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 |
| Protocol serial number | ZonMW 945-04-406 |
| Sponsor | University Medical Center Groningen (Netherlands) |
| Funder | ZonMw |
- 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
Scientific
Parnassia & Groninen University
Oude Haagweg 353
Den Haag
2552 ES
Netherlands
| Phone | +31 (0)70 3917622 |
|---|---|
| mark@van-der-gaag.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cost-effectiveness of cognitive behaviour therapy of cognitive behaviour therapy for recent onset schizophrenia patients with persistent and recurrent psychosis. |
| Study acronym | COCOS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Medication compliance |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | All |
| Target sample size at registration | 230 |
| Key inclusion criteria | 1. Schizophrenia patients in the first five years after onset 2. Age 18-64 3. Treatment resistant or recurrent psychosis |
| Key exclusion criteria | 1. IQ<80 2. Severe addiction 3. No competence of Dutch language 4. 4 or more CBT sessions in the last year |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Parnassia & Groninen University
Den Haag
2552 ES
Netherlands
2552 ES
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
