Clinical trial NCT01721824: The Effect of IPS-MA- a Modified Early Supported Employment Intervention for Individuals with Mood or Anxiety Disorders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorder
Major Depressive Disorder
Bipolar Disorder
Anxiety Disorder
Keywords: Supported employment
Individual Placement and Support
Workability
Return to work
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Competitive employment or education
timeFrame: 24 months
Secondary outcomes:
measure: Number of days of competitive employment or studying
timeFrame: 24 months
measure: Hamilton Rating Scale for Depression - 6 items
timeFrame: 24 months
measure: Hamilton Rating Scale for anxiety -6 item scale
timeFrame: 24 months
measure: Global Assessment of Function (GAF-F)
timeFrame: 24 months
measure: WHO-5 well-being index
timeFrame: 24 months
Other outcomes:
measure: Competitive employment or studying
timeFrame: 12 months
measure: Changing from matchgroup 2 or 3 to matchgroup 1
timeFrame: 12 and 24 months
measure: Number of days of competitive employment or studying
timeFrame: 12 and 24 months
measure: Time until returning to employment or education
timeFrame: 24 months
measure: Hamilton Rating Scale for Depression - 6 items
timeFrame: 12 months
measure: Hamilton Rating Scale for anxiety -6 item scale
timeFrame: 12 months
measure: The Bech-Rafaelsen Mania Scale (MAS)
timeFrame: 12 and 24 months
measure: Global Assessment of Function (GAF-F)
timeFrame: 12 months
measure: Personal and Social Performance (PSP)
timeFrame: 12 and 24 months
measure: WHO-5 well-being index
timeFrame: 12 months
measure: Sheehan Disability Scale (SDS)
timeFrame: 12 and 24 months
measure: The Empowerment Scale
timeFrame: 12 and 24 months
measure: The Changes Questionnaire
timeFrame: 12 and 24 months
measure: The Client Satisfaction Questionnaire
timeFrame: 12 and 24 months
Locations:
city: Ballerup
country: Denmark
facility: Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lene F Eplov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell K, Bond GR, Drake RE. Who benefits from supported employment: a meta-analytic study. Schizophr Bull. 2011 Mar;37(2):370-80. doi: 10.1093/schbul/sbp066. Epub 2009 Aug 6.
citation: Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.
citation: Hellstrom L, Madsen T, Nordentoft M, Eplov LF. Trajectories of symptoms of anxiety and depression among people on sick leave with mood or anxiety disorders: Secondary analysis from a randomized controlled trial. J Psychiatr Res. 2021 May;137:250-257. doi: 10.1016/j.jpsychires.2021.02.040. Epub 2021 Feb 25.
citation: Hellstrom L, Madsen T, Nordentoft M, Bech P, Eplov LF. Trajectories of Return to Work Among People on Sick Leave with Mood or Anxiety Disorders: Secondary Analysis from a Randomized Controlled Trial. J Occup Rehabil. 2018 Dec;28(4):666-677. doi: 10.1007/s10926-017-9750-x.
citation: Hellstrom L, Bech P, Hjorthoj C, Nordentoft M, Lindschou J, Eplov LF. Effect on return to work or education of Individual Placement and Support modified for people with mood and anxiety disorders: results of a randomised clinical trial. Occup Environ Med. 2017 Oct;74(10):717-725. doi: 10.1136/oemed-2016-104248. Epub 2017 May 25.
citation: Hellstrom L, Bech P, Nordentoft M, Lindschou J, Eplov LF. The effect of IPS-modified, an early intervention for people with mood and anxiety disorders: study protocol for a randomised clinical superiority trial. Trials. 2013 Dec 24;14:442. doi: 10.1186/1745-6215-14-442.