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
Scientific
Institute of Psychiatry
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0596 |
|---|---|
| t.wykes@iop.kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2000 |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
