The effectiveness of cognitive remediation therapy (CRT) for patients with schizophrenia

ISRCTN ISRCTN44277627
DOI https://doi.org/10.1186/ISRCTN44277627
Secondary identifying numbers RDC01881
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
08/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Til Wykes
Scientific

Institute of Psychiatry
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 7848 0596
Email t.wykes@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPatients with schizophrenia are not only concerned about the positive symptoms of the disorder but are also distressed by the cognitive deficits associated with the disorder. Attention, concentration and memory are also associated with poor outcome with those patients with the severest deficits being in need of high levels of service support. The therapy under investigation in this trial was designed to have a direct effect on cognition which will then impact on daily functioning and perceived quality of life. The project is a randomised controlled trial of this innovative treatment, cognitive remediation therapy (CRT). Previous studies have shown that CRT has significant effects on cognitive functioning in patients with severe cognitive difficulties and that when this improvement reaches a generalised threshold there are effects on social functioning. The purpose of this trial is to widen its application to those whose cognitive performance is not so poor, to test predictive factors for outcome and assess the effects of therapy on a specific skill, shopping. In addition, the trial contains a health economic aspect which will allow cost-effectiveness to be assessed. The results will provide further detail on the effects and applicability of this treatment to the wider population of people with schizophrenia and will aid its further implementation into the NHS.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and behavioural disorders: Schizophrenia and other psychoses
Intervention1. Cognitive remediation therapy
2. Standard care
Intervention typeOther
Primary outcome measureAll have been chosen for their good reliability and validity and use in this population of patients.
i. Cognitive outcomes - the results of neuropsychological tests (see plan of investigation for details)
ii. Social Behaviour - DEX independent questionnaire, Social Behaviour Schedule and Test of Grocery Skills
iii. Symptom outcome - PANNS
iv. Quality of Life - MANSA
v. Self esteem - Rosenberg self esteem schedule
vi. Service contact - Client Service Receipt Inventory
Process measures - These forms allow ratings of the level of performance achieved in each session, with reference to the individual tasks carried out in the session as well as at the end of each module. They have established inter-rater reliability as well as face validity.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2000
Completion date01/11/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. In contact with local psychiatric services for at least two years
2. Diagnosis of schizophrenia based on The Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSMIV)
3. Evidence of some cognitive difficulties (rated as poor on either memory or cognitive flexibility)
4. Evidence of social functioning problems (scored on at least one problem on Social Behaviour Scale)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2000
Date of final enrolment01/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2007 Yes No