Condition category
Nervous System Diseases
Date applied
14/05/2012
Date assigned
21/06/2012
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Supported employment refers to services that help people with disabilities, including mental health conditions, to get a job and stay in work. The main aim of this study is to find out whether the Individual Career Management (ICM) intervention is effective at helping people with anxiety and/or depression to get a job and stay in work. We also want to find out whether the ICM intervention is also effective at encouraging participation in education, training or volunteering, reducing severity of anxiety and/or depression, improving quality of life, and increasing self-esteem. A further aim is to find out whether the ICM intervention is more cost-effective in comparison to standard care.

Who can participate?
People aged 18-65 with anxiety and/or depression who have been unemployed or off sick for at least two weeks and are interested in returning to work.

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives standard care - a course of psychological therapy delivered by the Southwark Psychological Therapies Service. The other group receives standard care and also ICM support, which includes career counselling, motivational coaching, education and training support.

What are the possible benefits and risks of participating?
Participants get a 50% chance of receiving the ICM intervention that is currently not available anywhere else in the NHS. They may also feel good about contributing to research that could help improve services for future patients with anxiety or depression. There are few risks involved in this study. It is minimal risk of harm to the participant as the intervention is voluntary and is not designed to put participants under any additional pressure or danger. The main burden for participants will be giving up their time to attend the interviews which will include the completion of questionnaires.

Where is the study run from?
All participants will be recruited from the Southwark Psychological Therapies Service, part of the South London and Maudsley NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
October 2011 to October 2013.

Who is funding the study?
South London and Maudsley NHS Foundation Trust (UK).

Who is the main contact?
Claire Price
claire.price@slam.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Claire Price

ORCID ID

Contact details

South London and Maudsley NHS Foundation Trust
Maudsley Hospital
Main Entrance Building
1st Floor
Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 3228 3221
claire.price@slam.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01599481

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness and cost effectiveness of Individual career management for people with anxiety and depression: a randomised controlled trial

Acronym

CAREER

Study hypothesis

Is the Individual Career Management (ICM) intervention effective in helping people with anxiety and/or depression to obtain and retain in competitive employment?

Ethics approval

NRES Research Ethics Committee Harrow, 12/08/2011, ref: 11/LO/0765

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anxiety and depression disorders

Intervention

Intervention group: 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.

Control group participants will receive standard care (IAPT therapy) only.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The length of competitive employment during the period. The following definition of competitive employment will be used:

1. 1. A job paying at least the national minimum wage
1. 2. A job located in a mainstream setting not set aside for people with disabilities
1. 3. A job that is not owned by the ICM service

Secondary outcome measures

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

Measured 6 months from the date of entry to the study.

Overall trial start date

01/10/2011

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Must be either unemployed or off sick for at least two weeks if employed at the time of entry to the study
2. Must be legally allowed to work in the UK
3. Must be between the age of 18 - 65 for men, and 18 - 60 for women (based on UK retirement age)
4. Must have received an Improving Access to Psychological Therpaies (IAPT) assessment and been offered psychological therapy
5. Must not have been receiving therapy for more than one month
6. Must be interested in obtaining competitive employment
7. Must have given full written consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

184 (92 in each arm)

Participant exclusion criteria

1. People who are employed and attending work or off sick for less than two weeks at the time of entry to the study
2. People who do not have the legal right to work in the UK
3. People who have not yet received an IAPT assessment
4. People who have received an IAPT assessment but not eligible for psychological therapy
5. People who have been receiving therapy for more than one month
6. People who are not interested in obtaining competitive employment
7. People who do not give written consent or who lack mental capacity to give consent at the time of the study

Recruitment start date

01/10/2011

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Southwark Vocational Service (UK)

Sponsor details

South London and Maudsley NHS Foundation Trust
Maudsley Hospital
Main Entrance Building
Ground Floor
Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 3228 3221
claire.price@slam.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

South London and Maudsley NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes