Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes