Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression (CAREER)

August 19, 2015 updated by: Claire Price, South London and Maudsley NHS Foundation Trust

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SE5 8AZ
        • Southwark Psychological Therapies Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • People who have not yet received an IAPT assessment
  • People who have received an IAPT assessment but not eligible for psychological therapy
  • People who have been receiving therapy for more than one month
  • People who are not interested in obtaining competitive employment
  • People who do not give written consent or who lack mental capacity to give consent at the time of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Standard Care (IAPT Therapy) + Individual Career Management (ICM)
The intervention will be Individual Career Management (ICM) support for a six month period. ICM consists of individually tailored support to help an individual to obtain and retain in employment. ICM follows the seven principles of supported employment (often referred to an Individual Placement and Support), but includes the additional principles of career counselling, motivational coaching, education and training support, and specialist job retention support. The length and frequency of ICM support sessions is determined by the needs of the client.
Other Names:
  • IPS
  • Supported Employment
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Other Names:
  • CBT
  • IAPT
Active Comparator: Control
Standard Care (IAPT Therapy)
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Other Names:
  • CBT
  • IAPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Hours
Time Frame: 6 months
Average number of hours worked each week
6 months
Time to Employment
Time Frame: 6 months
Number of days between baseline date and the employment start date.
6 months
Salary
Time Frame: 6 months
Average weekly salary over the 6 month period
6 months
Number of Jobs
Time Frame: 6 months
Number of different jobs held during the 6 month period
6 months
Job Terminations
Time Frame: 6 months
Number of job terminations over the 6 month period and the reason for each termination
6 months
Other occupational activity
Time Frame: 6 months
Non-competitive employment (e.g. sheltered work), education, training or volunteering
6 months
Anxiety
Time Frame: 6 months
Generalised Anxiety Disorder Assessment (GAD 7) score
6 months
Depression
Time Frame: 6 months
Patient Health Questionnaire (PHQ-9) score
6 months
Social Functioning
Time Frame: 6 months
Work and Social Adjustment Scale (WSAS)
6 months
Health-related quality of Life
Time Frame: 6 months
EQ-5D score
6 months
Work-related quality of Life
Time Frame: 6 months
WRQoL score
6 months
Self Esteem
Time Frame: 6 months
Rosenberg Self Esteem Scale
6 months
Career Search Efficacy
Time Frame: 6 months
Career Search Efficacy Scale (CSES) score
6 months
Return to Work Efficacy
Time Frame: 6 months
Return to Work Self Efficacy Scale (RTW-SE) score
6 months
Productivity
Time Frame: 6 months
Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claire Price, CPsychol, South London and Maudsley NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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