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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPS-MA | Experimental | 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 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The IPS-MA method | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene F Eplov, MD, PhD | Mental Health Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland | Ballerup Municipality | 2750 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19661196 | Background | 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. | |
| 18407876 | Background | 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. |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D000068105 | Bipolar and Related Disorders |
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| 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 |
| 12 months |
| 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 |
| Number of days of competitive employment or studying | Information will be obtained from the Dream database. | 12 and 24 months |
| Time until returning to employment or education | Information will be obtained from the Dream database. | 24 months |
| Hamilton Rating Scale for Depression - 6 items | Level of symptoms of depression | 12 months |
| Hamilton Rating Scale for anxiety -6 item scale | Level of symptoms of anxiety | 12 months |
| The Bech-Rafaelsen Mania Scale (MAS) | Level of symptoms af mania | 12 and 24 months |
| Global Assessment of Function (GAF-F) | Level of function | 12 months |
| 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 |
| WHO-5 well-being index | Level of health-related quality of life | 12 months |
| Sheehan Disability Scale (SDS) | Level of function regarding social relationships, work, spare time and family. | 12 and 24 months |
| The Empowerment Scale | 12 and 24 months |
| The Changes Questionnaire | Motivation to seeking employment or education | 12 and 24 months |
| The Client Satisfaction Questionnaire | Satisfaction with treatment | 12 and 24 months |
| 35612640 | Derived | Hellstrom L, Christensen TN, Bojesen AB, Eplov LF. Predictors of Return to Work for People with Anxiety or Depression Participating in a Randomized Trial Investigating the Effect of a Supported Employment Intervention. J Occup Rehabil. 2023 Mar;33(1):61-70. doi: 10.1007/s10926-022-10046-7. Epub 2022 May 25. |
| 33714077 | Derived | Hellstrom L, Madsen T, Nordentoft M, Eplov LF. Trajectories of symptoms of anxiety and depression among people on sick leave with mood or anxiety disorders: Secondary analysis from a randomized controlled trial. J Psychiatr Res. 2021 May;137:250-257. doi: 10.1016/j.jpsychires.2021.02.040. Epub 2021 Feb 25. |
| 29282650 | Derived | Hellstrom L, Madsen T, Nordentoft M, Bech P, Eplov LF. Trajectories of Return to Work Among People on Sick Leave with Mood or Anxiety Disorders: Secondary Analysis from a Randomized Controlled Trial. J Occup Rehabil. 2018 Dec;28(4):666-677. doi: 10.1007/s10926-017-9750-x. |
| 28546319 | Derived | Hellstrom L, Bech P, Hjorthoj C, Nordentoft M, Lindschou J, Eplov LF. Effect on return to work or education of Individual Placement and Support modified for people with mood and anxiety disorders: results of a randomised clinical trial. Occup Environ Med. 2017 Oct;74(10):717-725. doi: 10.1136/oemed-2016-104248. Epub 2017 May 25. |
| 24368060 | Derived | Hellstrom L, Bech P, Nordentoft M, Lindschou J, Eplov LF. The effect of IPS-modified, an early intervention for people with mood and anxiety disorders: study protocol for a randomised clinical superiority trial. Trials. 2013 Dec 24;14:442. doi: 10.1186/1745-6215-14-442. |