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Completed

NCT Number: NCT01055509

Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Early Intervention Team, Aabenraa, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Adaptation Training

Behavioral

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

Primary outcomes

  1. 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

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Acronym: CAT-Denmark

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2010
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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