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

ISRCTN	ISRCTN44277627
DOI	https://doi.org/10.1186/ISRCTN44277627
Protocol serial number	RDC01881
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Patients 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) studied	Mental and behavioural disorders: Schizophrenia and other psychoses
Intervention	1. Cognitive remediation therapy 2. Standard care
Intervention type	Other
Primary outcome measure(s)	All 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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	1. 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 criteria	Not provided at time of registration
Date of first enrolment	01/11/2000
Date of final enrolment	01/11/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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