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Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial.

ABSTRACT: Depression 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.This 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.This 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.ClinicalTrials.gov, NCT02872051 . Retrospectively registered on 15 August 2016.

SUBMITTER: Poulsen R

PROVIDER: S-EPMC5712198 | 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 depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial.

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

Trials 20171202 1

<h4>Background</h4>Depression 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 serv ...[more]

PMID: 29197414

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Project description: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.

Project description:ObjectivesSick leave due to anxiety and depression is a heterogeneous process constituting a pressing public health issue. This longitudinal study aimed to identify sick leave trajectories among patients before, during and after work-focused treatment, in all 29.5 months. We then aimed to determine the background and clinical characteristics of these trajectory groups.MethodsBackground and clinical data were collected by patient self-report (N=619) in an observational study in a specialised mental healthcare clinic. Sick leave was recorded from national registry data. A latent growth mixture model identified trajectories. Multinomial logistic regression determined differences in background characteristics while a one-way analysis of variance (ANOVA) identified clinical differences.ResultsWe identified three trajectories: The 'Resilient' group (47.7%) had low sick leave throughout the period. The two other groups ('Recovery', 31.8% and 'High risk', 20.5%) had similar pretreatment trajectories: lower sick leave one year prior which increased to high sick leave at the start of treatment. After treatment, the 'Recovery' group made an almost full return to work while the 'High risk' group remained at high sick leave. The two groups with high sick leave had more women and higher age compared with the 'Resilient' group. All groups had similar clinical scores at the start of treatment, but the 'High risk' groups had residual depressive symptoms at the end of treatment. Effect sizes for anxiety and depression were moderate or large for all groups, (Cohen's d=0.74-1.81), and 87.2% of the total sample were fully working one year after treatment.ConclusionWe found three subgroups with distinctly different trajectories. Female gender and higher age were associated with high sick leave at the start of treatment, while residual depressive symptoms at the end of treatment predicted continued sick leave. The study points to the possibility of improving patient outcomes in the future by stratifying and tailoring treatment to patient characteristics.

Project description:BackgroundRetraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity.ObjectiveThe aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes).MethodsWe conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes.ResultsThis study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022).ConclusionsThe findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation.International registered report identifier (irrid)DERR1-10.2196/50200.

Dataset Information

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial.

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Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial.

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