Cognitive remediation for young people with schizophrenia

ISRCTN	ISRCTN75187865
DOI	https://doi.org/10.1186/ISRCTN75187865
Protocol serial number	SCYP 97/06
Sponsor	King's College London (UK)
Funder	Mental Health Foundation SCYP 97/06, research support account PAH9009

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Til Wykes
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Cognitive remediation will improve cognition relative to treatment as usual
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	Cognitive remediation therapy versus usual care
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	30/09/1998
Date of final enrolment	30/09/2004

Department of Psychology

London
SE5 8AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2007		Yes	No