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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01721824
Other study ID # H-2-2011-FSP20
Secondary ID
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)


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
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