Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Mental Health Care Services Drenthe (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes