Trial document





This trial has been registered retrospectively.
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  DRKS00003184

Trial Description

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Title

The “Psychosomatic Consultation in the Workplace” – a new model of care at the interface of company-supported mental health care and consultation-liaison psychosomatics

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Trial Acronym

PSIB

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Background: Mental health issues are gaining in importance in the society and economic system. Therefore, new models of care are being established at the interface of company-supported mental health care and conventional outpatient care for people developing mental illnesses. Two large companies (Daimler AG, location Sindelfingen and Untertürkheim, and CASSIDIAN, location Ulm) in cooperation with the local psychosomatic clinics have established the “psychosomatic consultation at the workplace“ in the shape of a consultation liaison model. Our main study goals are: Are there any differences and what are these differences in demographic characteristics, clinical and psychometric factors between patients who use the new offer vs. patients who use the conventional outpatient clinics? Do patients ultimately benefit from the new model of care? How effective do the physicians rate this offer? Where do the physicians see a need for change?
Methods: The study takes place in Ulm and in Stuttgart with each site utilizing one outpatient clinic and one company-supported mental health care model (n=280). We use well-established survey instruments (PHQ-SADS, SF-12, WAI, MBI, IS) as well as standardized questions about length of symptoms, number of times the patient / subject has received any mental heath / psychotherapeutic care, among others. For the quantitative data analyses, we use uni- and multivariate analytical methods. The qualitative data analysis (expert interviews) will be done using Mayring’s content analysis method. Discussion: With the new model yielding easy access for the affected, we are expecting to reach affected patients a lot earlier than with the conventional outpatient model. Based on our results, we seek to optimize the concept of the ”psychosomatic consultation at the workplace.“ Once we obtain initial results of the explorative study, we plan to further examine this new model of care and its effectiveness in a long-term clinical trial (RCT).

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Brief Summary in Scientific Language

Background: Mental health issues are gaining in importance in the society and economic system. Therefore, new models of care are being established at the interface of company-supported mental health care and conventional outpatient care for people developing mental illnesses. Two large companies (Daimler AG, location Sindelfingen and Untertürkheim, and CASSIDIAN, location Ulm) in cooperation with the local psychosomatic clinics have established the “psychosomatic consultation at the workplace“ in the shape of a consultation liaison model. Our main study goals are: Are there any differences and what are these differences in demographic characteristics, clinical and psychometric factors between patients who use the new offer vs. patients who use the conventional outpatient clinics? Do patients ultimately benefit from the new model of care? How effective do the physicians rate this offer? Where do the physicians see a need for change? Methods: The study takes place in Ulm and in Stuttgart with each site utilizing one outpatient clinic and one company-supported mental health care model (n=280). We use well-established survey instruments (PHQ-SADS, SF-12, WAI, MBI, IS) as well as standardized questions about length of symptoms, number of times the patient / subject has received any mental heath / psychotherapeutic care, among others. For the quantitative data analyses, we use uni- and multivariate analytical methods. The qualitative data analysis (expert interviews) will be done using Mayring’s content analysis method. Discussion: With the new model yielding easy access for the affected, we are expecting to reach affected patients a lot earlier than with the conventional outpatient model. Based on our results, we seek to optimize the concept of the ”psychosomatic consultation at the workplace.“ Once we obtain initial results of the explorative study, we plan to further examine this new model of care and its effectiveness in a long-term clinical trial (RCT).

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Organizational Data

  •   DRKS00003184
  •   2012/01/13
  •   [---]*
  •   yes
  •   Approved
  •   224/11, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1126-7485 
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Health Condition or Problem studied

  •   Depression (ICD-10 F30 ff), Anxiety (ICD-10 F40 ff), Somatisation (ICD-10 F45 ff), Burnout Syndrom (ICD-10 Z73)
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F45 -  Somatoform disorders
  •   Z73 -  Problems related to life-management difficulty
  •   F34 -  Persistent mood [affective] disorders
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F43 -  Reaction to severe stress, and adjustment disorders
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Interventions/Observational Groups

  •   Three large companies (2 of them metal-working, 1 security systems) in cooperation with the local psychosomatic clinics have established the “psychosomatic consultation at the workplace“ in the shape of a consultation liaison model.
  •   Patients making use of the outpatients psychosomatic-psychotherapeutic Health Care offered by the cooperating psychosomatic clinic at each site (Ulm and Stuttgart)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Work ability (WAI) (research questoin 2)
Identifying different types of patients with specific trait combinations while controlling for the setting (outpatient clinic vs. workplace). (research question 1, cross-sectional part of the study)

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Secondary Outcome

Quality of life (SF-12), clinical symptoms: depression (PHQ-9), somatoform symptom severity (PHQ-15), anxiety (PHQ-7), work related stress (irritationscale, maslach burnout inventory).
Identifying changes in disease severity, quality of life and ability to work 12 weeks after fist contact,
Measure for the extent to which recommendations have been implemented,
Patient satisfaction,
Exploration of the feedback received from the company staff (qualitative).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2011/11/01
  •   280
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients utilising the offer within the course of recruitment

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Exclusion Criteria

Age < 18 years, no employment (exclusion before data analysis)

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Addresses

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Sources of Monetary or Material Support

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    • Abt. Allgemeinmedizin und Versorgungsforschung Koordinierungsstelle Nachwuchsprogramm Netzwerk 'Versorgungsforschung Baden-Württemberg' (gefördert durch das Ministerium für Wissenschaft, Forschung und Kunst in Zusammenarbeit mit dem Ministerium für Arbeit und Sozialordnung, Familie, Frauen und Senioren)
    • Mr.  PD Dr.  Gunter  Laux 
    • Voßstr. 2
    • 69115  Heidelberg
    • Germany
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    • Ltd. Arzt des Betriebsmedizinischen Dienstes Firma CASSIDIAN
    • Mr.  Dr. med.  Marc  Krüger 
    • Landshuterstr. 26
    • 85716  Unterschleissheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/10/31
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Trial Publications, Results and other Documents

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