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Clinical Trials/NCT01599481
NCT01599481
Completed
Phase 2

Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial

South London and Maudsley NHS Foundation Trust1 site in 1 country261 target enrollmentOctober 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Anxiety
Sponsor
South London and Maudsley NHS Foundation Trust
Enrollment
261
Locations
1
Primary Endpoint
Length of Competitive Employment
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
April 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claire Price

Employment & Social Inclusion Manager

South London and Maudsley NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Must be either unemployed or off sick for at least two weeks if employed at the time of entry to the study
  • Must be legally allowed to work in the UK
  • Must be between the age of 18-65 for men, and 18-60 for women (based on UK retirement age)
  • Must have received an IAPT assessment and been offered psychological therapy
  • Must not have been receiving therapy for more than one month
  • Must be interested in obtaining competitive employment
  • Must have given full written consent to participate in the study
  • Exclusion criteria:
  • People who are employed and attending work or off sick for less than two weeks at the time of entry to the study
  • People who do not have the legal right to work in the UK

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Length of Competitive Employment

Time Frame: 6 months

Length of competitive employment during the 6 month study period. The following definition of competitive employment will be used: 1. A job paying at least the national minimum wage. 2. A job located in a mainstream setting not set aside for people with disabilities. 3. A job that is not owned by the ICM service.

Secondary Outcomes

  • Return to Work Efficacy(6 months)
  • Working Hours(6 months)
  • Career Search Efficacy(6 months)
  • Health-related quality of Life(6 months)
  • Work-related quality of Life(6 months)
  • Self Esteem(6 months)
  • Time to Employment(6 months)
  • Number of Jobs(6 months)
  • Anxiety(6 months)
  • Depression(6 months)
  • Salary(6 months)
  • Job Terminations(6 months)
  • Other occupational activity(6 months)
  • Social Functioning(6 months)
  • Productivity(6 months)

Study Sites (1)

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