Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor David Kingdon

ORCID ID

Contact details

1st Floor
University Department
Department of Psychiatry
Royal South Hants Hospital
Brintons Terrace
Southampton
S014 0YG
United Kingdom
+44 023 8082 5054
dgk@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0230111580

Study information

Scientific title

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Severe mental illness

Intervention

Patients 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary endpoint would be a 20% increase in patients in employment in the intervention group.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

14/06/2002

Overall trial end date

14/06/2004

Reason abandoned

Change in trial objectives

Eligibility

Participant inclusion criteria

Mental 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. 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)

Recruitment start date

14/06/2002

Recruitment end date

14/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

West Hampshire Consortium (UK)

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

Not published

Publication citations

Additional files

Editorial Notes