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

Not Applicable

Completed

• Conditions: Affective Disorder; Major Depressive Disorder; Bipolar Disorder; Anxiety Disorder
• Interventions: Behavioral: The IPS-MA method

• Registration Number: NCT01721824
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-06
• Primary Completion: 2016-03
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPS-MA	The IPS-MA method	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.

Primary Outcome Measures

Name	Time	Method
Competitive employment or education	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

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

Trial Locations

Locations (1)

Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland; 🇩🇰 Ballerup, Denmark