Condition category
Mental and Behavioural Disorders
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
12/08/2014
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
Box PO81
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5661

Study information

Scientific title

An exploratory two-group randomised controlled trial of computerised cognitive remediation therapy (CRT) and treatment as usual versus treatment as usual alone in schizophrenia patients

Acronym

CIRCUITS-3

Study hypothesis

Cognitive difficulties are a limiting factor on the functional and quality of life outcomes for people with schizophrenia. Cognitive remediation therapy (CRT) is a psychological therapy shown to improve these thinking skills. Currently therapy involves a considerable amount of therapist time but a new development, computerised CRT (CIRCuiTS), may reduce the need for direct individual face to face therapy so that more people can access it. However, the efficacy of this form of therapy has yet to be determined.

This trial is an exploratory two-group randomised controlled trial (RCT): CIRCuiTS and treatment as usual (TAU) compared to TAU. Outcomes are measured at weeks 0, 12, 26. Participants are independently randomised and raters blind to group allocation. Primary outcomes are measured in three cognitive domains: long-term memory, working memory and executive function. Secondary outcomes include social functioning, service use and self-esteem.

Ethics approval

Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committees, 01/07/2008, ref: 08/H0807/26

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details in the interventions section below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Schizophrenia; Disease: Schizophrenia

Intervention

CIRCuiTS is a new computerised cognitive remediation package for schizophrenia that aims to improve attention, memory and cognitive flexibility. CIRCuiTS is an eLearning platform that guides participants through a series of mental exercises with the goal of strategy formation. This approach is known to facilitate generalisation to everyday function. There are 40 sessions of therapy taking place up to 5 times a week.

Follow-up length: 3 months
Study entry: single randomisation only

Contact details for Patient Information Material:
Ms Sasha Whaley
Institute of Psychiatry
King's College London
De Crespigny Park
London SE5 8AF
United Kingdom
T: +44 (0)20 7848 0686 ext. 5001

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cognitive test battery, measured at timepoint 1 (0 weeks), 2 (12 weeks) and 3 (26 weeks)

Secondary outcome measures

1. Community functioning, measured at timepoint 1, 2 and 3
2. Psychiatric symptoms, measured at timepoint 1, 2 and 3

Overall trial start date

01/04/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be entered into the study if they have:
1. A diagnosis of schizophrenia
2. Have been in touch with the mental health services for at least one year
3. Aged between 17 and 65 years old, either sex
4. Have a known cognitive deficit (poor performance in memory [digit span] and/or cognitive flexibility [WCST or Hayling Sentence Completion Test] in addition to poor social functioning [score of 2 or more on Social Behaviour Schedule])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Plan to change their medication during the therapy phase of the study
2. Known substance dependence
3. Evidence of an organic cause to their cognitive difficulties (e.g. history of head injury)

Recruitment start date

01/04/2010

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Trust (UK)

Sponsor details

Clinical Treatment Centre
1st Floor
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.slam.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

Publication citations

Additional files

Editorial Notes