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

NCT ID: NCT01721824

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Affective Disorder Major Depressive Disorder Bipolar Disorder Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

The IPS-MA method

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amager Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lene Falgaard Eplov

Head of Research, Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene F Eplov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Center Copenhagen

Locations

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

Ballerup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 19661196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18407876 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35612640 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33714077 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29282650 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28546319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24368060 (View on PubMed)

Other Identifiers

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H-2-2011-FSP20

Identifier Type: -

Identifier Source: org_study_id

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