Condition category
Mental and Behavioural Disorders
Date applied
05/06/2014
Date assigned
02/07/2014
Last edited
02/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Germany, the number of days of absence from work caused by mental illness has risen dramatically in the past ten years. Due to lack of qualified staff, it is very important for companies to take care of the physical and mental health of their workers. As a result, the number of people who are unable to work due to mental stress and diseases is extremely high. Supported Employment concepts such as the Individual Placement and Support (IPS) model look at making work a rehabilitative agent itself. Supported Employment Plus (SEplus) uses a modified IPS-approach in order to: maintain the affected employee’s work ability and performance, re-establish the employee’s mental well-being in the workplace, preserve the work capacity and productivity for the company; reduce the number of days of absence due to mental health problems.

Who can participate?
Employees of the participating businesses who report psychological distress can take part.

What does the study involve?
Employees are randomly allocated to one of two groups: intervention and control groups. The intervention group receives SEplus the affected workers are specifically and individually coached by experienced job coaches. These job coaches also fulfil an advisory and supportive role for the employer, the colleagues and other stakeholders of the business environment.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
The study is run from participating business enterprise and service companies in Germany.

When is the study starting and how long is it expected to run for?
October 2012 to September 2014.

Who is funding the study?
European Regional Development Fund (ERDF) (EU)

Who is the main contact?
Prof Wulf Rössler
wulf.roessler@uzh.ch

Trial website

http://www.leuphana.de/partner/regional/gesundheit/vernetzte-versorgung/projekte/supported-employment-plus.html

Contact information

Type

Scientific

Primary contact

Prof Wulf Rössler

ORCID ID

Contact details

University of Lüneburg
Innovation Incubator
Rotenbleicher Weg 67
Lüneburg
21335
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Job maintenance through Supported Employment PLUS

Acronym

SEplus

Study hypothesis

1. Job Coaching according to the approach of Individual Placement and Support (IPS) can contribute to job maintenance of employees under psychological pressure or with mental illnesses. Furthermore, coaching according to IPS enhances job satisfaction and reduces the number of days of sickness absence.
2. In addition we hypothesize the following:
2.1. Improvement of job satisfaction in the intervention group.
2.2. Improvement of global functioning in the intervention group.
2.3. Improvement of the quality of life of the participants of the intervention group.
2.4. Increased self-esteem of the participants of the intervention group.
2.5. Reduction of self-stigma in the intervention group.
2.6. Reduction of cognitive appraisal of stigma as a stressor in the intervention group.
2.7. Enhancement of recovery orientation in the intervention group.

Ethics approval

Ethics Committee of the Leuphana University of Lüneburg, 25.09.2013, ref. EB-Antrag Rössler201307_SEplus

Study design

Randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental disorders, vocational rehabilitation

Intervention

The intervention lasts from three to six months. The participants should attend to eight to twelve coaching sessions. The job coaches support the participants of the intervention group concerning problems on the job and other psychosocial problems. 50% of the participants are randomized to the intervention group and 50% to the control group.

Several instrument based interviews are conducted every 3 months.

A two-factor analysis of variance with the two factors “group affiliation” (Intervention- and control group) and outcome (reduction days of illness yes/no) will be conducted to control for the study hypotheses.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary endpoint is the reduction of days incapacity to work by 40% compared with the control group.

Secondary outcome measures

1. Quality of life
2. Motivation
3. Job satisfaction
4. Psychosocial functioning
5. Job preferences
6. Self-esteem

Overall trial start date

01/10/2012

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Employee of a cooperation partner (e.g. business enterprise or service company) of the study
2. Self-reporting of psychological stress or mental disorder
3. Psychic distress or mental disorder
4. Voluntariness
5. Participant have to give informed consent
6. Working age (18-67 years)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Persons who need a psychiatric inpatient treatment at the time of the study
2. Persons with an imminent risk of suicide

Recruitment start date

01/10/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University of Lüneburg
Lüneburg
21335
Germany

Sponsor information

Organisation

European Regional Development Fund (ERDF), Investitions- und Förderbank Niedersachsen - NBank (Germany)

Sponsor details

Günther-Wagner-Allee 12 - 16
Hannover
30177
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

European Regional Development Fund (ERDF) (EU)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes