Condition category
Mental and Behavioural Disorders
Date applied
03/04/2015
Date assigned
17/04/2015
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with severe mental illness have great difficulties in finding and keeping a job. IPS Supported Employment is a model provided by community mental health services to help those people get a job. However, despite this help, many participants still find it difficult to remain in employment.
Wellness Recovery Action Plan (WRAP) is a method which help people with severe mental illness to get more self-insight, build self-management competencies and strengthen their psychological recovery.
The aim of this study is to find out if combining IPS Supported Employment and WRAP increases chances of finding and keeping a job.

Who can participate?
Adults with severe mental illness using the services of four mental health agencies.

What does the study involve?
Participants are randomly allocated to one of two groups: IPS Supported Employment plus WRAP or IPS Supported Employment only. The work situation is assessed and participants fill in questionnaires at the start of the study, after six and 12 months.
Interviews of employment specialists as well to discuss benefits of WRAP.

What are the possible benefits and risks of participating?
There are no risks involved. All participants free to join or not to join.

Where is the study run from?
Led by the Trimbos Institute and conducted in partnership with the knowledge centre Phrenos. Four mental health agencies involved (Netherlands).

When is the study starting and how long is it expected to run for?
January 2013 to March 2015

Who is funding the study?
“ZonMw” programme ‘Participation and health’ ((Netherlands)

Who is the main contact?
Dr Harry Michon
hmichon@trimbos.nl

Trial website

Contact information

Type

Public

Primary contact

Dr. Harry Michon

ORCID ID

http://orcid.org/0000-0003-1373-0582

Contact details

PO Box 725
Utrecht
3500AS
Netherlands
+31653436275
hmichon@trimbos.nl

Type

Scientific

Additional contact

DR. Harry Michon

ORCID ID

http://orcid.org/0000-0003-1373-0582

Contact details

PO Box
Utrecht
3500AS
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

208030009-ZonMw

Study information

Scientific title

Enhancement of sustainable work in people with severe mental illness through Wellness Recovery Action Planning (WRAP) added to IPS Supported Employment: an explorative effectiveness study.

Acronym

WRAP

Study hypothesis

WRAP added to supported employment increases employability in people with severe mental illness.

Ethics approval

UMC Utrecht METC (Medical Research Ethics Committee), 09/10/2012, protocol number 12-490/C

Study design

Multi-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Severe mental illness

Intervention

Control or comparison condition is: Care as usual for people with severe mental illness who are client of case management teams of mental health services combined with IPS supported employment.
Experimental condition: WRAP = Wellness Recovery Action Plan added to care as usual for people with severe mental illness who are client of case management teams of mental health services combined with IPS Supported Employment.

Intervention type

Phase

Drug names

Primary outcome measures

1. Paid employment yes or no measured by monitoring though IPS employment specialists
2. Degree of self-reported Job satisfaction measured by the Indiana Job Satisfaction; Questionnaire (2 sub scales: a. overall job satisfaction, and b. perceived job match)
3. Self-reported well-being in emotional role functioning measured by RAND-36 (sub scale)

Measured at the start of the study, after six and 12 months.

Secondary outcome measures

1. Self-reported self-efficacy measured by the Mental Health Self Confidence scale
2. Self-reported empowerment measured by the Dutch Empowerment scale (2 sub scales: a. own wisdom and b. self-management)

Measured at the start of the study, after six and 12 months.

Overall trial start date

01/12/2010

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Being employed at randomisation phase
2. 18 years old or older
3. Agreeing to participate in the study
4. Informed consent

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

64 (80 initially - 64 was agreed with the funder after a change in the design (recruitment in 4 instead of 10 sites) because of a policy change in the Netherlands

Participant exclusion criteria

Having participated in WRAP in the year before trial start

Recruitment start date

18/01/2013

Recruitment end date

04/01/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

GGzE
Eindhoven
Netherlands

Trial participating centre

GGZ Noord-Holland-Noord
Alkmaar
Netherlands

Trial participating centre

AMC-VIP team
Amsterdam
Netherlands

Trial participating centre

Lentis
Groningen
Netherlands

Sponsor information

Organisation

Trimbos Institute

Sponsor details

Po Box 725
Utrecht
3500 AS
Netherlands
+31302971100
info@trimbos.nl

Sponsor type

Research organisation

Website

www.trimbos.nl

Funders

Funder type

Government

Funder name

The Netherlands Organisation for Health Research and Development ("ZonMw")

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Reports expected by July 2015.

Intention to publish date

31/07/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes