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

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2273-0) contains supplementary material, which is available to author...

Developing Normative Integration among Professionals in an Intersectoral Collaboration: A Multi-Method Investigation of an Integrated Intervention for People on Sick Leave Due to Common Mental Disorders

“…The intervention was delivered in two multicentre, randomized controlled trials with return to any work without receipt of sick leave benefit as the primary outcome, from May 2016 to November 2018 [2425]. Care managers provided therapy or stress coaching.…”

“…Mental health care centers have no direct responsibility to support return to work, and most care managers had no previous experience with work-oriented intervention or collaboration with the Jobcenters. Employment consultants provided vocational rehabilitation support based on problem-solving methods [242526] based on the Dutch ‘SHARP- at work’ intervention [2728], gradual return to work (which is the common method for return to work for employed persons in Denmark), and managed the sick leave case in accordance with Danish sick leave legislation. Administration of the public sickness benefit insurance case involves continuous monitoring of workability to decide eligibility for financial support [2930].…”

“…Relational coordination is developed through an iterative process where shared goals, shared knowledge , and mutual respect between functional groups lead to communication that is often, timely, accurate, understandable, and problem-solving , and vice versa [3334]. The creation of shared goals among professionals and participants was described as particularly important in the integrated IBBIS intervention and should be established through inter-disciplinary assessment of the participant in the context of a roundtable meeting [242526]. During the roundtable meeting, the IBBIS participant, the care manager, and the employment consultant should describe the goals and plans for the participant after each professional had made a mono-disciplinary assessment.…”

“…The roundtable meeting resulted in a written document, The joint plan , which described the mono-disciplinary and shared goals and plans [26]. See [242526] for an elaborate description of integration activities. The intervention manual was revised 11 months into the intervention delivery [26].…”

Assessing measurement equivalence of the Danish and Dutch Four-Dimensional Symptom Questionnaire using differential item and test functioning analysis

“…The Danish source population consisted of citizens on sick leave due to mental-health problems, who were assessed for the IBBIS study in Danish job centres in four municipalities in Denmark [16,17] and who had completed the Danish 4DSQ at baseline. The IBBIS study was approved by regional ethics committees of the capital region, and participants gave informed consent [16,17]. The first Dutch source population consisted of employees on sick leave for any reason [4].…”