ClinicalTrials.gg
CompletedNCT01721824Updated Feb 4, 2026

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

An interventional study of The IPS-MA method in Affective Disorder, Major Depressive Disorder and Bipolar Disorder, sponsored by Amager Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Amager Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Affective Disorder
  • Major Depressive Disorder
  • Bipolar Disorder
  • Anxiety Disorder

Keywords

  • Supported employment
  • Individual Placement and Support
  • Workability
  • Return to work
03

In context

Mood Disorders

561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.

This study's enrollment of 326 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.

Browse Mood Disorders studies →

Lead sponsor

Amager Hospital is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 verbally and in writing

Exclusion criteria

Exclusion Criteria:

  • A somatic disease that effects the workability
  • Substance og alcohol abuse
  • have a guardian or a forensic psychiatric arrangement
  • not given
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
326 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: The IPS-MA method

  • No intervention
    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.

Interventions

  • BehavioralThe 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.

    Also known as: IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)

06

What researchers measure

Primary outcomes

  1. Competitive employment or education

    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.

    Time frame: 24 months

Secondary outcomes

  1. Number of days of competitive employment or studying

    Information will be obtained from the Dream database.

    Time frame: 24 months

  2. Hamilton Rating Scale for Depression - 6 items

    Level of symptoms of depression

    Time frame: 24 months

  3. Hamilton Rating Scale for anxiety -6 item scale

    Level of symptoms of anxiety

    Time frame: 24 months

  4. Global Assessment of Function (GAF-F)

    Level of function

    Time frame: 24 months

  5. WHO-5 well-being index

    Level of health-related quality of life

    Time frame: 24 months

Other outcomes

  1. Competitive employment or studying

    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.

    Time frame: 12 months

  2. Changing from matchgroup 2 or 3 to matchgroup 1

    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.

    Time frame: 12 and 24 months

  3. Number of days of competitive employment or studying

    Information will be obtained from the Dream database.

    Time frame: 12 and 24 months

  4. Time until returning to employment or education

    Information will be obtained from the Dream database.

    Time frame: 24 months

  5. Hamilton Rating Scale for Depression - 6 items

    Level of symptoms of depression

    Time frame: 12 months

  6. Hamilton Rating Scale for anxiety -6 item scale

    Level of symptoms of anxiety

    Time frame: 12 months

  7. The Bech-Rafaelsen Mania Scale (MAS)

    Level of symptoms af mania

    Time frame: 12 and 24 months

  8. Global Assessment of Function (GAF-F)

    Level of function

    Time frame: 12 months

  9. Personal and Social Performance (PSP)

    Social performance in four domains (socailly usefull activities, personal and social relationships, self-care and disturbing and aggressive behaviour)

    Time frame: 12 and 24 months

  10. WHO-5 well-being index

    Level of health-related quality of life

    Time frame: 12 months

  11. Sheehan Disability Scale (SDS)

    Level of function regarding social relationships, work, spare time and family.

    Time frame: 12 and 24 months

  12. The Empowerment Scale

    Time frame: 12 and 24 months

  13. The Changes Questionnaire

    Motivation to seeking employment or education

    Time frame: 12 and 24 months

  14. The Client Satisfaction Questionnaire

    Satisfaction with treatment

    Time frame: 12 and 24 months

07

Study locations

1 site
  • Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland
    Ballerup Municipality, 2750, Denmark
08

References and documents

Publications

  • 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. PubMed 19661196 ↗
  • 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. PubMed 18407876 ↗
  • Hellstrom L, Christensen TN, Bojesen AB, Eplov LF. Predictors of Return to Work for People with Anxiety or Depression Participating in a Randomized Trial Investigating the Effect of a Supported Employment Intervention. J Occup Rehabil. 2023 Mar;33(1):61-70. doi: 10.1007/s10926-022-10046-7. Epub 2022 May 25. PubMed 35612640 ↗
  • 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. PubMed 33714077 ↗
  • 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. PubMed 29282650 ↗
  • 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. PubMed 28546319 ↗
  • 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. PubMed 24368060 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01721824
Lead sponsor
Amager Hospital
Responsible party
Lene Falgaard Eplov (Head of Research, Associate professor, Amager Hospital) — Principal investigator
First posted
Nov 6, 2012
Start date
Oct 2011
Primary completion
Mar 2016
Completion
Jul 2016
Last update
Feb 4, 2026

Study contacts

Lene F Eplov, MD, PhD
principal investigator · Mental Health Center Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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