Prodromal symptoms and early intervention to prevent a relapse

ISRCTN	ISRCTN17350364
DOI	https://doi.org/10.1186/ISRCTN17350364
Secondary identifying numbers	N/A

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

Dr J. Arends
Scientific

Department of Psychotic Disorders
Mental Health Care Services Drenthe
P.O. Box 30.007
Assen
9400 RA
Netherlands

Phone	+31 (0)592 334883
Email	Johan.Arends@GGZDrenthe.nl

Study design	Multicentre randomised single blind active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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	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 study start date	01/01/1997
Completion date	01/01/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Department of Psychotic Disorders

Assen
9400 RA
Netherlands

Mental Health Care Services Drenthe (Netherlands)
Hospital/treatment centre

Department of Psychotic Disorders
P.O. Box 30.007
Assen
9400 RA
Netherlands

"ROR"	https://ror.org/0107rkg57

Research organisation

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

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Support Foundation (Stichting tot Steun) (Netherlands)

No information available

Netherlands Care Cooperative (Zorgcoöperatie Nederland [formerly: De Open Ankh]) (Netherlands)

No information available

The Per V. Petersen Foundation (Netherlands)

No information available

National Foundation of Mental Health Care (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan