NCT01599481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for phase_2 anxiety

Timeline
Completed

Started Oct 2011

Typical duration for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

May 14, 2012

Last Update Submit

August 19, 2015

Conditions

AnxietyDepression

Keywords

Common mental illnessSupported EmploymentAnxietyDepressionSickness absence

Outcome Measures

Primary Outcomes (1)

  • Length of Competitive Employment

    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.

    6 months

Secondary Outcomes (15)

  • Working Hours

    6 months

  • Time to Employment

    6 months

  • Salary

    6 months

  • Number of Jobs

    6 months

  • Job Terminations

    6 months

  • +10 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Standard Care (IAPT Therapy) + Individual Career Management (ICM)

Behavioral: Individual Career Management (ICM)Behavioral: Standard Care

Control

ACTIVE COMPARATOR

Standard Care (IAPT Therapy)

Behavioral: Standard Care

Interventions

Individual Career Management (ICM)BEHAVIORAL

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.

Also known as: IPS, Supported Employment
Intervention
Standard CareBEHAVIORAL

A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.

Also known as: IAPT, CBT
ControlIntervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwark Psychological Therapies Service

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Employment, SupportedStandard of Care

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

EmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Claire Price, CPsychol

    South London and Maudsley NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Employment & Social Inclusion Manager

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

GB(1)