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Improving Work Outcome for People With Severe Mental Illness

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01722344
Enrollment
717
Registered
2012-11-06
Start date
2012-10-31
Completion date
2019-02-28
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Affective Disorder, Recurrent Depressive Disorder, Schizophrenia, Schizotypal and Delusional Disorders

Keywords

Severe mental illness, Vocational rehabilitation, Supported employment, Individual placement and support, Cognitive remediation, Social skill training

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.

Interventions

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

BEHAVIORALIPS 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.

Sponsors

Odense University Hospital
CollaboratorOTHER
Copenhagen Municipality, Denmark
CollaboratorOTHER_GOV
Odense Municipality
CollaboratorUNKNOWN
Copenhagen Trial Unit, Center for Clinical Intervention Research
CollaboratorOTHER
Silkeborg Municipality
CollaboratorUNKNOWN
Mental Health Services in the Capital Region, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Hours in competitive employment or educationMeasured at 18 month

Secondary

MeasureTime frame
Days to first employment or beginning of educationMeasured at 18 month follow-up
Average monthly earnings in follow-up periodMeasured at 18 month follow-up
Hours of work per week among those who obtain competitive employment during the follow-up periodMeasured 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
In competitive employment or education at some point during follow up periodMeasured 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-12Measured at 18 month follow-up
Empowerment measured with Empowerment ScaleMeasured at 18 month follow-up
Self-efficacy measured with General self-efficacy scale (GSE)Measured at 18 month follow-up
Self-esteem measured with The Rosenberg Self-Esteem scaleMeasured at 18 month follow-up
Functioning measured with Global Assessment of Functioning (GAF)Measured at 18 month follow-up

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026