ISRCTN ISRCTN98775322
DOI https://doi.org/10.1186/ISRCTN98775322
Secondary identifying numbers N0230111580
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
29/07/2008
Recruitment status
Stopped
Overall study status
Stopped
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

Professor David Kingdon
Scientific

1st Floor, University Department
Department of Psychiatry
Royal South Hants Hospital
Brintons Terrace
Southampton
S014 0YG
United Kingdom

Phone +44 023 8082 5054
Email dgk@soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study objectivesTo assess whether vocational advisers improve the occupational status of people with severe mental illness who express a desire to find work when asked by their mental health care coordinator.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSevere mental illness
InterventionPatients will be asked at Care Programme Approach reviews if they wish to seek part-time or full-time employment. Those who do will be included in the study up to a limit of 100 patients. They will be randomised to control group (advice and training) or intervention group (direct assistance from vocational adviser) stratified by the local mental health team. The randomisation will be done from sealed envelopes kept independently from the study participants.

Added 29 July 2008: the trial was stopped due to a change in objectives.
Intervention typeOther
Primary outcome measurePrimary endpoint would be a 20% increase in patients in employment in the intervention group.
Secondary outcome measuresNot provided at time of registration
Overall study start date14/06/2002
Completion date14/06/2004
Reason abandoned (if study stopped)Change in trial objectives

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants100
Key inclusion criteriaMental health patients who are currently being seen by defined Locality Mental Health Teams (LMHTs) will be screened at Care Programme Approach review meeting and a total of 108 patients will be recruited to allow for an 80% chance of finding a difference of 20% between the groups.

Inclusion criteria:
1. Diagnosis of schizophrenia, affective or severe neurotic disorder duration - at least one year
2. No regular paid employment in past year
3. Gives informed consent to participation in study
Key exclusion criteria1. Primary diagnosis of substance abuse (but not excluding people with dual diagnoses of substance misuse and severe mental illness)
2. Primary diagnosis of organic mental illness (eg dementia)
Date of first enrolment14/06/2002
Date of final enrolment14/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

1st Floor, University Department
Southampton
S014 0YG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

West Hampshire Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan