ISRCTN ISRCTN71067067
DOI https://doi.org/10.1186/ISRCTN71067067
Secondary identifying numbers TP2015012
Submission date
17/07/2015
Registration date
13/08/2015
Last edited
04/04/2016
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
Record updated in last year

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

Contact information

Ms Aisling Ní Chonaire
Public

33 Greycoat Street
Floor 3
London
SW1P 2QF
United Kingdom

Study information

Study designRandomised controlled trial (individual level)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleExamining the effect of Individual Placement and Support for those receiving mental health support on employment and health outcomes.
Study hypothesisDoes 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(s)London - City Road & Hampstead Research Ethics Committee, 05/02/2016, REC ref: 15/LO/2158
ConditionMental health
Intervention1. 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 typeOther
Primary outcome measureThe 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 measuresSecondary 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 study start date15/01/2015
Overall study end date01/12/2018

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participantsBlackpool 1500 (1000 in treatment group), North East : 2800 and West London 2250.
Participant inclusion criteria1. 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 exclusion criteriaThere are no exclusion criteria.
Recruitment start date31/07/2016
Recruitment end date01/12/2017

Locations

Countries of recruitment

  • United Kingdom

Study participating centres

Blackpool Council
FY1 3PS
West London Alliance
W5 2HL
Northumberland County Council
NE61 2EF

Sponsor information

HM Cabinet Office
Government

70 Whitehall
London
SW1A 2AS
United Kingdom

ROR logo "ROR" https://ror.org/01w88hp45

Funders

Funder type

Government

Cabinet Office

No information available

Results and Publications

Intention to publish date01/07/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWe plan on publishing a policy report on our results in Summer 2018.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

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