Improving Work Outcome for People With Severe Mental Illness

Not Applicable

Completed

• Conditions: Recurrent Depressive Disorder; Schizophrenia, Schizotypal and Delusional Disorders; Bipolar Affective Disorder
• Interventions: Behavioral: Individual Placement and support (IPS); Behavioral: IPS plus

• Registration Number: NCT01722344
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Primary Completion: 2017-08
• Study Completion: 2019-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 717

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPS plus	Individual Placement and support (IPS)	Individual Placement and Support plus cognitive remediation and work-related social skills training
IPS plus	IPS plus	Individual Placement and Support plus cognitive remediation and work-related social skills training
Individual Placement and Support (IPS)	Individual Placement and support (IPS)	-

Primary Outcome Measures

Name	Time	Method
Hours in competitive employment or education	Measured at 18 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mental Health Centre Copenhagen; 🇩🇰 Copenhagen, Denmark