Improving Work Outcome for People With Severe Mental Illness

March 14, 2024 updated by: Mental Health Services in the Capital Region, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

717

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Mental Health Centre Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hours in competitive employment or education
Time Frame: Measured at 18 month
Measured at 18 month

Secondary Outcome Measures

Outcome Measure
Time Frame
In competitive employment or education at some point during follow up period
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Days to first employment or beginning of education
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Average monthly earnings in follow-up period
Time Frame: Measured at 18 month follow-up
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
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
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
Measured at 18 month follow-up
Functioning measured with Global Assessment of Functioning (GAF)
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Functioning measured with Personal and Social Performance (PSP)
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Quality of life measured with SF-12
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Empowerment measured with Empowerment Scale
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Self-efficacy measured with General self-efficacy scale (GSE)
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up
Self-esteem measured with The Rosenberg Self-Esteem scale
Time Frame: Measured at 18 month follow-up
Measured at 18 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

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

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimated)

November 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCK-2012-CT-2912

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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