Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
30/07/2008
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

Dr M van der Gaag

ORCID ID

Contact details

Parnassia & Groninen University
Oude Haagweg 353
Den Haag
2552 ES
Netherlands
+31 (0)70 3917622
mark@van-der-gaag.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMW 945-04-406

Study information

Scientific title

Acronym

COCOS

Study hypothesis

To determine the cost-effectiveness of CBT compared to care as usual in patients with a recent onset of schizophrenia, who suffer from persistent and recurrent symptoms of psychosis.

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

Not Specified

Patient information sheet

Condition

Schizophrenia

Intervention

Please note that, as of 30/07/2008, the end date of this trial has been updated from 01/12/2007 to 01/04/2008.

Interventions:
1. CBT by a cognitive therapist and a nurse therapist
2. CAU

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Days functioning in normal range based on PSYRAYS and SFS: minimal suffering and functional restrictions by delusions and/or hallucinations and SFS normal social functioning.

Secondary outcome measures

1. Medication compliance
2. Number of relapses
3. Psychiatric symptoms
4. Quality of life

Overall trial start date

01/12/2004

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Schizophrenia patients in the first five years after onset
2. Age 18-64
3. Treatment resistant or recurrent psychosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

230

Participant exclusion criteria

1. IQ<80
2. Severe addiction
3. No competence of Dutch language
4. 4 or more CBT sessions in the last year

Recruitment start date

01/12/2004

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Parnassia & Groninen University
Den Haag
2552 ES
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (Netherlands)

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

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