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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.

ABSTRACT: Common mental disorders are important contributors to the global burden of disease and cause negative effects on both the individual and society. Stress-related disorders influence the individual's workability and cause early retirement pensions in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this group. Integrated vocational and health care services have shown good effects on return to work in other similar welfare contexts. The purpose of the Danish IBBIS (Integreret Behandlings- og BeskæftigelsesIndsats til Sygemeldte) study is to examine the efficacy of (1) a stepped mental health care intervention with individual stress coaching and/or group-based MBSR and (2) an integrated stepped mental health care with individual stress coaching and/or group-based MBSR and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark.This three-armed, parallel-group, randomized superiority trial is set up to investigate the effectiveness of a stepped mental health care intervention and an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark. The trial has an investigator-initiated multicenter design. Six hundred and three patients will be recruited from Danish vocational rehabilitation centers in four municipalities and randomly assigned into three groups: (1) IBBIS mental health care integrated with IBBIS vocational rehabilitation, (2) IBBIS mental health care and standard vocational rehabilitation, and (3) standard mental health care and standard vocational rehabilitation. The primary outcome is register-based return to work at 12 months. The secondary outcome measures are self-assessed level of depression (BDI), anxiety (BAI), distress symptoms (4DSQ), work- and social functioning (WSAS), and register-based recurrent sickness absence.This study will contribute with knowledge on the consequence of the current organizational separation of health care interventions and vocational rehabilitation regarding the individual's process of returning to work after sick leave because of exhaustion disorder, adjustment disorder or distress. If the effect on return to work, symptom level, and recurrent sick leave is different in the intervention groups, this study can contribute with new knowledge on shared care models and the potential for preventing deterioration in stress symptoms, prolonged sick leave, and recurrent sick leave.ClinicalTrials.gov, registration number: NCT02885519 . Retrospectively registered on 15 August 2016). Participants have been included in the IBBIS trial for distress, adjustment disorder and exhaustion disorder since April 2016.

SUBMITTER: Poulsen R

PROVIDER: S-EPMC5712165 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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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.

Poulsen Rie R Fisker Jonas J Hoff Andreas A Hjorthøj Carsten C Eplov Lene Falgaard LF

Trials 20171202 1

<h4>Background</h4>Common mental disorders are important contributors to the global burden of disease and cause negative effects on both the individual and society. Stress-related disorders influence the individual's workability and cause early retirement pensions in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this group. Integrated vocational and health care services have shown good effects on return to work in ot ...[more]

PMID: 29197404

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Project description:BackgroundDepression and anxiety are among the largest contributors to the global burden of disease and have negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's work ability, and up to 40% of the people on sick leave in Denmark have depression and/or anxiety. There is no clear evidence that treatment alone will provide sufficient support for vocational recovery in this group. Integrated vocational and health care services have shown good effects on return to work in other, similar welfare contexts. The purpose of the IBBIS (Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression) interventions is to improve and hasten the process of return to employment for people in Denmark on sick leave because of depression and anxiety.Methods/designThis three-arm, parallel-group, randomized superiority trial has been set up to investigate the effectiveness of the IBBIS mental health care intervention and the integrated IBBIS mental health care and IBBIS vocational rehabilitation intervention for people on sick leave because of depression and/or anxiety in Denmark. The trial has an investigator-initiated multicenter design. A total of 603 patients will be recruited from Danish job centers in 4 municipalities and randomly assigned to one of 3 groups: (1) IBBIS mental health care integrated with IBBIS vocational rehabilitation, (2) IBBIS mental health care and standard vocational rehabilitation, and (3) standard mental health care and standard vocational rehabilitation. The primary outcome is register-based return to work at 12 months. The secondary outcome measures are self-assessed level of depression (Beck Depression Inventory II), anxiety (Beck Anxiety Inventory), stress symptoms (Four-Dimensional Symptom Questionnaire), work and social functioning (Work and Social Adjustment Scale), and register-based recurrent sickness absence.DiscussionThis study will provide new knowledge on vocational recovery, integrated vocational and health care interventions, and prevention of recurrent sickness absence among people with depression and anxiety. If the effect on return to work is different in the intervention groups, this study can contribute to current knowledge on shared care models for health care and vocational rehabilitation services.Trial registrationClinicalTrials.gov, NCT02872051 . Retrospectively registered on 15 August 2016.

Project description:Sickness absence due to poor mental health is a common problem in many Western countries. To facilitate return to work, it may be important to identify individuals on sick leave and at risk of having a mental disorder and subsequently to offer appropriate treatment. Psychoeducation alone has not previously been used as a return to work intervention, but may be a promising tool to facilitate return to work. Therefore, the aim of the study is to evaluate the effectiveness of psychoeducation designed specifically to facilitate return to work for individuals on sick leave and at risk of having a mental disorder. The psychoeducation was a supplement to the various standard offers provided by the job centres.The study is a randomised controlled trial, in which individuals on sick leave either receive psychoeducation and standard case management or standard case management alone. Participants were individuals with mental health symptoms, who had been on sick leave from part-time or full-time work or unemployment for about 4-8 weeks. The psychoeducational intervention was group-based and the course consisted of 2 hour sessions once a week for 6 weeks. The course was given by psychiatric nurses, a psychologist, a social worker, a physiotherapist and a person who had previously been on sick leave due to mental health problems. The sessions focused on stress and work life, and the purpose was to provide individuals on sick leave the skills to understand and improve their mental functioning.The primary outcome is the duration of sickness absence measured by register data. Secondary outcomes include psychological symptoms, mental health-related quality of life, and locus of control. These outcomes are measured by questionnaires at the start of the intervention and at 3 and 6 months follow-up.On the basis of this trial, the effect of psychoeducation for individuals on sick leave and at risk of having a mental disorder will be studied. The results will contribute to the continuing research on sickness absence and mental health. It will primarily show whether psychoeducation can lead to faster and sustainable return to work.Clinical Trial.gov NCT01637363. Registered 6 July 2012.

Project description:ObjectivesLittle is known about the prognosis of community-acquired bacteraemia (CAB) in workforce adults. We assessed return to workforce, risk for sick leave, disability pension and mortality within 1 year after CAB in workforce adults compared with blood culture-negative controls and population controls.DesignPopulation-based cohort study.SettingNorth Denmark, 1996-2011.ParticipantsWe used population-based healthcare registries to identify all patients aged 20-58 years who had first-time blood cultures obtained within 48 h of medical hospital admission, and who were part of the workforce (450 bacteraemia exposed patients and 6936 culture-negative control patients). For each bacteraemia patient, we included up to 10 matched population controls.Primary and secondary outcome measuresReturn to workforce, risk of sick leave, permanent disability pension and mortality within 1 year after bacteraemia. Regression analyses were used to compute adjusted relative risks (RRs) with 95% CIs.ResultsOne year after admission, 78% of patients with CAB, 85.7% of culture-negative controls and 96.8% of population controls were alive and in the workforce, and free from sick leave or disability pension. Compared with culture-negative controls, bacteraemia was associated with an increased risk for long-term sick leave (4-week duration, 40.2% vs 23.9%, adjusted RR, 1.51; CI 1.34 to 1.70) and an increased risk for mortality (30-day mortality, 4% vs 1.4%, adjusted RR, 2.34, CI 1.22 to 4.50; 1-year mortality, 8% vs 3.9%, adjusted RR, 1.73; CI 1.18 to 2.55). Bacteraemia patients had a risk for disability pension similar to culture-negative controls (2.7% vs 2.6%, adjusted RR, 0.99, CI 0.48 to 2.02) but greater than population controls (adjusted RR, 5.20; 95% CI 2.16 to 12.50).ConclusionsCAB is associated with long duration of sick leave and considerable mortality in working-age adults when compared with blood culture-negative controls, and an increased 1-year risk for disability pension when compared with population controls.

Dataset Information

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.

Publications

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.

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