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

Study Overview
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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.

Official Title
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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

Conditions
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Affective Disorder, Major Depressive Disorder, Bipolar Disorder, Anxiety Disorder

Intervention / Treatment
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* Behavioral: The IPS-MA method


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPS-MA<br>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<br>* 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.<br>* Other names: IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA);|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of competitive employment or studying | Information will be obtained from the Dream database. | 24 months | 
| Hamilton Rating Scale for Depression - 6 items | Level of symptoms of depression | 24 months | 
| Hamilton Rating Scale for anxiety -6 item scale | Level of symptoms of anxiety | 24 months | 
| Global Assessment of Function (GAF-F) | Level of function | 24 months | 
| WHO-5 well-being index | Level of health-related quality of life | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supported employment, Individual Placement and Support, Workability, Return to work