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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721824
• Other study ID #: H-2-2011-FSP20
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: July 6, 2016
• Start date: October 2011
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Mental Health Centre Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Affective Disorder
• Anxiety Disorder
• Anxiety Disorders
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders

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.

Locations

Country	Name	City	State
Denmark	Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland	Ballerup

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Centre Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290. Review. — View Citation

Campbell K, Bond GR, Drake RE. Who benefits from supported employment: a meta-analytic study. Schizophr Bull. 2011 Mar;37(2):370-80. doi: 10.1093/schbul/sbp066. Epub 2009 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Competitive employment or studying	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.	12 months	No
Other	Changing from matchgroup 2 or 3 to matchgroup 1	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.	12 and 24 months	No
Other	Number of days of competitive employment or studying	Information will be obtained from the Dream database.	12 and 24 months	No
Other	Time until returning to employment or education	Information will be obtained from the Dream database.	24 months	No
Other	Hamilton Rating Scale for Depression - 6 items	Level of symptoms of depression	12 months	No
Other	Hamilton Rating Scale for anxiety -6 item scale	Level of symptoms of anxiety	12 months	No
Other	The Bech-Rafaelsen Mania Scale (MAS)	Level of symptoms af mania	12 and 24 months	No
Other	Global Assessment of Function (GAF-F)	Level of function	12 months	No
Other	Personal and Social Performance (PSP)	Social performance in four domains (socailly usefull activities, personal and social relationships, self-care and disturbing and aggressive behaviour)	12 and 24 months	No
Other	WHO-5 well-being index	Level of health-related quality of life	12 months	No
Other	Sheehan Disability Scale (SDS)	Level of function regarding social relationships, work, spare time and family.	12 and 24 months	No
Other	The Empowerment Scale		12 and 24 months	No
Other	The Changes Questionnaire	Motivation to seeking employment or education	12 and 24 months	No
Other	The Client Satisfaction Questionnaire	Satisfaction with treatment	12 and 24 months	No
Primary	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	No
Secondary	Number of days of competitive employment or studying	Information will be obtained from the Dream database.	24 months	No
Secondary	Hamilton Rating Scale for Depression - 6 items	Level of symptoms of depression	24 months	No
Secondary	Hamilton Rating Scale for anxiety -6 item scale	Level of symptoms of anxiety	24 months	No
Secondary	Global Assessment of Function (GAF-F)	Level of function	24 months	No
Secondary	WHO-5 well-being index	Level of health-related quality of life	24 months	No