Southwark Psychological Therapies Service
London, SE5 8AZ, United Kingdom
NCT Number: NCT01599481
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
London, SE5 8AZ, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: IPS, Supported Employment
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
Other names: IAPT, CBT
Time frame: 6 months
Length of competitive employment during the 6 month study period. The following definition of competitive employment will be used:
Time frame: 6 months
Average number of hours worked each week
Time frame: 6 months
Number of days between baseline date and the employment start date.
Time frame: 6 months
Average weekly salary over the 6 month period
Time frame: 6 months
Number of different jobs held during the 6 month period
Time frame: 6 months
Number of job terminations over the 6 month period and the reason for each termination
Time frame: 6 months
Non-competitive employment (e.g. sheltered work), education, training or volunteering
Time frame: 6 months
Generalised Anxiety Disorder Assessment (GAD 7) score
Time frame: 6 months
Patient Health Questionnaire (PHQ-9) score
Time frame: 6 months
Work and Social Adjustment Scale (WSAS)
Time frame: 6 months
EQ-5D score
Time frame: 6 months
WRQoL score
Time frame: 6 months
Rosenberg Self Esteem Scale
Time frame: 6 months
Career Search Efficacy Scale (CSES) score
Time frame: 6 months
Return to Work Self Efficacy Scale (RTW-SE) score
Time frame: 6 months
Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)
South London and Maudsley NHS Foundation Trust
Other
Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial
Acronym: CAREER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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