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Clinical Trial Summary

The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a model of supported employment (the Individual Career Management (ICM) model) designed to help people with common mental illness return to work.


Clinical Trial Description

The design of the study is a randomised controlled trial of two groups in a natural setting (intervention group vs control group). The primary outcome is paid employment. Standard care for all participants is a package of psychological therapy (IAPT). The intervention is an additional package of employment support (ICM) delivered alongside standard care.

The intervention group and control group will both receive standard care. The intervention group will receive ICM support in addition to standard care and the control group will be given details of other employment programmes in the local area, in line with current IAPT practice. The control period will last six months. There will be no fewer than 184 participants in the study (92 in each arm).

The study will take place at the Southwark Psychological Therapies Service at the SLaM NHS Foundation Trust. Patients that meet the inclusion criteria will be invited to attend an interview where written informed consent and baseline measures will be obtained. The participant will then be randomly assigned to either the intervention or control group. All participants will be invited to attend a second interview at the end of a six month period where followup measures will be taken. If the intervention is available at this time, control group participants may then be offered the opportunity to receive it.

A randomised controlled trial of supported employment for people with common mental health problems has never been carried out in the UK, therefore this study will be the first of its kind. The results will help to determine if ICM is an effective and costeffective service and will provide the foundations for further research in this area. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01599481
Study type Interventional
Source South London and Maudsley NHS Foundation Trust
Contact
Status Completed
Phase Phase 2
Start date October 2011
Completion date April 2014

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