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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Individual Career Management (ICM)
Standard Care
Sponsored by
South London and Maudsley NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety focused on measuring Common mental illness, Supported Employment, Anxiety, Depression, Sickness absence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Southwark Psychological Therapies Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Standard Care (IAPT Therapy) + Individual Career Management (ICM)

Standard Care (IAPT Therapy)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2012
Last Updated
August 19, 2015
Sponsor
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01599481
Brief Title
Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression
Acronym
CAREER
Official Title
Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South London and Maudsley NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Common mental illness, Supported Employment, Anxiety, Depression, Sickness absence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Standard Care (IAPT Therapy) + Individual Career Management (ICM)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard Care (IAPT Therapy)
Intervention Type
Behavioral
Intervention Name(s)
Individual Career Management (ICM)
Other Intervention Name(s)
IPS, Supported Employment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Other Intervention Name(s)
IAPT, CBT
Intervention Description
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Primary Outcome Measure Information:
Title
Length of Competitive Employment
Description
Length of competitive employment during the 6 month study period. The following definition of competitive employment will be used: A job paying at least the national minimum wage. A job located in a mainstream setting not set aside for people with disabilities. A job that is not owned by the ICM service.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Working Hours
Description
Average number of hours worked each week
Time Frame
6 months
Title
Time to Employment
Description
Number of days between baseline date and the employment start date.
Time Frame
6 months
Title
Salary
Description
Average weekly salary over the 6 month period
Time Frame
6 months
Title
Number of Jobs
Description
Number of different jobs held during the 6 month period
Time Frame
6 months
Title
Job Terminations
Description
Number of job terminations over the 6 month period and the reason for each termination
Time Frame
6 months
Title
Other occupational activity
Description
Non-competitive employment (e.g. sheltered work), education, training or volunteering
Time Frame
6 months
Title
Anxiety
Description
Generalised Anxiety Disorder Assessment (GAD 7) score
Time Frame
6 months
Title
Depression
Description
Patient Health Questionnaire (PHQ-9) score
Time Frame
6 months
Title
Social Functioning
Description
Work and Social Adjustment Scale (WSAS)
Time Frame
6 months
Title
Health-related quality of Life
Description
EQ-5D score
Time Frame
6 months
Title
Work-related quality of Life
Description
WRQoL score
Time Frame
6 months
Title
Self Esteem
Description
Rosenberg Self Esteem Scale
Time Frame
6 months
Title
Career Search Efficacy
Description
Career Search Efficacy Scale (CSES) score
Time Frame
6 months
Title
Return to Work Efficacy
Description
Return to Work Self Efficacy Scale (RTW-SE) score
Time Frame
6 months
Title
Productivity
Description
Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Price, CPsychol
Organizational Affiliation
South London and Maudsley NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwark Psychological Therapies Service
City
London
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom

12. IPD Sharing Statement

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