Clinical trial NCT01722344: Improving Work Outcome for People With Severe Mental Illness
Official title: Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia, Schizotypal and Delusional Disorders
Bipolar Affective Disorder
Recurrent Depressive Disorder
Keywords: Severe mental illness
Vocational rehabilitation
Supported employment
Individual placement and support
Cognitive remediation
Social skill training
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Copenhagen Municipality, Denmark
name: Odense Municipality
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Silkeborg Municipality
First posted: 2012-11-06
Enrollment: 717
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hours in competitive employment or education
timeFrame: Measured at 18 month
Secondary outcomes:
measure: In competitive employment or education at some point during follow up period
timeFrame: Measured at 18 month follow-up
measure: Days to first employment or beginning of education
timeFrame: Measured at 18 month follow-up
measure: Average monthly earnings in follow-up period
timeFrame: Measured at 18 month follow-up
measure: Hours of work per week among those who obtain competitive employment during the follow-up period
timeFrame: Measured at 18 month follow-up
measure: Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
timeFrame: Measured at 18 month follow-up
measure: Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
timeFrame: Measured at 18 month follow-up
measure: Functioning measured with Global Assessment of Functioning (GAF)
timeFrame: Measured at 18 month follow-up
measure: Functioning measured with Personal and Social Performance (PSP)
timeFrame: Measured at 18 month follow-up
measure: Quality of life measured with SF-12
timeFrame: Measured at 18 month follow-up
measure: Empowerment measured with Empowerment Scale
timeFrame: Measured at 18 month follow-up
measure: Self-efficacy measured with General self-efficacy scale (GSE)
timeFrame: Measured at 18 month follow-up
measure: Self-esteem measured with The Rosenberg Self-Esteem scale
timeFrame: Measured at 18 month follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Copenhagen University Hospital, Mental Health Centre Copenhagen
name: Lene F Eplov, MD, Phd
role: STUDY_DIRECTOR
affiliation: Copenhagen University Hospital, Mental Health Centre Copenhagen
name: Merete Nordentoft, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Odense, The University of Southern Denmark.
name: Elsebeth Stenager, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Odense, The University of Southern Denmark
name: Bent Nielsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen TN, Wallstrom IG, Stenager E, Bojesen AB, Gluud C, Nordentoft M, Eplov LF. Effects of Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training for People With Severe Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Dec 1;76(12):1232-1240. doi: 10.1001/jamapsychiatry.2019.2291.
citation: Christensen TN, Nielsen IG, Stenager E, Morthorst BR, Lindschou J, Nordentoft M, Eplov LF. Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:280. doi: 10.1186/s13063-015-0792-0.