Plain English Summary
Background and study aims
Having a job is important to a person’s identity and self-esteem. People who are unemployed are more likely to suffer from a wide range of mental and physical ill health as a consequence. It is widely recognised that people with severe mental health problems (such as schizophrenia or bipolar disorder) benefit socially, psychologically and economically from being employed. Government policy is geared towards encouraging people into work, and in recent years some of the barriers in the benefits system have been overcome. We have also learned about the most effective ways to support people with severe mental health problems who wish to work. An approach called Individual Placement and Support (IPS) is recommended by Department of Health guidelines. However, employment rates remain low, in Nottinghamshire no higher than 15%. Traditional vocational rehabilitation involved people first being treated to control their symptoms followed by training or work experience in a sheltered environment. However, in IPS clinical treatment and employment support are integrated and occur at the same time. The focus here is to help people get a job corresponding with their interests and then providing all the support they need for as long as necessary. This study aims to increase the number of people with mental health problems who are in paid work in Nottinghamshire. Besides boosting the supply of high-quality employment support, it will look at alternative ways of providing this, both with and without work-focused psychological counseling.
Who can participate?
Participants of working age (18-65) will be recruited from the caseloads of community mental health teams (CMHTs) and early intervention in psychosis (EIP) teams in Nottinghamshire.
What does the study involve?
Participants are randomly allocated to receive either IPS alone or IPS with work-focused psychological support, to see which approach has the best outcome. Participants complete questionnaires at the start of the study and after 6 and 12 months, and are also contacted via phone after 3, 9 and 18 months.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
NIHR CLAHRC Nottinghamshire (UK).
When is the study starting and how long is it expected to run for?
August 2010 to July 2013.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof. Justine Schneider
Justine.Schneider@nottingham.ac.uk
Trial website
http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/mental-health_4
Contact information
Type
Scientific
Primary contact
Prof Justine Schneider
ORCID ID
Contact details
NIHR CLAHRC Nottinghamshire
Lincolnshire and Derbyshire
The Sir Colin Campbell Building
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
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Justine.Schneider@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10017
Study information
Scientific title
Individual placement and support for people with severe mental health problems: an implementation study of IPS with and without individual counselling as access routes to paid employment
Acronym
Study hypothesis
Psychological therapy as an adjunct to IPS will prove more successful in helping people with schizophrenia and related disorders into work than IPS alone
Ethics approval
Derbyshire Research Ethics Committee, 28/04/2010, ref: 10/H0401/18
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 contact Ms Athfah Akhtar (athfah.akhtar@nottingham.ac.uk) to request a patient information sheet
Condition
Severe mental Illness
Intervention
Individual Placement and Support (IPS) alone versus IPS + work - focussed psychological therapy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The total number of working hours completed within six months of entering the trial. We will measure this by monitoring job start and end dates and paid hours worked per week.
2. Type of employment and wage levels will be recorded
Secondary outcome measures
1. Changes in self-esteem, experienced stigma, work limitations, quality of life and changes in costs, service utilisation, income and related matters
2. We will also monitor other vocational activities such as education, training and volunteering that participants may have done while looking for paid work
Overall trial start date
01/08/2010
Overall trial end date
01/07/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Community Mental Health Teams and Early Intervention in Psychosis teams' clients of working age (18-60)
2. People with dual diagnosis (substance use problems and mental health issues) will also be included
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56 people to be recruited to the trial
Participant exclusion criteria
1. Inpatients at the time of invitation to participate
2. People currently in work or in education and not wishing to work
3. Individuals who are unwilling or unable to give informed consent
4. Participants who are already receiving cognitive based therapy (CBT)
Recruitment start date
01/08/2010
Recruitment end date
01/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NIHR CLAHRC Nottinghamshire
Nottingham
NG7 2TU
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)
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