Clinical Trial: Improving Work Outcome for People With Severe Mental Illness

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Mental Health Centre Copenhagen

Current Primary Outcome: Hours in competitive employment or education [ Time Frame: Measured at 18 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Mental Health Centre Copenhagen

Dates:
Date Received: November 2, 2012
Date Started: October 2012
Date Completion: May 2018
Last Updated: April 10, 2017
Last Verified: April 2017