Improving Work Outcome for People With Severe Mental Illness
Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
1 other identifier
interventional
717
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
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, 2012
CompletedFirst Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMarch 15, 2024
March 1, 2024
4.8 years
November 2, 2012
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hours in competitive employment or education
Measured at 18 month
Secondary Outcomes (12)
In competitive employment or education at some point during follow up period
Measured at 18 month follow-up
Days to first employment or beginning of education
Measured at 18 month follow-up
Average monthly earnings in follow-up period
Measured at 18 month follow-up
Hours of work per week among those who obtain competitive employment during the follow-up period
Measured at 18 month follow-up
Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
Measured at 18 month follow-up
- +7 more secondary outcomes
Study Arms (3)
Individual Placement and Support (IPS)
EXPERIMENTALIPS plus
EXPERIMENTALIndividual Placement and Support plus cognitive remediation and work-related social skills training
Standard intervention
NO INTERVENTIONInterventions
IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling
Individual Placement and Support + cognitive remediation and work-related social skills training, consists of the IPS intervention + 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
Eligibility Criteria
You may qualify if:
- Psychosis within the schizophrenic spectrum (F 2, International Classification of Diseases (ICD 10)).
- Severe depression (F33, ICD-10) or Bipolar disorder (F31, ICD-10) and minimum 3 years psychiatric treatment.
- Motivated for employment or education. 18 to 65 years old. Participants must speak and understand Danish.
You may not qualify if:
- Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospitallead
- Odense University Hospitalcollaborator
- Copenhagen Municipality, Denmarkcollaborator
- Odense Municipalitycollaborator
- Copenhagen Trial Unit, Center for Clinical Intervention Researchcollaborator
- Silkeborg Municipalitycollaborator
Study Sites (1)
Mental Health Centre Copenhagen
Copenhagen, 2400, Denmark
Related Publications (2)
Christensen TN, Wallstrom IG, Stenager E, Bojesen AB, Gluud C, Nordentoft M, Eplov LF. Effects of Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training for People With Severe Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Dec 1;76(12):1232-1240. doi: 10.1001/jamapsychiatry.2019.2291.
PMID: 31483451DERIVEDChristensen TN, Nielsen IG, Stenager E, Morthorst BR, Lindschou J, Nordentoft M, Eplov LF. Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:280. doi: 10.1186/s13063-015-0792-0.
PMID: 26093636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lene F Eplov, MD, Phd
Copenhagen University Hospital, Mental Health Centre Copenhagen
- PRINCIPAL INVESTIGATOR
Merete Nordentoft, Professor
Copenhagen University Hospital, Mental Health Centre Copenhagen
- PRINCIPAL INVESTIGATOR
Elsebeth Stenager, MD, Phd
Department of Psychiatry, Odense, The University of Southern Denmark.
- PRINCIPAL INVESTIGATOR
Bent Nielsen, Professor
Department of Psychiatry, Odense, The University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 6, 2012
Study Start
October 1, 2012
Primary Completion
August 1, 2017
Study Completion
February 1, 2019
Last Updated
March 15, 2024
Record last verified: 2024-03