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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Affective Disorder Anxiety Disorder Bipolar Disorder Major Depressive Disorder	Behavioral: The IPS-MA method Other Names IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)	N/A

Tracking Information

First Submitted Date	October 24, 2012
Last Update Posted Date	July 06, 2016
Start Date	October 01, 2011
Actual Completion Date	July 01, 2016
Primary Completion Date	March 01, 2016
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• 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.

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Number of days of competitive employment or studying [Time Frame: 24 months]

  Information will be obtained from the Dream database.

• Hamilton Rating Scale for Depression - 6 items [Time Frame: 24 months]

  Level of symptoms of depression

• Hamilton Rating Scale for anxiety -6 item scale [Time Frame: 24 months]

  Level of symptoms of anxiety

• Global Assessment of Function (GAF-F) [Time Frame: 24 months]

  Level of function

• WHO-5 well-being index [Time Frame: 24 months]

  Level of health-related quality of life

Original Secondary Outcome Measures

Study Design

Brief Title	The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders
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
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 Type	Interventional
Study Phase	N/A
Estimated Enrollment	326
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Single
Primary Purpose	Not Available
Conditions	Affective Disorder Anxiety Disorder Bipolar Disorder Major Depressive Disorder
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	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 Names IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)
Study Groups/Cohorts	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. 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.
Study Arms	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.

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.

Recruitment Information

Recruitment Status:	Completed
Enrollment	326
Completion Date	July 01, 2016
Eligibility 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
Gender	All
Age	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Denmark

Administrative Information

NCT Number:	NCT01721824
Other Study ID Numbers	H-2-2011-FSP20
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Lene Falgaard Eplov, Mental Health Centre Copenhagen
Study Sponsor	Mental Health Centre Copenhagen
Collaborators	Not Available
Investigators	Principal Investigator Lene F Eplov, MD, PhD Mental Health Center Copenhagen