Condition category
Mental and Behavioural Disorders
Date applied
17/07/2015
Date assigned
13/08/2015
Last edited
04/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Individual Placement and Support (IPS) is a model of support which has been tested in secondary care settings (hospitals) for people with severe and enduring mental health conditions. The objective of IPS is to get people back to work as soon as possible and to support them in employment both occupationally and psychologically. This study will test the impact of the intervention (or programme) when applied to people with common mental health conditions. By integrating local employment support (IPS) and clinical support services provided by NHS’ Improving Access to Psychological Therapies (IAPT) among other community services and 'treatments as usual', we hope to demonstrate that significant savings can be achieved as well leading to improvements in the participants health and employment prospects. It has already been tested on a small group (500 employment and support assistance claimants with common mental health conditions) to check what worked and why from the perspectives of claimants, advisers, and providers as well as analysis of measures of distance travelled (including wellbeing, self-efficacy for work, and a clinical measure of mental health). The aim of this study is to assess the programme on a larger number of people and in the field.

Who can participate?
Mostly claimants of Employment and Support Allowance (ESA) although a proportion of Jobseekers’ allowance claimants who are experiencing common mental health conditions will also be included.

What does the study involve?
In each participating area, participants are randomly allocated to one of two groups: treatment and control. The treatment group receive IPS and the control group receive whichever pre-existing alternative type of support is deemed most appropriate (e.g. IAPT, medication, community support).

What are the possible benefits and risks of participating?
Possible benefits include improved mental health and employment. We do not anticipate any risks above what would be expected in daily life

Where is the study run from?
Three areas in the UK: West London, Blackpool and Northumberland.

When is the study starting and how long is it expected to run for?
September 2015 to December 2017

Who is funding the study?
HM Cabinet Office (UK)

Who is the main contact?
Ms Ní Chonaire

Trial website

Contact information

Type

Public

Primary contact

Ms Aisling Ní Chonaire

ORCID ID

Contact details

33 Greycoat Street
Floor 3
London
SW1P 2QF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TP2015012

Study information

Scientific title

Examining the effect of Individual Placement and Support for those receiving mental health support on employment and health outcomes.

Acronym

Study hypothesis

Does an integrated employment and mental health support programme (the IPS model) increase the number of people ceasing to receive unemployment benefits and increase their health outcomes?

Ethics approval

London - City Road & Hampstead Research Ethics Committee, 05/02/2016, REC ref: 15/LO/2158

Study design

Randomised controlled trial (individual level)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Mental health

Intervention

1. The control condition will receive mental health treatment as usual e.g. Improving Access to Psychological Therapies (IAPT), medication, GP support.
2. The treatment group will receive mental health treatment as usual as well as Individual Placement and Support (IPS) which is an integrated employment support service.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The primary outcome measure will involve whether the individuals are off unemployment benefits at 3 and 6 months after entering the intervention. This will be collected via Department for Work and Pensions administrative data.

Secondary outcome measures

Secondary outcome measures will include sub sample analysis (e.g. those who are long-term unemployed, those with higher levels of mental health difficulties, gender effects). In addition, for a sub sample of participants we will use mental health as an outcome measure (using PHQ9 and GAD7). We will also include administrative data from HSCIC to measure proxy health outcomes (e.g. hospital admissions, prescriptions). For data collected administratively (i.e. demographics data and HSCIC data), these will be collected 3 and 6 months after entry into the trial.

Overall trial start date

15/01/2015

Overall trial end date

01/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants will be required to be in receipt of unemployment benefits.
2. Participants will be required to score within the mild to severe categorisation of the Patient Health Questionnaire 9 and the Generalized Anxiety Disorder 7.

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Blackpool 1500 (1000 in treatment group), North East : 2800 and West London 2250.

Participant exclusion criteria

There are no exclusion criteria.

Recruitment start date

31/07/2016

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blackpool Council
FY1 3PS

Trial participating centre

West London Alliance
W5 2HL

Trial participating centre

Northumberland County Council
NE61 2EF

Sponsor information

Organisation

HM Cabinet Office

Sponsor details

70 Whitehall
London
SW1A 2AS
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Cabinet Office

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan on publishing a policy report on our results in Summer 2018.

Intention to publish date

01/07/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/04/2016: Ethics approval information added, recruitment start date changed from 07/09/2015 to 31/07/2016.