title: Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Individual Placement and Support (IPS) appears to be an effective vocational intervention for obtaining competitive employment for people with severe mental illness. However, no IPS studies or trials have been conducted in Denmark, a country characterized by a specialized labor market with a higher minimum wage and fewer entry-level jobs in comparison with other countries such as the US. Furthermore, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Integrating methods such as cognitive remediation and work-related social skills training may be ways to address these issues.
  
  
  METHODS
  The trial design is an investigator-initiated, randomized, assessor-blinded, multi-center trial. A total of 750 patients with severe mental illness will be randomly assigned into three groups: (1) IPS, (2) IPS enhanced with cognitive remediation and work-related social skills training, and (3) service as usual. The primary outcome is number of hours in competitive employment or education at 18-month follow-up. Secondary and exploratory outcomes are money earned, days to first employment, symptoms, functional level, self-esteem, and self-efficacy at 18-month follow-up. Thirty- and 60-month follow-ups will be register-based.
  
  
  CONCLUSIONS
  This will be one of the largest randomized trials investigating IPS to date. The trial will be conducted with high methodological quality in order to reduce the risk of bias. If the results of this trial show that IPS, or IPS enhanced with cognitive remediation and work-related social skills training, is superior to service as usual, this will support preliminary evidence. Furthermore, it will show that the method is generalizable to a variety of labor markets and welfare systems and provide important knowledge about the effect of adding cognitive remediation and social skills training to the IPS intervention.
  
  
  BACKGROUND
  ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).
authors.affiliation: Mental Health Center Copenhagen, Mental Health Services Capital region of Denmark, University of Copenhagen, Kildegårdsvej 28, Opg.15.4, DK-2900, Hellerup, Copenhagen, Denmark. thomas.03.christensen@regionh.dk.
authors.forename: Thomas Nordahl
authors.initials: TN
authors.lastname: Christensen
authors.affiliation: Department of Psychiatry, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark. iben.gammelgard.nielsen@rsyd.dk.
authors.forename: Iben Gammelgaard
authors.initials: IG
authors.lastname: Nielsen
authors.affiliation: Department of Psychiatry, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark. elsebeth.stenager@rsyd.dk.
authors.forename: Elsebeth
authors.initials: E
authors.lastname: Stenager
authors.affiliation: Mental Health Center Copenhagen, Mental Health Services Capital region of Denmark, University of Copenhagen, Kildegårdsvej 28, Opg.15.4, DK-2900, Hellerup, Copenhagen, Denmark. britt.reuter.morthorst@regionh.dk.
authors.forename: Britt Reuter
authors.initials: BR
authors.lastname: Morthorst
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Department 7812 Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen Ø, Denmark. jl@ctu.dk.
authors.forename: Jane
authors.initials: J
authors.lastname: Lindschou
authors.affiliation: Mental Health Center Copenhagen, Mental Health Services Capital region of Denmark, University of Copenhagen, Kildegårdsvej 28, Opg.15.4, DK-2900, Hellerup, Copenhagen, Denmark. merete.nordentoft@regionh.dk.
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
authors.affiliation: Mental Health Center Copenhagen, Mental Health Services Capital region of Denmark, University of Copenhagen, Kildegårdsvej 28, Opg.15.4, DK-2900, Hellerup, Copenhagen, Denmark. lene.falgaard.eplov@regionh.dk.
authors.forename: Lene Falgaard
authors.initials: LF
authors.lastname: Eplov
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003718:Denmark; D004495:Education of Persons with Intellectual Disabilities; D016832:Employment, Supported / Q000523:psychology*; D005260:Female; D006801:Humans; D007587:Job Description; D008297:Male; D001523:Mental Disorders / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation*; D008875:Middle Aged; D019989:Persons with Intellectual Disabilities / Q000523:psychology / Q000534:rehabilitation*; D012050:Rehabilitation, Vocational / Q000379:methods*; D012107:Research Design; D012649:Self Concept; D020377:Self Efficacy; D066107:Social Skills; D013997:Time Factors; D016896:Treatment Outcome; D014829:Vocational Education; D055815:Young Adult