Contact information
Type
Scientific
Primary contact
Prof Til Wykes
ORCID ID
Contact details
Institute of Psychiatry
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0596
t.wykes@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01881
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mental and behavioural disorders: Schizophrenia and other psychoses
Intervention
1. Cognitive remediation therapy
2. Standard care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2000
Overall trial end date
01/11/2003
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2000
Recruitment end date
01/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17470957
Publication citations
-
Results
Wykes T, Reeder C, Landau S, Everitt B, Knapp M, Patel A, Romeo R, Cognitive remediation therapy in schizophrenia: randomised controlled trial., Br J Psychiatry, 2007, 190, 421-427, doi: 10.1192/bjp.bp.106.026575.