Condition category
Mental and Behavioural Disorders
Date applied
22/12/2009
Date assigned
06/04/2010
Last edited
27/05/2015
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

Prof Tom Burns

ORCID ID

Contact details

Department of Psychiatry
University of Oxford
Warneford Hospital
Warneford Lane
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol V.2 - 09/10/2009

Study information

Scientific title

Is brief Individual Placement and Support (IPS-LITE) as effective as open-ended Individual Placement and Support (IPS) in obtaining employment for individuals with psychiatric disorders? A randomised controlled trial

Acronym

IPS-LITE Trial

Study hypothesis

Modified IPS model (IPS-LITE), with its clearer time-frame, will return an equal or greater proportion of patients to employment compared to standard IPS. The primary outcome is return to open employment for at least one day.

Ethics approval

IOW, Portsmouth & SE Hampshire Research Ethics Committee, 22/09/2009, ref: 09/H0501/53

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Clinically established diagnosis of mental illness

Intervention

Eligible participants will be identified from a newly established IPS service during the IPS service eligibility assessment. Patients will enter the study in the same time when they enter the service.

After obtaining of the written consent the baseline interview will be administered by research assistant. Recruitment period will last 15 months with follow-up of 18 months and assessments at baseline, 9 months and 18 months. The interviews will consist of appropriate validated and standardised questionnaires. Data will be obtained from patients' medical records. After 18-months of trial the IPS service continues as usual.

After the baseline interview participants will be randomised to either IPS-LITE (intervention group) or IPS standard (control group).

Control group:
IPS workers are integrated into the secondary mental health team and have a maximum caseload of 25 clients. Clients usually remain in the care of the MH team and the approach is to ascertain job preferences from motivated clients and, through local knowledge of employers, help them identify and obtain open employment without prolonged preliminary assessment or training. IPS workers continue to support client and employer indefinitely according to need.

Intervention group:
IPS-LITE follows exactly the same principles as IPS, including integration with the MH team, maximum caseload and procedures for job search and support. However it restricts the period of engagement. Clients unplaced after 9 months will be discharged back to the MH team who can re-refer if clinical circumstances change (re-referral will be treated as an outcome, not as new study subjects). Engagement and support will be reduced when clients have been continuously employed for 13 weeks, handing back to the MH team at 16 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Worked for at least one day.

All outcomes are measured at 9 months and 18 months after the baseline assessment.

Secondary outcome measures

1. Worked for at least 13 weeks
2. Number of days worked
3. Number of hours worked
4. Job tenure (length of longest job)
5. Time to first job
6. Client disengagement from IPS
7. Hospitalisation (Y/N)
8. Number of days hospitalised

All outcomes are measured at 9 months and 18 months after the baseline assessment.

Overall trial start date

01/09/2009

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 60 years, either sex
2. Clinically established diagnosis of mental illness
3. Enhanced care programme approach (CPA)
4. Unemployed for a minimum of six months
5. Declared wish to obtain open employment
6. Written and informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Incapacity to give informed consent (e.g. advanced dementia or mental disorder too severe to give informed consent)
2. Incapacity to communicate in English

Recruitment start date

01/09/2009

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)

Sponsor details

Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
United Kingdom

Sponsor type

Government

Website

http://www.obmh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme funding pending as of 23/02/2010 (ref: PB-PG-0909-20029)

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