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
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