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Trial record 1 of 1 for:    NCT01722344
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Improving Work Outcome for People With Severe Mental Illness

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ClinicalTrials.gov Identifier: NCT01722344
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
Odense University Hospital
Copenhagen Municipality, Denmark
Odense Municipality
Copenhagen Trial Unit, Center for Clinical Intervention Research
Silkeborg Municipality
Information provided by (Responsible Party):
Mental Health Centre Copenhagen

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.

Condition or disease Intervention/treatment Phase
Schizophrenia, Schizotypal and Delusional Disorders Bipolar Affective Disorder Recurrent Depressive Disorder Behavioral: Individual Placement and support (IPS) Behavioral: IPS plus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 717 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Actual Study Start Date : October 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.

No Intervention: Standard intervention



Primary Outcome Measures :
  1. Hours in competitive employment or education [ Time Frame: Measured at 18 month ]

Secondary Outcome Measures :
  1. In competitive employment or education at some point during follow up period [ Time Frame: Measured at 18 month follow-up ]
  2. Days to first employment or beginning of education [ Time Frame: Measured at 18 month follow-up ]
  3. Average monthly earnings in follow-up period [ Time Frame: Measured at 18 month follow-up ]
  4. Hours of work per week among those who obtain competitive employment during the follow-up period [ Time Frame: Measured at 18 month follow-up ]
  5. Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS) [ Time Frame: Measured at 18 month follow-up ]
  6. Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC) [ Time Frame: Measured at 18 month follow-up ]
  7. Functioning measured with Global Assessment of Functioning (GAF) [ Time Frame: Measured at 18 month follow-up ]
  8. Functioning measured with Personal and Social Performance (PSP) [ Time Frame: Measured at 18 month follow-up ]
  9. Quality of life measured with SF-12 [ Time Frame: Measured at 18 month follow-up ]
  10. Empowerment measured with Empowerment Scale [ Time Frame: Measured at 18 month follow-up ]
  11. Self-efficacy measured with General self-efficacy scale (GSE) [ Time Frame: Measured at 18 month follow-up ]
  12. Self-esteem measured with The Rosenberg Self-Esteem scale [ Time Frame: Measured at 18 month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722344


Locations
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Denmark
Mental Health Centre Copenhagen
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Mental Health Centre Copenhagen
Odense University Hospital
Copenhagen Municipality, Denmark
Odense Municipality
Copenhagen Trial Unit, Center for Clinical Intervention Research
Silkeborg Municipality
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT01722344    
Other Study ID Numbers: PCK-2012-CT-2912
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Keywords provided by Mental Health Centre Copenhagen:
Severe mental illness
Vocational rehabilitation
Supported employment
Individual placement and support
Cognitive remediation
Social skill training
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Mood Disorders
Bipolar Disorder
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders