We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01721824
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Affective Disorder Major Depressive Disorder Bipolar Disorder Anxiety Disorder Behavioral: The IPS-MA method Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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 Start Date : October 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
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 Name: IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721824


Locations
Layout table for location information
Denmark
Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland
Ballerup, Denmark, 2750
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Lene F Eplov, MD, PhD Mental Health Center Copenhagen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Lene Falgaard Eplov, Senior consultant, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT01721824    
Other Study ID Numbers: H-2-2011-FSP20
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lene Falgaard Eplov, Mental Health Centre Copenhagen:
Supported employment
Individual Placement and Support
Workability
Return to work
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
 Mood Disorders
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders