Prodromal symptoms and early intervention to prevent a relapse
| ISRCTN | ISRCTN17350364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17350364 |
| Protocol serial number | N/A |
| Sponsor | Mental Health Care Services Drenthe (Netherlands) |
| Funders | Netherlands Organisation for Health Research and Development (ZonMw), Support Foundation (Stichting tot Steun) (Netherlands), Netherlands Care Cooperative (Zorgcoöperatie Nederland [formerly: De Open Ankh]) (Netherlands), The Per V. Petersen Foundation (Netherlands), National Foundation of Mental Health Care (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 18/08/2009
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Arends
Scientific
Scientific
Department of Psychotic Disorders
Mental Health Care Services Drenthe
P.O. Box 30.007
Assen
9400 RA
Netherlands
| Phone | +31 (0)592 334883 |
|---|---|
| Johan.Arends@GGZDrenthe.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised single blind active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Could early treatment of prodromal symptoms prevent or postpone a psychotic relapse in schizophrenia? |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Schizophrenia, Schizophreniform disorder |
| Intervention | The Symptom Management Module (SMM), one of the independent living skills modules developed by the Los Angeles rehabilitation research group, is a psychosocial intervention to improve the capability of patients with schizophrenia to detect early warning signs (EWS) of a psychosis and to teach the patients to manage them. Two treatment conditions (symptom management module [N = 46] versus self monitoring [N = 52]) and a comparison group (treatment as usual [N = 49]) in patients with schizophrenia or related psychotic disorders. |
| Intervention type | Other |
| Primary outcome measure(s) |
Occurrence of a psychotic relapse: a worsening of at least two points on the CGI as assessed by psychiatrist and verified by researcher by a PANSS-interview within a week. |
| Key secondary outcome measure(s) |
1. Hospitalisation |
| Completion date | 01/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 147 |
| Key inclusion criteria | 1. ICD-10 diagnosis of schizophrenia (F20) or schizoaffective disorder (F25) 2. A remitted state established by no more than one score of 4 on the positive scale of the PANSS 3. Necessary skills in Dutch language to undergo a training in Dutch |
| Key exclusion criteria | Substance abuse |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 01/01/2002 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Psychotic Disorders
Assen
9400 RA
Netherlands
9400 RA
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 |
