Working with WRAP

ISRCTN	ISRCTN97969491
DOI	https://doi.org/10.1186/ISRCTN97969491
Secondary identifying numbers	208030009-ZonMw

Submission date: 03/04/2015
Registration date: 17/04/2015
Last edited: 17/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr. Harry Michon
Public

PO Box 725
Utrecht
3500AS
Netherlands

ORCID ID	0000-0003-1373-0582
Phone	+31653436275
Email	hmichon@trimbos.nl

DR. Harry Michon
Scientific

PO Box
Utrecht
3500AS
Netherlands

ORCID ID	0000-0003-1373-0582

Study information

Study design	Multi-centre interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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.
Study acronym	WRAP
Study objectives	WRAP added to supported employment increases employability in people with severe mental illness.
Ethics approval(s)	UMC Utrecht METC (Medical Research Ethics Committee), 09/10/2012, protocol number 12-490/C
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2010
Completion date	01/06/2015

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	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
Key inclusion criteria	1. Being employed at randomisation phase 2. 18 years old or older 3. Agreeing to participate in the study 4. Informed consent
Key exclusion criteria	Having participated in WRAP in the year before trial start
Date of first enrolment	18/01/2013
Date of final enrolment	04/01/2014

Locations

Countries of recruitment

Netherlands

Study participating centres

GGzE

Eindhoven
Netherlands

GGZ Noord-Holland-Noord

Alkmaar
Netherlands

AMC-VIP team

Amsterdam
Netherlands

Lentis

Groningen
Netherlands

Sponsor information

Trimbos Institute
Research organisation

Po Box 725
Utrecht
3500 AS
Netherlands

Phone	+31302971100
Email	info@trimbos.nl
Website	www.trimbos.nl
"ROR"	https://ror.org/02amggm23

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date	31/07/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Reports expected by July 2015.
IPD sharing plan