Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Cognition* ; Social Skills*; Cognitive Behavioral Therapy/*methods ; Employment, Supported/*psychology ; Mental Disorders/*rehabilitation ; Persons with Mental Disabilities/*rehabilitation ; Rehabilitation, Vocational/*methods; Adaptation, Psychological ; Adolescent ; Adult ; Aged ; Denmark ; Education of Intellectually Disabled ; Female ; Humans ; Job Description ; Male ; Mental Disorders/diagnosis ; Mental Disorders/psychology ; Middle Aged ; Persons with Mental Disabilities/psychology ; Research Design ; Self Concept ; Self Efficacy ; Time Factors ; Treatment Outcome ; Vocational Education ; Young Adult

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/design: 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.
Discussion: 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.
Trial Registration: ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).

Ann Med. 2001 Jul;33(5):337-43. (PMID: 11491192)
Aust N Z J Psychiatry. 2010 Jun;44(6):495-504. (PMID: 20482409)
J Consult Clin Psychol. 1996 Apr;64(2):391-9. (PMID: 8871423)
World Psychiatry. 2012 Feb;11(1):32-9. (PMID: 22295007)
Psychiatry Res. 2008 Nov 30;161(2):213-24. (PMID: 18848731)
Aust N Z J Psychiatry. 2010 Jan;44(1):49-58. (PMID: 20073567)
Am J Psychiatry. 2007 Mar;164(3):437-41. (PMID: 17329468)
Lancet. 2007 Sep 29;370(9593):1146-52. (PMID: 17905167)
Psychiatr Serv. 1997 Aug;48(8):1042-7. (PMID: 9255837)
Schizophr Bull. 2010 Jan;36(1):48-70. (PMID: 19955389)
Ann Intern Med. 2008 Feb 19;148(4):295-309. (PMID: 18283207)
Compr Psychiatry. 2007 Jan-Feb;48(1):88-94. (PMID: 17145287)
Cochrane Database Syst Rev. 2013;9:CD008297. (PMID: 24030739)
Arch Gen Psychiatry. 1999 Jul;56(7):627-33. (PMID: 10401508)
Adm Policy Ment Health. 2014 Jan;41(1):69-73. (PMID: 23161326)
Schizophr Bull. 2005 Oct;31(4):898-909. (PMID: 16079391)
Br J Psychiatry. 2010 May;196(5):404-11. (PMID: 20435968)
Ment Health Serv Res. 2004 Mar;6(1):9-21. (PMID: 15002677)
J Consult Clin Psychol. 2004 Jun;72(3):479-90. (PMID: 15279531)
Med Care. 1996 Mar;34(3):220-33. (PMID: 8628042)
Schizophr Res. 2000 Oct 27;45(3):175-84. (PMID: 11042435)
Br J Psychiatry. 2007 Jul;191:30-7. (PMID: 17602122)
J Psychol. 2005 Sep;139(5):439-57. (PMID: 16285214)
BMJ. 2001 Jan 27;322(7280):204-8. (PMID: 11159616)
Psychiatr Rehabil J. 2004 Spring;27(4):345-59. (PMID: 15222147)
Qual Life Res. 2008 Dec;17(10):1247-56. (PMID: 18855124)
Schizophr Bull. 2011 Mar;37(2):370-80. (PMID: 19661196)
Psychiatr Serv. 2012 Aug;63(8):758-63. (PMID: 22660842)
Arch Gen Psychiatry. 1990 Jun;47(6):589-93. (PMID: 2190539)
J Behav Ther Exp Psychiatry. 2009 Jun;40(2):292-305. (PMID: 19154992)
Psychiatr Rehabil J. 2008 Spring;31(4):280-90. (PMID: 18407876)
Eur Psychiatry. 2007 May;22(4):252-5. (PMID: 17344030)
Eval Program Plann. 1982;5(3):233-7. (PMID: 10259963)
J Clin Exp Neuropsychol. 2006 Feb;28(2):260-9. (PMID: 16484097)
BMJ. 2013;346:e7586. (PMID: 23303884)

ClinicalTrials.gov NCT01722344

Date Created: 20150622 Date Completed: 20160225 Latest Revision: 20201209

20240628

PMC4479316

10.1186/s13063-015-0792-0

26093636