Contact information
Type
Scientific
Primary contact
Dr J. Arends
ORCID ID
Contact details
Department of Psychotic Disorders
Mental Health Care Services Drenthe
P.O. Box 30.007
Assen
9400 RA
Netherlands
+31 (0)592 334883
Johan.Arends@GGZDrenthe.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Could early treatment of prodromal symptoms prevent or postpone a psychotic relapse in schizophrenia?
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
1. Hospitalisation
2. Psychopathology
Overall trial start date
01/01/1997
Overall trial end date
01/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
147
Participant exclusion criteria
Substance abuse
Recruitment start date
01/01/1997
Recruitment end date
01/01/2002
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Psychotic Disorders
Assen
9400 RA
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Support Foundation (Stichting tot Steun) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Care Cooperative (Zorgcoöperatie Nederland [formerly: De Open Ankh]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Per V. Petersen Foundation (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Foundation of Mental Health Care (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (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
Basic results (scientific)
Publication list