NCT01721824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

October 24, 2012

Last Update Submit

February 2, 2026

Conditions

Keywords

Supported employmentIndividual Placement and SupportWorkabilityReturn to work

Outcome Measures

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.

    24 months

Secondary Outcomes (5)

  • Number of days of competitive employment or studying

    24 months

  • Hamilton Rating Scale for Depression - 6 items

    24 months

  • Hamilton Rating Scale for anxiety -6 item scale

    24 months

  • Global Assessment of Function (GAF-F)

    24 months

  • WHO-5 well-being index

    24 months

Other Outcomes (14)

  • Competitive employment or studying

    12 months

  • Changing from matchgroup 2 or 3 to matchgroup 1

    12 and 24 months

  • Number of days of competitive employment or studying

    12 and 24 months

  • +11 more other outcomes

Study Arms (2)

IPS-MA

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

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)
IPS-MA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland

Ballerup Municipality, 2750, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 19661196BACKGROUND
  • 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.

    PMID: 18407876BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Mood DisordersDepressive Disorder, MajorBipolar DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersDepressive DisorderBipolar and Related Disorders

Study Officials

  • Lene F Eplov, MD, PhD

    Mental Health Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Associate professor

Study Record Dates

First Submitted

October 24, 2012

First Posted

November 6, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations