Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01055509
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2011-04
• Study Completion: 2011-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Name	Time	Method
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.	The effect of intervention on secondary outcome are invetigated as longitudinal data at six and nine month. The data are analysed using mixed models. However, relapse are analysed using survival analysis.

Trial Locations

Locations (2)

Early Intervention Team; 🇩🇰 Odense, Denmark

Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe; 🇩🇰 Esbjerg N, Denmark