Overview

This trial is active, not recruiting.

Conditions schizophrenia, schizotypal and delusional disorders, bipolar affective disorder, recurrent depressive disorder
Treatments individual placement and support (ips), ips plus
Sponsor Mental Health Centre Copenhagen
Collaborator Odense University Hospital
Start date October 2012
End date July 2017
Trial size 717 participants
Trial identifier NCT01722344, PCK-2012-CT-2912

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
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)
Individual Placement and Support plus cognitive remediation and work-related social skills training
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
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)

Primary Outcomes

Measure
Hours in competitive employment or education
time frame: Measured at 18 month

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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)

Additional Information

Official title Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Principal investigator Merete Nordentoft, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Mental Health Centre Copenhagen.