Major Depressive Disorder Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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