Skip to main content
OpenTrials
Completed

NCT Number: NCT01721824

The Effect of IPS-MA- A Modified Early Supported Employment Intervention 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Affective Disorder Anxiety Disorder Anxiety Disorders Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ballerup Municipality, 2750, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The IPS-MA method

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.

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

Primary outcomes

  1. Competitive employment or education

    Time frame: 24 months

    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.

Secondary outcomes

  1. Number of days of competitive employment or studying

    Time frame: 24 months

    Information will be obtained from the Dream database.

  2. Hamilton Rating Scale for Depression - 6 items

    Time frame: 24 months

    Level of symptoms of depression

  3. Hamilton Rating Scale for anxiety -6 item scale

    Time frame: 24 months

    Level of symptoms of anxiety

  4. Global Assessment of Function (GAF-F)

    Time frame: 24 months

    Level of function

  5. WHO-5 well-being index

    Time frame: 24 months

    Level of health-related quality of life

Other outcomes

  1. Competitive employment or studying

    Time frame: 12 months

    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.

  2. Changing from matchgroup 2 or 3 to matchgroup 1

    Time frame: 12 and 24 months

    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.

  3. Number of days of competitive employment or studying

    Time frame: 12 and 24 months

    Information will be obtained from the Dream database.

  4. Time until returning to employment or education

    Time frame: 24 months

    Information will be obtained from the Dream database.

  5. Hamilton Rating Scale for Depression - 6 items

    Time frame: 12 months

    Level of symptoms of depression

  6. Hamilton Rating Scale for anxiety -6 item scale

    Time frame: 12 months

    Level of symptoms of anxiety

  7. The Bech-Rafaelsen Mania Scale (MAS)

    Time frame: 12 and 24 months

    Level of symptoms af mania

  8. Global Assessment of Function (GAF-F)

    Time frame: 12 months

    Level of function

  9. Personal and Social Performance (PSP)

    Time frame: 12 and 24 months

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

  10. WHO-5 well-being index

    Time frame: 12 months

    Level of health-related quality of life

  11. Sheehan Disability Scale (SDS)

    Time frame: 12 and 24 months

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

  12. The Empowerment Scale

    Time frame: 12 and 24 months

  13. The Changes Questionnaire

    Time frame: 12 and 24 months

    Motivation to seeking employment or education

  14. The Client Satisfaction Questionnaire

    Time frame: 12 and 24 months

    Satisfaction with treatment

Sponsors and collaborators

Lead sponsor

Amager Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2012
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.