AnxietyPhase 2CAREERNCT01599481
Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression
A Phase 2 study testing Individual Career Management (ICM) in people with Anxiety and Depression, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Individual Career Management (ICM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southwark Psychological Therapies Service
London, SE5 8AZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Individual Career Management (ICM), Standard Care
- Keywords
- Common mental illness, Supported Employment, Anxiety, Depression, Sickness absence
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Career Management (ICM)Behavioural
Also called IPS, Supported Employment
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.
Standard CareBehavioural
Also called IAPT, CBT
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard Care (IAPT Therapy) + Individual Career Management (ICM) Receives: Behavioral: Individual Career Management (ICM); Behavioral: Standard Care |
| Control | Active comparator | Standard Care (IAPT Therapy) Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (15)
Working Hours
Average number of hours worked each week
Measured: 6 months
Time to Employment
Number of days between baseline date and the employment start date.
Measured: 6 months
Salary
Average weekly salary over the 6 month period
Measured: 6 months
Number of Jobs
Number of different jobs held during the 6 month period
Measured: 6 months
Job Terminations
Number of job terminations over the 6 month period and the reason for each termination
Measured: 6 months
Other occupational activity
Non-competitive employment (e.g. sheltered work), education, training or volunteering
Measured: 6 months
Anxiety
Generalised Anxiety Disorder Assessment (GAD 7) score
Measured: 6 months
Depression
Patient Health Questionnaire (PHQ-9) score
Measured: 6 months
Social Functioning
Work and Social Adjustment Scale (WSAS)
Measured: 6 months
Health-related quality of Life
EQ-5D score
Measured: 6 months
Work-related quality of Life
WRQoL score
Measured: 6 months
Self Esteem
Rosenberg Self Esteem Scale
Measured: 6 months
Career Search Efficacy
Career Search Efficacy Scale (CSES) score
Measured: 6 months
Return to Work Efficacy
Return to Work Self Efficacy Scale (RTW-SE) score
Measured: 6 months
Productivity
Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Price, South London and Maudsley NHS Foundation Trust
- Investigators
- Claire Price, CPsychol, Principal investigator, South London and Maudsley NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599481
- Sponsor's protocol ID
- SLAM-ICM-1011
- Acronym
- CAREER
- Status last verified
- Aug 2015
- First submitted
- 14 May 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01599481
- Acronym / sponsor ID
- CAREER / SLAM-ICM-1011
- Conditions
- Anxiety, Depression
- Keywords
- Common mental illness, Supported Employment, Anxiety, Depression, Sickness absence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Individual Career Management (ICM), Behavioral: Standard CareStandard Care (IAPT Therapy) + Individual Career Management (ICM) |
| Control | Active comparator | Behavioral: Standard CareStandard Care (IAPT Therapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Career Management (ICM)Also: IPS, Supported EmploymentThe 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. | Behavioural | Intervention |
| Standard CareAlso: IAPT, CBTA package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner. | Behavioural | Control, Intervention |
Primary outcome
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.
15 secondary outcomes
Working Hours
Time frame: 6 months
Time to Employment
Time frame: 6 months
Salary
Time frame: 6 months
Number of Jobs
Time frame: 6 months
Job Terminations
Time frame: 6 months
Other occupational activity
Time frame: 6 months
Anxiety
Time frame: 6 months
Depression
Time frame: 6 months
Social Functioning
Time frame: 6 months
Health-related quality of Life
Time frame: 6 months
Work-related quality of Life
Time frame: 6 months
Self Esteem
Time frame: 6 months
Career Search Efficacy
Time frame: 6 months
Return to Work Efficacy
Time frame: 6 months
Productivity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Price, CPsychol principal investigator
South London and Maudsley NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individual Career Management (ICM) in people with Anxiety and Depression, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Competitive Employment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.