Clinical trial NCT01599481: Career Management to Improve Education, Employment and Retention for People With Anxiety and Depression
Official title: Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Depression
Keywords: Common mental illness
Supported Employment
Anxiety
Depression
Sickness absence
Lead sponsor: South London and Maudsley NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Length of Competitive Employment
timeFrame: 6 months
Secondary outcomes:
measure: Working Hours
timeFrame: 6 months
measure: Time to Employment
timeFrame: 6 months
measure: Salary
timeFrame: 6 months
measure: Number of Jobs
timeFrame: 6 months
measure: Job Terminations
timeFrame: 6 months
measure: Other occupational activity
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Social Functioning
timeFrame: 6 months
measure: Health-related quality of Life
timeFrame: 6 months
measure: Work-related quality of Life
timeFrame: 6 months
measure: Self Esteem
timeFrame: 6 months
measure: Career Search Efficacy
timeFrame: 6 months
measure: Return to Work Efficacy
timeFrame: 6 months
measure: Productivity
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Southwark Psychological Therapies Service
Study officials:
affiliation: South London and Maudsley NHS Foundation Trust
name: Claire Price, CPsychol
role: PRINCIPAL_INVESTIGATOR
References: