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| Name | Class |
|---|---|
| The Danish Agency for Labour Market and Recruitment | OTHER |
| Copenhagen Municipality, Denmark | OTHER_GOV |
| Gentofte Municipality, Denmark | UNKNOWN |
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The purpose of this study is to investigate the efficacy of 1) a stepped mental health care (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark
Background:
Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.
Objective:
The purpose of the Danish IBBIS study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark.
Method:
This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is return to work at 12 months.
Results/discussion:
This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard treatment and standard vocational rehabilitation | |
| IBBIS MHC | Experimental | IBBIS mental health care and standard vocational rehabilitation |
|
| IBBIS integrated MCH and VR | Experimental | Integrated mental health care and vocational rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBBIS mental health care and standard vocational rehabilitation | Behavioral | Standard vocational rehabilitation. Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists and medical doctors) with the treatment modalities: Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to return to work | Time from baseline to first return to work for more than four consecutive weeks | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Work | Competitive work 12 months after baseline (yes/no) | 12 months |
| Time to return to work | Time from baseline to first return to work for more than four consecutive weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom level | Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ) | 6, 12 and 24 months |
| Death | Death and cause of death by register data |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Services of the Capital Region of Denmark | Copenhagen | Capital Region of Denmark | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36871310 | Derived | Hoff A, Poulsen RM, Fisker JP, Hjorthoj C, Nordentoft M, Bojesen AB, Eplov LF. Integrated mental healthcare and vocational rehabilitation for people on sick leave with stress-related disorders: 24-month follow-up of the randomized IBBIS trial. Scand J Work Environ Health. 2023 May 1;49(4):303-308. doi: 10.5271/sjweh.4084. Epub 2023 Mar 5. | |
| 29197404 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2019 | Aug 20, 2019 |
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| Municipality of Lyngby-Taarbæk, Denmark |
| UNKNOWN |
| Gladsaxe Municipality, Denmark | OTHER |
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|
| Integrated mental health care and vocational rehabilitation | Behavioral | Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors). Mental health care is provided according to a stepped care model with the following treatment modalities: Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element |
|
| 24 months |
| Recurrent Sickness Absence | Time from baseline to recurrent sickness absence for more than 8 weeks | 24 months |
| Degree of depressive symptoms | Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI) | 6 months |
| Degree of anxiety symptoms | Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI) | 6 months |
| Degree of psychological stress symptoms | Self-assessed psychological stress by the Cohen perceived stress scale (PSS) | 6 months |
| Work and social functioning | Work and social functioning by the Work and Social Adjustment Scale (WSAS) | 6 months |
| 6, 12 and 24 months |
| Suicidal ideation | Suicidal ideation by BDI | 6, 12 and 24 months |
| Life-threatening conditions | Life-threatening conditions by register data | 6, 12 and 24 months |
| Poulsen R, Fisker J, Hoff A, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):579. doi: 10.1186/s13063-017-2273-0. |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2020 | Dec 1, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000275 | Adjustment Disorders |
| D000077062 | Burnout, Psychological |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012050 | Rehabilitation, Vocational |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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