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Completed

NCT Number: NCT01722344

Improving Work Outcome for People With Severe Mental Illness

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.

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Key information

Conditions

Schizophrenia, Schizotypal and Delusional Disorders Bipolar Affective Disorder Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Mental Disorders Mood Disorders Recurrent Depressive Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Centre Copenhagen

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Individual Placement and Support (IPS)

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

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.

Primary outcomes

  1. Hours in competitive employment or education

    Time frame: Measured at 18 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Copenhagen Municipality, Denmark
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Odense Municipality
  • Odense University Hospital
  • Silkeborg Municipality

Registry information

Official study title

Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Nov 6, 2012
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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