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The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders

6 juli 2016 bijgewerkt door: Lene Falgaard Eplov, Mental Health Centre Copenhagen

IPS-MA - A Randomized Clinical Trial Examining the Effect of a Modified IPS Intervention in Addition to Treatment as Usual Versus Treatment as Usual Alone for Individuals With Mood or Anxiety Disorders

The aim of the present study, is to evaluate the effect of a supported employment intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or education, when offered to people with onset mood or anxiety disorders who are not likely to be able to return to work within three month.

The hypothesis is that the IPS-MA method is associated with a shorter recovery period and more people returning to work or education, compared to treatment as usual.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background: The IPS-MA method is a modified Individual Placement and Support (IPS) intervention, aiming at supporting people with mood or anxiety disorders regain their workability and return to work or education. Previous studies have showed, that IPS has an effect on employment when offered to people with severe mental illness. Further studies are crucial to demonstrate whether the modified IPS, the IPS-MA method, has an effect when offered to people with mood or anxiety disorders who are not yet chronified.

Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the IPS-MA method in addition to treatment as usual compared to treatment as usual alone for 326 participants diagnosed with a mood or anxiety disorder, living in the Capital Region of Denmark. The primary outcome is competitive employment or education. Secondary outcomes are days of competitive employment or education, disease symptoms, level of functioning, and quality of life at follow-up 12 and 24 months after baseline.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

326

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Ballerup, Denemarken, 2750
        • Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Diagnosed following the International Classification of Diseases (ICD-10) criteria of affective disorder (F30-39) or anxiety disorder (F40-41)
  • Not able to work within 3 months
  • Associated with the Mental Health Center Copenhagen, Frederiksberg, Hillerød, Hvidovre or Ballerup
  • Only having had contact to the Mental Health services during the past 3 years
  • Having had competitive employment or attending a study within the past two years.
  • Has returning to work or education as an important goal
  • Under the age of 60
  • Able to speak, read and understand danish
  • Has given informed consent verbally and in writing

Exclusion Criteria:

  • A somatic disease that effects the workability
  • Substance og alcohol abuse
  • have a guardian or a forensic psychiatric arrangement
  • not given informed consent

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: IPS-MA

The IPS-MA method consists of five basic services for the participants. 1)Individual mentor support, based on psychiatric knowledge. 2)Coordination by the mentor of activities, internal as well as from external providers. 3)Career counseling aimed at people with mental illnesses. 4)Impartial help to clarify private economy. 5) Contact to employers to help participants obtain jobs, and keep them.

Participants will receive the IPS-MA method in addition to treatment as usual.
Gedragsmatig: The IPS-MA method
During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the IPS-MA intervention is 12 months, but since the needs of the participants are very individual, this may vary.
Andere namen:
  • IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)
Geen tussenkomst: Control group
Participants randomised to the control group will receive "treatment as usual" only. This means the standard support offered by the social- and health services in Denmark.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Competitive employment or education
Tijdsspanne: 24 months
Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy job. Information on employment and education will be extracted from the DREAM database. This database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.
24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of days of competitive employment or studying
Tijdsspanne: 24 months
Information will be obtained from the Dream database.
24 months
Hamilton Rating Scale for Depression - 6 items
Tijdsspanne: 24 months
Level of symptoms of depression
24 months
Hamilton Rating Scale for anxiety -6 item scale
Tijdsspanne: 24 months
Level of symptoms of anxiety
24 months
Global Assessment of Function (GAF-F)
Tijdsspanne: 24 months
Level of function
24 months
WHO-5 well-being index
Tijdsspanne: 24 months
Level of health-related quality of life
24 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Competitive employment or studying
Tijdsspanne: 12 months
Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy jobs. Information on employment and education will be extracted from the DREAM database. The database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.
12 months
Changing from matchgroup 2 or 3 to matchgroup 1
Tijdsspanne: 12 and 24 months
If participants are matchgroup 2 or 3, they are not able to go back to work within the following 3 months. If participants are matchgroup 1, they should be actively seeking jobs.
12 and 24 months
Number of days of competitive employment or studying
Tijdsspanne: 12 and 24 months
Information will be obtained from the Dream database.
12 and 24 months
Time until returning to employment or education
Tijdsspanne: 24 months
Information will be obtained from the Dream database.
24 months
Hamilton Rating Scale for Depression - 6 items
Tijdsspanne: 12 months
Level of symptoms of depression
12 months
Hamilton Rating Scale for anxiety -6 item scale
Tijdsspanne: 12 months
Level of symptoms of anxiety
12 months
The Bech-Rafaelsen Mania Scale (MAS)
Tijdsspanne: 12 and 24 months
Level of symptoms af mania
12 and 24 months
Global Assessment of Function (GAF-F)
Tijdsspanne: 12 months
Level of function
12 months
Personal and Social Performance (PSP)
Tijdsspanne: 12 and 24 months
Social performance in four domains (socailly usefull activities, personal and social relationships, self-care and disturbing and aggressive behaviour)
12 and 24 months
WHO-5 well-being index
Tijdsspanne: 12 months
Level of health-related quality of life
12 months
Sheehan Disability Scale (SDS)
Tijdsspanne: 12 and 24 months
Level of function regarding social relationships, work, spare time and family.
12 and 24 months
The Empowerment Scale
Tijdsspanne: 12 and 24 months
12 and 24 months
The Changes Questionnaire
Tijdsspanne: 12 and 24 months
Motivation to seeking employment or education
12 and 24 months
The Client Satisfaction Questionnaire
Tijdsspanne: 12 and 24 months
Satisfaction with treatment
12 and 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mental Health Centre Copenhagen

Onderzoekers

  • Hoofdonderzoeker: Lene F Eplov, MD, PhD, Mental Health Center Copenhagen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2011

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 juli 2016

Studieregistratiedata

Eerst ingediend

24 oktober 2012

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2012

Eerst geplaatst (Schatting)

6 november 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

7 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

6 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H-2-2011-FSP20

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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