- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599481
Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression (CAREER)
Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, SE5 8AZ
- Southwark Psychological Therapies Service
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Other Names:
|
|
Active Comparator: Control
Standard Care (IAPT Therapy)
|
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Other Names:
|
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:
|
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
|
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Salary
Time Frame: 6 months
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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
|
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Job Terminations
Time Frame: 6 months
|
Number of job terminations over the 6 month period and the reason for each termination
|
6 months
|
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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
|
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Depression
Time Frame: 6 months
|
Patient Health Questionnaire (PHQ-9) score
|
6 months
|
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Social Functioning
Time Frame: 6 months
|
Work and Social Adjustment Scale (WSAS)
|
6 months
|
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Health-related quality of Life
Time Frame: 6 months
|
EQ-5D score
|
6 months
|
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Work-related quality of Life
Time Frame: 6 months
|
WRQoL score
|
6 months
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Self Esteem
Time Frame: 6 months
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Rosenberg Self Esteem Scale
|
6 months
|
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Career Search Efficacy
Time Frame: 6 months
|
Career Search Efficacy Scale (CSES) score
|
6 months
|
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Return to Work Efficacy
Time Frame: 6 months
|
Return to Work Self Efficacy Scale (RTW-SE) score
|
6 months
|
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Productivity
Time Frame: 6 months
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Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Claire Price, CPsychol, South London and Maudsley NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLAM-ICM-1011
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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