Improving Work Outcome for People With Severe Mental Illness

NCT ID: NCT01722344

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

717 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Individual Placement and Support (IPS)

Group Type EXPERIMENTAL

Individual Placement and support (IPS)

Intervention Type BEHAVIORAL

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

IPS plus

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

Group Type EXPERIMENTAL

Individual Placement and support (IPS)

Intervention Type BEHAVIORAL

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

IPS plus

Intervention Type BEHAVIORAL

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.

Standard intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Copenhagen Municipality, Denmark

OTHER_GOV

Sponsor Role collaborator

Odense Municipality

UNKNOWN

Sponsor Role collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Silkeborg Municipality

UNKNOWN

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lene F Eplov, MD, Phd

Role: STUDY_DIRECTOR

Copenhagen University Hospital, Mental Health Centre Copenhagen

Merete Nordentoft, Professor

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Mental Health Centre Copenhagen

Elsebeth Stenager, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Odense, The University of Southern Denmark.

Bent Nielsen, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Odense, The University of Southern Denmark

Locations

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Mental Health Centre Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31483451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26093636 (View on PubMed)

Other Identifiers

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PCK-2012-CT-2912

Identifier Type: -

Identifier Source: org_study_id

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