Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01055509
First received: January 22, 2010
Last updated: June 6, 2011
Last verified: June 2011
History of Changes

January 22, 2010
June 6, 2011
January 2009
April 2011   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01055509 on ClinicalTrials.gov Archive Site
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.
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 ]
Not Provided
Not Provided
 
Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia
Effectiveness of Cognitive Adaptation Training Applied to Cognitive Impairment in Schizophrenia - A Randomised Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
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
  • Experimental: Cognitive Adaptation Training
    Cognitive adaptation training and treatment as usual
    Intervention: Behavioral: Cognitive Adaptation Training
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
164
September 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01055509
UNR-2008037-1
Yes
Jens Peter Hansen, Unit of Nursing Research
University of Southern Denmark
Not Provided
Principal Investigator: Lise Hounsgaard, PhD Research Unit of Nursing
University of Southern Denmark
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP