Improving Work Outcome for People With Severe Mental Illness

Bipolar Affective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722344
• Other study ID #: PCK-2012-CT-2912
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: February 2019

Study information

• Verified date: March 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: February 2019
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Depressive Disorder
• Mood Disorders
• Recurrent Depressive Disorder
• Schizophrenia
• Schizophrenia, Paranoid
• Schizophrenia, Schizotypal and Delusional Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Copenhagen Municipality, Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Odense Municipality, Odense University Hospital, Silkeborg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours in competitive employment or education		Measured at 18 month
Secondary	In competitive employment or education at some point during follow up period		Measured at 18 month follow-up
Secondary	Days to first employment or beginning of education		Measured at 18 month follow-up
Secondary	Average monthly earnings in follow-up period		Measured at 18 month follow-up
Secondary	Hours of work per week among those who obtain competitive employment during the follow-up period		Measured at 18 month follow-up
Secondary	Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)		Measured at 18 month follow-up
Secondary	Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)		Measured at 18 month follow-up
Secondary	Functioning measured with Global Assessment of Functioning (GAF)		Measured at 18 month follow-up
Secondary	Functioning measured with Personal and Social Performance (PSP)		Measured at 18 month follow-up
Secondary	Quality of life measured with SF-12		Measured at 18 month follow-up
Secondary	Empowerment measured with Empowerment Scale		Measured at 18 month follow-up
Secondary	Self-efficacy measured with General self-efficacy scale (GSE)		Measured at 18 month follow-up
Secondary	Self-esteem measured with The Rosenberg Self-Esteem scale		Measured at 18 month follow-up