- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722344
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individual Placement and Support (IPS) is established as the most effective vocational intervention available for persons with severe mental illness,and the intervention is widely recognized as an evidence-based practice. Despite evidence, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Research has suggested that integrating methods such as cognitive remediation and social skills training could reduce such limitations. Further, there has not been conducted any randomized controled trials with IPS in Scandinavian countries with highly developed and generous social security and welfare systems, and with high thresholds to the open labour market.
The aim of this study is to investigate the effectiveness of IPS in Denmark and compare effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. Standard intervention.
The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced with cognitive remediation and work-related social skills training, consists of 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2400
- Mental Health Centre Copenhagen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individual Placement and Support (IPS)
|
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
|
Experimental: IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
|
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.
|
No Intervention: Standard intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hours in competitive employment or education
Time Frame: Measured at 18 month
|
Measured at 18 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In competitive employment or education at some point during follow up period
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Days to first employment or beginning of education
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Average monthly earnings in follow-up period
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Hours of work per week among those who obtain competitive employment during the follow-up period
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Functioning measured with Global Assessment of Functioning (GAF)
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Functioning measured with Personal and Social Performance (PSP)
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Quality of life measured with SF-12
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Empowerment measured with Empowerment Scale
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Self-efficacy measured with General self-efficacy scale (GSE)
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Self-esteem measured with The Rosenberg Self-Esteem scale
Time Frame: Measured at 18 month follow-up
|
Measured at 18 month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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. Erratum In: JAMA Psychiatry. 2019 Oct 16;:
- Christensen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCK-2012-CT-2912
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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