NCT00960024

Brief Summary

This project aims at generating evidence of a work-rehabilitation strategy that benefits the people with severe mental illness (SMI) who want to work, increase their sense of well-being and integration in society, decrease their financial dependence and experiences of stigma and discrimination. The project is likely to help form the basis of how to implement the evidence based supported employment (SE)-model, Individual Placement and Support model (IPS), in a Swedish work-rehabilitation context. In the long run, evidence of SE in a Swedish context could help to decrease the period of sick-leave and increase fulfilling and productive lifestyles among people with severe mental illness. In all, the effectiveness of SE can improve the quality of life for the target group, the quality in mental health care rehabilitation and decrease the costs of treatment and care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

August 14, 2009

Last Update Submit

August 14, 2009

Conditions

Psychosis

Keywords

Vocational rehabilitationSevere mental illnessPsychosisMental Health

Outcome Measures

Primary Outcomes (1)

  • To determine the effectiveness of SE/IPS in terms of vocational outcomes, such as employment rate, monthly income, job-tenure and working hours compared to stepwise rehabilitation available, for people with SMI in a Swedish context

    6 months, 18 months, and 24 months (6 months after end of intervention)

Secondary Outcomes (1)

  • To determine the effectiveness of a SE in terms health-related and functional outcomes, such as symptoms, perceived discrimination, empowerment, work-readiness, self-image, level of social and community participation, and quality of life

    6 months, 18 months, and 24 months (6 months after end of intervention)

Study Arms (2)

Individual Placement and Support-vocational rehabilitation

EXPERIMENTAL
Behavioral: Individual Placement and Support-vocational rehabilitation

Vocational rehabilitation available at study site

ACTIVE COMPARATOR
Behavioral: Vocational rehabilitation available

Interventions

Individual Placement and Support-vocational rehabilitationBEHAVIORAL

Individual contact with an employment specialist, who works according to 7 core principles according to SE/IPS. 1) competitive employment as primary goal, 2) rapid job search, 3) eligibility based on client choice, 4) job search based on to client preferences, 5) integration with the mental health care team, 6) availability of time unlimited support at work 7) benefits counseling.

Individual Placement and Support-vocational rehabilitation
Vocational rehabilitation availableBEHAVIORAL

The participants are offered vocational rehabilitation available at site

Vocational rehabilitation available at study site

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with Severe mental illness, which mostly means having a diagnosis of psychosis
  • Communicate in Swedish
  • Express interest in working in the near future
  • Have professional care or support from psychiatric clinic
  • Attend to a SE-introductory meeting

You may not qualify if:

  • Additional organic or physical disability to having psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Vardal Institute, Medical Faculty, Lund University

Lund, 221 00, Sweden

Location

Related Publications (2)

  • Bejerholm U, Areberg C, Hofgren C, Sandlund M, Rinaldi M. Individual placement and support in Sweden - a randomized controlled trial. Nord J Psychiatry. 2015 Jan;69(1):57-66. doi: 10.3109/08039488.2014.929739. Epub 2014 Jul 1.

    PMID: 24983382DERIVED

  • Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health and social care. Implement Sci. 2010 Sep 3;5:67. doi: 10.1186/1748-5908-5-67.

    PMID: 20815872DERIVED

MeSH Terms

Conditions

Psychotic DisordersMental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersPersonal SatisfactionBehavior

Study Officials

  • Staffan Johansson, Assoc Prof

    Vardalinstitutet The Swedish Institute for Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

April 1, 2008

Primary Completion

February 1, 2011

Study Completion

December 1, 2015

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations

SE(1)