Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia (CAT-Denmark)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birte Oestergaard, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01055509
First received: January 22, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Behavioral: Cognitive Adaptation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Cognitive Adaptation Training Applied to Cognitive Impairment in Schizophrenia - A Randomised Trial

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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. [ Time Frame: Baseline, six month and nine month. ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Adaptation Training
Cognitive adaptation training and treatment as usual
Behavioral: Cognitive Adaptation Training
All patients receive treatment as usual. Additionally, patients in the intervention arm receives training concerning solving concrete problems related to the patient's daily life using tools such as schedules, schemes and signs. Additional the patient can receive SMS messages or instructions for the use of schedules in cell-phones to prompt for activities. The intervention is conducted in the patients homes every 14th day in a period of six months.
Other Names:
  • Memory disorders
  • Adaptation
No Intervention: Treatment as ususal
Pharmacological treatment, weekly contact to professionals (often in patient's homes), psychoeducation, social skill training in groups and psychosocial intervention with relatives.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055509

Locations
Denmark
Early Intervention Team
Aabenraa, Denmark, DK.6200
Schizophrenic Clinic, Psychiatric Department in Esbjerg and Ribe
Esbjerg N, Denmark, DK-6715
Early Intervention Team
Odense, Denmark, Dk-5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
Principal Investigator: Lise Hounsgaard, PhD Research Unit of Nursing
  More Information

Publications:

Responsible Party: Birte Oestergaard, Associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01055509     History of Changes
Other Study ID Numbers: UNR-2008037-1
Study First Received: January 22, 2010
Last Updated: June 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Social Adjustment
Quality of life
Recurrence
Hospitalization

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on September 18, 2014