Dataset Information

Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial.

ABSTRACT:

Background

Mental illness has an estimated financial burden on the Danish economy of 3.4% of the gross national product every year due to lost productivity, social benefits, and healthcare costs, and approximately 50% of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% are treated for their mental illness. The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders, or functional disorders return to work faster and have higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.

Methods

The trial is designed as an investigator-initiated, randomized, two-group parallel, assessor-blinded, superior trial. A total of 900 participants with a common mental illness will randomly be assigned into two groups: (1) IBBIS-II, consisting of integrated mental health care and vocational rehabilitation, or (2) service as usual (SAU), at two sites in Denmark. The primary outcome is the difference between the two groups in time to return to work (RTW) at 12 months using data from the Danish Register for Evaluation of Marginalization (DREAM) database.

Discussion

This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.

Trial registration

ClinicalTrials.gov NCT04432129 . Registered on June 16, 2020.

SUBMITTER: Christensen TN

PROVIDER: S-EPMC9522440 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial.

Christensen Thomas Nordahl TN Poulsen Chalotte Heinsvig CH Ebersbach Bea Kolbe BK Eplov Lene Falgaard LF

Trials 20220930 1

<h4>Background</h4>Mental illness has an estimated financial burden on the Danish economy of 3.4% of the gross national product every year due to lost productivity, social benefits, and healthcare costs, and approximately 50% of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% are treated for their mental illness. The primary objective of the randomized trial is to examine whether people on sick leave w ...[more]

PMID: 36175977

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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:With the overall objective of providing implication for clinical and research practices regarding the identification and measurement of modifiable predicting factors for return to work (RTW) in people with musculoskeletal disorders (MSDs) and common mental disorders (CMDs), this study 1) systematically examined and synthetized the research evidence available in the literature on the topic, and 2) critically evaluated the tools used to measure each identified factor. A systematic search of prognostic studies was conducted, considering four groups of keywords: 1) population (i.e., MSDs or CMDs), 2) study design (prospective), 3) modifiable factors, 4) outcomes of interest (i.e., RTW). Studies showing high risk of bias were eliminated. Tools used to measure prognostic factors were assessed using psychometric and usability criteria. From the 78 studies that met inclusion criteria, 19 (for MSDs) and 5 (for CMDs) factors reaching moderate or strong evidence were extracted. These factors included work accommodations, RTW expectations, job demands (physical), job demands (psychological), job strain, work ability, RTW self-efficacy, expectations of recovery, locus of control, referred pain (back pain), activities as assessed with disability questionnaires, pain catastrophizing, coping strategies, fears, illness behaviours, mental vitality, a positive health change, sleep quality, and participation. Measurement tools ranged from single-item tools to multi-item standardized questionnaires or subscales. The former generally showed low psychometric properties but excellent usability, whereas the later showed good to excellent psychometric properties and variable usability. The rigorous approach to the selection of eligible studies allowed the identification of a relatively small set of prognostic factors, but with a higher level of certainty. For each factor, the present tool assessment allows an informed choice to balance psychometric and usability criteria.

Project description:BackgroundCommon 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.Method/designThis 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.DiscussionThis 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.Trial registrationClinicalTrials.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:BackgroundCommon mental disorders present the main reason for registered sick leave in Sweden today, and women are at a higher risk of such sick leave than men. The aim of this paper is to explore how employees on sick leave for common mental disorders experience interventions and rehabilitation activities during return-to-work, as well as to explore similarities and differences between the experiences of the interviewed women and men.Material and methodsA qualitative design was applied with semi-structured focus group interviews. Seven focus groups were conducted with a total of 28 participants (13 women and 15 men). The focus group discussions were audiotaped and transcribed verbatim, and data analyzed with conventional content analysis. Similarities and differences in the women's and men's experiences were written down in reflective notes during all steps of the analysis.ResultsThe results comprise of one main category, "To be met with respect and recognition", and subcategories at two levels. Both similarities and differences emerged in how women and men sick-listed because of common mental disorders experienced return-to-work interventions and rehabilitation activities. It was important for both women and men to be met with respect and recognition, which was essential to all forms of help that the participants discussed during the focus group interviews. Women expressed a need for home-related interventions, whereas men expressed a need for organizational interventions to counter feelings of resignation at work. Women could also more easily understand their mental health condition as compared with men.ConclusionA key implication of this study is that research on interventions and rehabilitation activities during return-to-work among employees on sick leave for common mental disorders should consider whether the findings are relevant equally to both women and men. Similarly, return-to-work professionals may need to consider possible differences among women and men on sick leave for common mental disorders, and to further customize offered interventions and rehabilitation activities. Doing so may help enhance the effectiveness of such interventions.

Dataset Information

Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial.

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