have a lack of younger patients, which limits the conclusions that can be drawn from the results of the improvement. The present trial employs a prospective design of 26 weeks with a follow-up period of 9 months after inclusion. The study will enroll 164 consecutively recruited participants from three Danish out-patient teams for young adults with a first episode of psychosis.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
August 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Birte Oestergaard

Associate professor

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of schizophrenia.
  • More than one year from referral to the psychiatric clinic.
  • Receive mental medication and continual psychosocial treatment.
  • Participants who have signed informed consent.

Exclusion Criteria

  • Participants who don't understand or speak Danish.
  • Participants who live at an institution or who are long-term hospitalized.
  • Participants who are unwillingly to complete protocol.

Outcomes

Primary Outcomes

Changes in Social functioning assessed by Global Assessment of Function test and Health of the Nation Outcome Scales item 9-12 concerning social problems.

Time Frame: Baseline, six month and nine month.

The effect of intervention on primary outcome are invetigated as longitudinal data at six and nine month. The data are analysed using mixed models.

Secondary Outcomes

  • Changes in Social Functioning using Camberwell Assessment of Need questionnaire. Symptoms using Positive and Negative Syndrome Scale. Quality of Life using Lehman Quality of Life Interview-brief version. Relapse and frequency of hospitalization.(Baseline, six month and nine month.)

Study Sites (2)

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