Cost-effectiveness of cognitive behaviour therapy of cognitive behaviour therapy for recent onset schizophrenia patients with persistent and recurrent psychosis.

ISRCTN ISRCTN57292778
DOI https://doi.org/10.1186/ISRCTN57292778
Secondary identifying numbers ZonMW 945-04-406
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M van der Gaag
Scientific

Parnassia & Groninen University
Oude Haagweg 353
Den Haag
2552 ES
Netherlands

Phone +31 (0)70 3917622
Email mark@van-der-gaag.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleCost-effectiveness of cognitive behaviour therapy of cognitive behaviour therapy for recent onset schizophrenia patients with persistent and recurrent psychosis.
Study acronymCOCOS
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSchizophrenia
InterventionPlease 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 typeOther
Primary outcome measureDays 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 measures1. Medication compliance
2. Number of relapses
3. Psychiatric symptoms
4. Quality of life
Overall study start date01/12/2004
Completion date01/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit64 Years
SexBoth
Target number of participants230
Key inclusion criteria1. Schizophrenia patients in the first five years after onset
2. Age 18-64
3. Treatment resistant or recurrent psychosis
Key exclusion criteria1. IQ<80
2. Severe addiction
3. No competence of Dutch language
4. 4 or more CBT sessions in the last year
Date of first enrolment01/12/2004
Date of final enrolment01/04/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Parnassia & Groninen University
Den Haag
2552 ES
Netherlands

Sponsor information

University Medical Center Groningen (Netherlands)
Hospital/treatment centre

Hanzeplein 1
Groningen
9713 GZ
Netherlands

ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Research organisation

ZonMw
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2011 07/01/2021 Yes No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.