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

Depression Clinical Trial

— CAREER  

Official title:

Effectiveness and Cost Effectiveness of Individual Career Management for People With Anxiety and Depression: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599481
• Other study ID #: SLAM-ICM-1011
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2012
• Last updated: August 19, 2015
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: South London and Maudsley NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.
• Standard Care
A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.

Locations

Country	Name	City	State
United Kingdom	Southwark Psychological Therapies Service	London

Sponsors (1)

Lead Sponsor	Collaborator
South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	Working Hours	Average number of hours worked each week	6 months	No
Secondary	Time to Employment	Number of days between baseline date and the employment start date.	6 months	No
Secondary	Salary	Average weekly salary over the 6 month period	6 months	No
Secondary	Number of Jobs	Number of different jobs held during the 6 month period	6 months	No
Secondary	Job Terminations	Number of job terminations over the 6 month period and the reason for each termination	6 months	No
Secondary	Other occupational activity	Non-competitive employment (e.g. sheltered work), education, training or volunteering	6 months	No
Secondary	Anxiety	Generalised Anxiety Disorder Assessment (GAD 7) score	6 months	No
Secondary	Depression	Patient Health Questionnaire (PHQ-9) score	6 months	No
Secondary	Social Functioning	Work and Social Adjustment Scale (WSAS)	6 months	No
Secondary	Health-related quality of Life	EQ-5D score	6 months	No
Secondary	Work-related quality of Life	WRQoL score	6 months	No
Secondary	Self Esteem	Rosenberg Self Esteem Scale	6 months	No
Secondary	Career Search Efficacy	Career Search Efficacy Scale (CSES) score	6 months	No
Secondary	Return to Work Efficacy	Return to Work Self Efficacy Scale (RTW-SE) score	6 months	No
Secondary	Productivity	Absenteeism and presenteeism questions from the World Health Organization's Health and Work Performance Questionnaire (HPQ)	6 months	No