Improving Work Outcome for People With Severe Mental Illness

ID: NCT01722344
Status: Active, not recruiting
Phase: N/A
Start Date: October 01, 2012
First Submitted: November 02, 2012
Last Updated: December 05, 2017
Results: N/A
Sponsors & Collaborators: Mental Health Centre Copenhagen, Odense University Hospital, Copenhagen Municipality, Odense Municipality, Copenhagen Trial Unit and 2 more..
Location: Denmark
Conditions: Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder
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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.
Condition or disease Intervention/treatment Phase

Bipolar Affective Disorder

Recurrent Depressive Disorder

Schizophrenia, Schizotypal and Delusional Disorders

Behavioral: Individual Placement and support (IPS)
Other Names
Behavioral: IPS plus
Other Names
N/A

Tracking Information

First Submitted DateNovember 02, 2012
Last Update Posted DateDecember 05, 2017
Start DateOctober 01, 2012
Anticipated Completion DateMay 01, 2018
Primary Completion DateAugust 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Hours in competitive employment or education [Time Frame: Measured at 18 month]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • In competitive employment or education at some point during follow up period [Time Frame: Measured at 18 month follow-up]

  • Days to first employment or beginning of education [Time Frame: Measured at 18 month follow-up]

  • Average monthly earnings in follow-up period [Time Frame: 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]

  • Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS) [Time Frame: 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]

  • Functioning measured with Global Assessment of Functioning (GAF) [Time Frame: Measured at 18 month follow-up]

  • Functioning measured with Personal and Social Performance (PSP) [Time Frame: Measured at 18 month follow-up]

  • Quality of life measured with SF-12 [Time Frame: Measured at 18 month follow-up]

  • Empowerment measured with Empowerment Scale [Time Frame: Measured at 18 month follow-up]

  • Self-efficacy measured with General self-efficacy scale (GSE) [Time Frame: Measured at 18 month follow-up]

  • Self-esteem measured with The Rosenberg Self-Esteem scale [Time Frame: Measured at 18 month follow-up]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleImproving Work Outcome for People With Severe Mental Illness
Official TitleIndividual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
717
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Other
Conditions
Bipolar Affective Disorder
Recurrent Depressive Disorder
Schizophrenia, Schizotypal and Delusional Disorders
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: 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

Other Names
Behavioral: IPS plus

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.

Other Names
Study Groups/Cohorts
Individual Placement and Support (IPS)

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

Standard intervention

Study Arms
Experimental Individual Placement and Support (IPS)
Behavioral : 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
Behavioral : 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
Behavioral : IPS plus
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.

Arm Intervention/Treatment
Experimental Individual Placement and Support (IPS)
Behavioral : Individual Placement and support (IPS)
Experimental IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
Behavioral : Individual Placement and support (IPS)
Experimental IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
Behavioral : IPS plus

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment717
Completion DateMay 01, 2018
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)
GenderAll
Age18 Years to 64 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Denmark

Administrative Information

NCT Number:NCT01722344
Other Study ID Numbers
PCK-2012-CT-2912
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Mental Health Centre Copenhagen
Collaborators
Odense University Hospital
Copenhagen Municipality
Odense Municipality
Copenhagen Trial Unit, Center for Clinical Intervention Research
Silkeborg Municipality
Investigators
Principal Investigator
Bent Nielsen, Professor
Department of Psychiatry, Odense, The University of Southern Denmark
Principal Investigator
Elsebeth Stenager, MD, Phd
Department of Psychiatry, Odense, The University of Southern Denmark.
Principal Investigator
Merete Nordentoft, Professor
Copenhagen University Hospital, Mental Health Centre Copenhagen
Study Director
Lene F Eplov, MD, Phd
Copenhagen University Hospital, Mental Health Centre Copenhagen