Condition category
Mental and Behavioural Disorders
Date applied
20/03/2006
Date assigned
05/05/2006
Last edited
07/12/2010
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

Department of Psychology
P O Box 77
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCYP 97/06

Study information

Scientific title

Acronym

Study hypothesis

Cognitive remediation will improve cognition relative to treatment as usual

Ethics approval

Approved by the South London and Maudsley Ethics Committee as an amendment to a previous application, reference number: 008/99 and the North East London Ethics Committee Oct 02, reference number: P/02/192

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

Schizophrenia

Intervention

Cognitive remediation therapy versus usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Cognitive flexibility (number of categories achieved on the Wisconsin Card Sort Test [WCST] Heaton et al.)
2. Memory (raw score from Digit Span: Wechsler Adult Intelligence Scale-III [WAIS-III] Wechsler,1981)
3. Planning (modified six elements)

Secondary outcome measures

1. Social Behaviour Schedule ([SBS] Wykes and Sturt, 1986) for social functioning
2. Brief Psychiatric Rating Scale (for symptoms) using Lukoff et al. version and Shaffer Factor Scores
3. Quality of Life Scale (for social inclusion)
4. Rosenberg Self Esteem Scale (Rosenberg, 1965)

Overall trial start date

30/09/1998

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of schizophrenia according to the Diagnostic and Statistical Manual, 4th (DSM IV); had a first episode while still a teenager and their duration of illness was 3 years or less
2. Cognitive difficulties in cognitive flexibility (below the 16th centile on the Wisconsin Card Sort Test) and/or memory (poor performance on the Rivermead Behavioural Memory Test)
3. Difficulties in social functioning (at least one problem on the Social Behaviour Scale)
4. Stable medication, in terms of type and dose, for at least one month prior to inclusion

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Evidence of organic brain disorder (e.g. epilepsy)
2. A diagnosis of current substance abuse as defined by the DSM IV
3. A plan to change medication during the trial

Recruitment start date

30/09/1998

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Mental Health Foundation SCYP 97/06, research support account PAH9009

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17524620

Publication citations

  1. Results

    Wykes T, Newton E, Landau S, Rice C, Thompson N, Frangou S, Cognitive remediation therapy (CRT) for young early onset patients with schizophrenia: an exploratory randomized controlled trial., Schizophr. Res., 2007, 94, 1-3, 221-230, doi: 10.1016/j.schres.2007.03.030.

Additional files

Editorial Notes