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Improving Work Outcome for People With Severe Mental Illness

Primary Purpose

Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individual Placement and support (IPS)
IPS plus
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia, Schizotypal and Delusional Disorders focused on measuring Severe mental illness, Vocational rehabilitation, Supported employment, Individual placement and support, Cognitive remediation, Social skill training

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mental Health Centre Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Individual Placement and Support (IPS)

IPS plus

Standard intervention

Arm Description

Individual Placement and Support plus cognitive remediation and work-related social skills training

Outcomes

Primary Outcome Measures

Hours in competitive employment or education

Secondary Outcome Measures

In competitive employment or education at some point during follow up period
Days to first employment or beginning of education
Average monthly earnings in follow-up period
Hours of work per week among those who obtain competitive employment during the follow-up period
Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
Functioning measured with Global Assessment of Functioning (GAF)
Functioning measured with Personal and Social Performance (PSP)
Quality of life measured with SF-12
Empowerment measured with Empowerment Scale
Self-efficacy measured with General self-efficacy scale (GSE)
Self-esteem measured with The Rosenberg Self-Esteem scale

Full Information

First Posted
November 2, 2012
Last Updated
September 7, 2021
Sponsor
Mental Health Centre Copenhagen
Collaborators
Odense University Hospital, Copenhagen Municipality, Denmark, Odense Municipality, Copenhagen Trial Unit, Center for Clinical Intervention Research, Silkeborg Municipality
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1. Study Identification

Unique Protocol Identification Number
NCT01722344
Brief Title
Improving Work Outcome for People With Severe Mental Illness
Official Title
Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Centre Copenhagen
Collaborators
Odense University Hospital, Copenhagen Municipality, Denmark, Odense Municipality, Copenhagen Trial Unit, Center for Clinical Intervention Research, Silkeborg Municipality

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder
Keywords
Severe mental illness, Vocational rehabilitation, Supported employment, Individual placement and support, Cognitive remediation, Social skill training

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
717 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Placement and Support (IPS)
Arm Type
Experimental
Arm Title
IPS plus
Arm Type
Experimental
Arm Description
Individual Placement and Support plus cognitive remediation and work-related social skills training
Arm Title
Standard intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and support (IPS)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
IPS plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hours in competitive employment or education
Time Frame
Measured at 18 month
Secondary Outcome Measure Information:
Title
In competitive employment or education at some point during follow up period
Time Frame
Measured at 18 month follow-up
Title
Days to first employment or beginning of education
Time Frame
Measured at 18 month follow-up
Title
Average monthly earnings in follow-up period
Time Frame
Measured at 18 month follow-up
Title
Hours of work per week among those who obtain competitive employment during the follow-up period
Time Frame
Measured at 18 month follow-up
Title
Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
Time Frame
Measured at 18 month follow-up
Title
Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
Time Frame
Measured at 18 month follow-up
Title
Functioning measured with Global Assessment of Functioning (GAF)
Time Frame
Measured at 18 month follow-up
Title
Functioning measured with Personal and Social Performance (PSP)
Time Frame
Measured at 18 month follow-up
Title
Quality of life measured with SF-12
Time Frame
Measured at 18 month follow-up
Title
Empowerment measured with Empowerment Scale
Time Frame
Measured at 18 month follow-up
Title
Self-efficacy measured with General self-efficacy scale (GSE)
Time Frame
Measured at 18 month follow-up
Title
Self-esteem measured with The Rosenberg Self-Esteem scale
Time Frame
Measured at 18 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene F Eplov, MD, Phd
Organizational Affiliation
Copenhagen University Hospital, Mental Health Centre Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Merete Nordentoft, Professor
Organizational Affiliation
Copenhagen University Hospital, Mental Health Centre Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elsebeth Stenager, MD, Phd
Organizational Affiliation
Department of Psychiatry, Odense, The University of Southern Denmark.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bent Nielsen, Professor
Organizational Affiliation
Department of Psychiatry, Odense, The University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Centre Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31483451
Citation
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;:
Results Reference
derived
PubMed Identifier
26093636
Citation
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.
Results Reference
derived

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Improving Work Outcome for People With Severe Mental Illness

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