Trial document




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  DRKS00023175

Trial Description

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Title

Work-related medical rehabilitation in patients with mental disorders

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Trial Acronym

WMR-P

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URL of the Trial

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Brief Summary in Lay Language

Work-related medical rehabilitation is aimed at people who have a high risk of not being able to return to work after rehabilitation. Additional work-related rehabilitation modules are intended to improve these people's work ability and their work participation. There is evidence for the effectiveness of work-related medical rehabilitation, in particular in patients with musculoskeletal disorders. For patients with mental disorders strong evidence for the effectiveness of work-related medical rehabilitation is still lacking. The study therefore aims to analyze the effects of work-related medical rehabilitation in comparison to conventional psychosomatic rehabilitation.

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Brief Summary in Scientific Language

Sickness absence, health-related early retirement and recognized severe disabilities due to mental disorders have increased significantly in recent years. Various rehabilitation services and return-to-work programs have been developed in order to reduce sickness absence and increase sustainable return-to-work. For people with a high risk of not returning to work the model of work-related medical rehabilitation (WMR) was developed in Germany. For the implementation of such programs, the pension insurance institutions have drawn up joint recommendations concerning target group, content and extent. These recommendations were summarized in WMR guidelines. Up to now there is evidence for the effectiveness of WMR, particularly in patients with musculoskeletal disorders. In psychosomatic rehabilitation, randomized controlled trials have also shown more favorable work participation outcomes in favor of additional work-related interventions. These studies, however, tested a very specific rehabilitation approach that combined external work exposure with accompanying therapeutic groups. However, there is no clear evidence of the effectiveness of WMR implemented in real-life care based on the WMR guidelines of the German Pension Insurance. The study therefore analyses the effects of WMR in psychosomatic rehabilitation under conditions of daily routine. Our randomized controlled trial will be conducted in six rehabilitation centers across Germany. Focus groups and individual interviews supplement our study with qualitative data.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The primary data cannot be shared as the data protection concept of the study and the patient consent forms do not cover this.

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Organizational Data

  •   DRKS00023175
  •   2020/09/29
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  •   no
  •   Approved
  •   18-141, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1194-2861 
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Health Condition or Problem studied

  •   F00-F99 -  Mental and behavioural disorders
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Interventions/Observational Groups

  •   People in study arm 1 (intervention condition) will receive a work-related medical rehabilitation (WMR). WMR contains work-related diagnostics, intensified social counseling, work-related psychosocial groups and work-related functional capacity training. Goals and contents as well as frequency and duration of these components are described in the guideline for WMR (Federal German Pension Insurance 2019). The actual design of the measures depends on the rehabilitation centers.

    Work-related diagnostics: Work-related assessments are performed to plan and design therapeutic interventions individually. Diagnostic measures are also needed to develop recommendations for adapting the patient’s job environment. Work-related assessments determine individual rehabilitation needs by comparing work-related physical and psychosocial functional capacity with the patient’s job demands. Assessment of functional capacity and job demands is performed by interviews, tests and questionnaires. The rehabilitation team uses standardized profiling to contrast individual capacities and job demands. The comparison of individual capacities and job demands reveals discrepancies in demands and capacities due to excessive demands and/or insufficient capacities. Therapists of different occupational backgrounds are involved, particularly physicians, psychologists, occupational therapists, exercise therapists and social workers. Diagnostic measures are performed face-to-face and individually. The intervention is performed at the beginning and, if necessary, also during or at the end of the rehabilitation program for a total of at least 90 minutes.

    Social counseling: The aims of social counseling in WMR are providing information about the various possibilities for supporting work participation and working out solutions for individual occupational and social problems. Social counseling examines the individual work-life situation and provides socio-legal guidance and advice concerning further assistance within the social security system. The intervention usually takes place in the course of several counseling sessions. In the group session, presentation slides are used to illustrate possibilities available in the social security system. After individual consultation appointments, patients receive written summaries of the discussed contents. Social counseling is provided by social workers. The intervention consists of face-to-face individual sessions and an additional group intervention with a maximum of 15 participants. Social counseling in the context of WMR is provided at least twice, which amounts to at least 30 minutes.

    Work-related psychosocial groups: The aim of work-related psychosocial groups is to learn how to deal with work-related conflicts. The group discusses conflicts and interactional problems but also resources and skills that can be used in the workplace. The participants are taught knowledge about triggers. The exchange within the group enables the participants to work out strategies for coping with conflicts together. Additionally, preventive measures to avoid stress and conflicts are taught. Both psychoanalytical and behavioral therapy approaches are used. Psychosocial sessions are performed by clinical psychiatrists or psychological therapists. Work-related psychosocial groups are conducted face-to-face in groups of a maximum of 15 people. Sessions are scheduled four to ten times during a WMR program. Each session lasts at least 45 minutes, which corresponds to a minimum therapy dose of 180 minutes.

    Work-related functional capacity training: The aim of work-related functional capacity training is to increase the capacity to cope job demands. In work-related functional capacity training, complex work routines relevant to the workplace are trained (e.g. group project work to explore interactive behavior). The intervention is primarily carried out by occupational therapists. In addition, parts of the training are carried out by physiotherapists, vocational trainers, psychologists and psychotherapists. Work-related functional capacity training is performed face-to-face as a group intervention with a maximum of 15 participants. The work-related functional capacity training takes place at least six times, amounting to at least 360 minutes.

    All treatment components are delivered in inpatient rehabilitation facilities. Lecture halls with screens for the lectures and the presentation of slides are available. Individual discussions take place in therapy rooms. Group therapy rooms are available for group therapy. Occupational therapy facilities are available and contain all the materials needed for the work-related functional capacity training. All treatment components will be documented in the standardized rehabilitation discharge letters to assess the actual delivered dose. The rehabilitation teams use the corresponding codes of the classification of therapeutic interventions developed by the German Pension Insurance for quality assurance in rehabilitation. In addition, patients will be asked about content and achievement of therapy goals at the end of the rehabilitation program with a standardized set of questions.

  •   People in study arm 2 (control condition) receive a conventional psychosomatic rehabilitation according to the guideline for psychosomatic rehabilitation of the German Pension Insurance.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome of this study is stable return to work 12 months after rehabilitation (at least four weeks employed without sick leave). Return to work will also be assessed three months after rehabilitation.

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Secondary Outcome

Follow-up data will be assessed at the end of the rehabilitation and three and 12 months after completing the rehabilitation program by questionnaires. We assess days of sick leave after discharge from rehabilitation, current sick leave, employment status, self-reported work ability (Tuomi 1991), health-related quality of life (Morfeld et al. 2011), psychosocial health (Rabung et al. 2014), job-related anxieties (Linden et al. 2008), regeneration and resistance beliefs (Otto and Linden 2017), the received dose of work-related treatment components, treatment satisfaction (Schmidt 1989), and use of medical and non-medical health care services (Seidl et al. 2015).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/10/08
  •   1800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Patients with mental disorders with a need for WMR will be included. The need for WMR will be determined by the participating rehabilitation centers using a standardized screening (SIMBO-C) (Streibelt und Bethge 2019).

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Exclusion Criteria

None

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Addresses

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    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10709  Berlin
    • Germany
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    • Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Hochschule Nordhausen Institut für Sozialmedizin, Rehabilitationswissenschaften und Versorgungsforschung
    • Mr.  Prof. Dr.  Markus  Bassler 
    • Weinberghof 4
    • 99734  Nordhausen
    • Germany
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    • Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie
    • Ms.  Miriam  Markus 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Hochschule Nordhausen Institut für Sozialmedizin, Rehabilitationswissenschaften und Versorgungsforschung
    • Ms.  Nina  Gabriel 
    • Weinberghof 4
    • 99734  Nordhausen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10709  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.