Refining Individual Placement and Support (IPS-LITE)

ISRCTN	ISRCTN28876952
DOI	https://doi.org/10.1186/ISRCTN28876952
Secondary identifying numbers	Protocol V.2 - 09/10/2009

Submission date: 22/12/2009
Registration date: 06/04/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tom Burns
Scientific

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

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	IPS-LITE Trial
Study objectives	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(s)	IOW, Portsmouth & SE Hampshire Research Ethics Committee, 22/09/2009, ref: 09/H0501/53
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2009
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Key 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
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX3 7JX
United Kingdom

Sponsor information

Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website	http://www.obmh.nhs.uk/
"ROR"	https://ror.org/04c8bjx39

Funders

Funder type

Government

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)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2015		Yes	No

Editorial Notes

04/10/2017: Publication reference added.