Trial document




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  DRKS00017133

Trial Description

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Title

Assessment of treatment expectations within the interdisciplinary pain therapy - a culture sensitive translation and validation of the "credibility expectancy questionnaire"

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of our study is to translate the "credibility expectancy questionnaire (CEQ)" (Devilly & Bordovec, 2000) into German. The CEQ is a measure instrument developed and validated in the English language, which assesses the patient´s perceived credibility of a therapy program as well as the patient´s treatment expectation. After the translation of the questionnaire the goal of the study is to determine whether the CEQ actually measures what it is supposed to measure and whether it can be used within interdisciplinary pain therapy. Study participants are patients who suffer from chronic pain and are undergoing treatment in one of our two cooperating institutions (UniversitätsSchmerzCentrum Dresden, Rückenschmerz-Zentrum Essen).

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Brief Summary in Scientific Language

Ongoing research about interdisciplinary pain therapy addresses the following questions: 1) which factors influence the success of the therapy; and 2) which outcome-variables are significant in measuring treatment success (Deckert, Sabatowski, Schmitt & Kaiser, 2016). It is to be expected that the patient´s perceived credibility of a therapy program as well as the patient´s treatment expectations are important factors that influence the success of the aforementioned therapy. Several clinical studies measuring the efficiency of a treatment indicate that positive treatment expectations are associated with higher health-related outcome measures, although the effect sizes throughout the different studies vary significantly (e.g. Mondloch, Cole & Frank, 2001). The methods used for the assessment of therapy expectations are inconsistent throughout various studies, making the results difficult to compare (Bialosky, Bishop & Cleland, 2010). A questionnaire in the German language for assessing treatment expectations and the patient´s evaluation of a therapy already exists (PATHEV; Schulte, 2005). This instrument was developed for the use within psychotherapy treatments. Since interdisciplinary pain therapy also includes other treatments in addition to psychotherapy, there are limitations to the use of the PATHEV in this therapy program. Another difficulty regarding the use of this questionnaire is that it is only accessible in the German language and is therefore inapplicable for international studies. These problems should be addressed with this dissertation thesis. The aim of our study is to translate the "credibility expectancy questionnaire (CEQ)" (Devilly & Borkovec, 2000) into the German language, adapt it for the use within interdisciplinary pain therapy and conduct a validation study for the translated instrument. The CEQ was originally developed and validated in the English language. It is a questionnaire that assesses the credibility of a therapy program as well as the patient´s treatment expectations. Originally it was developed for the use in the field of trauma therapy within clinical studies. The goal of our study is to create a culture sensitive translation of the CEQ in the German language and adapt it for the use within interdisciplinary pain therapy. Afterwards we want to test the validity of the translated instrument. During the translation, adaptation and validation process, we will follow the suggested current guidelines (Sousa & Rojjanasrirat, 2011; Wild et al., 2005). This entails following a multi-step protocol with several phases of forward- and backward- translations resulting in a pre-final version of the translated instrument. This version will then be tested and further adapted within a pilot-study. In addition to this process we plan on interviewing patients from the target population using "focus-groups" (groups of up to 9 patients) to ensure the questionnaire items represent the underlying constructs. After pilot testing is complete, the final version of the translated and adapted instrument will be tested within a validity study.

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Organizational Data

  •   DRKS00017133
  •   2019/05/23
  •   [---]*
  •   yes
  •   Approved
  •   EK469122017, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   The translated version of the CEQ will be presented to the patients at two separate times during the study: t1) before the patients start the therapy program, but after they have been informed about the treatment concept by a nurse and/or an information flyer; t2) one week after the beginning of the treatment program. For the purpose of investigating the convergent, incremental and discriminant validity of the CEQ, the patients are also asked to fill out the existing German questionnaire assessing treatment expectations and therapy evaluation (PATHEV; Schulte, 2005) as well as a questionnaire measuring their overall expectation of self-efficacy (SWE, Schwarzer & Jerusalem, 1988) at both t1 and t2. In order to test the predictive validity of the CEQ, we chose selected outcome-variables that will be assessed with the help of the following questionnaires:
    - the German version of the "Pain catastrophizing scale" (Meyer, Sprott & Mannion, 2008)
    - the German version of the "Chronic Pain Acceptance Questionnaire (CPAQ-D)" (Nilges, Köster & Schmidt, 2007)
    - the "Pain Disability Index (PDI)" (Dillmann, Nilges, Saile & Gerbershagen, 1994)
    - the SF-12 as a short form of the SF-36 (Bullinger, 2000), whereby only the scale "overall perception of health" will be used.
    In order to assess the patient´s changes within these variables, the patients will be asked to fill out the mentioned questionnaires at t1, t3 (at the end of the therapy) and t4 (10 weeks after the end of the treatment). Furthermore, every patient will be asked to evaluate their treatment success on a 5-point rating scale (very good - bad) at t3 and t4 (Deutscher Schmerzfragebogen der DGSS, web-link: http://www.dgss.org/deutscher-Schmerzfragebogen/).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- translated version of the CEQ at t1 (before the patients start the therapy program) and t2 (one week after the beginning of the treatment program)

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Secondary Outcome

- questionnaire about treatment expectations and therapy evaluation (PATHEV; Schulte, 2005) at both t1 and t2
- questionnaire assessing their overall expectation of self-efficacy (SWE, Schwarzer & Jerusalem, 1988) at both t1 and t2
- the German version of the "Pain catastrophizing scale" (Meyer, Sprott & Mannion, 2008) at t1, t3 (the end of the therapy) and t4 (10 weeks after the end of the treatment)
- the German version of the "Chronic Pain Acceptance Questionnaire (CPAQ-D)" (Nilges, Köster & Schmidt, 2007) at t1, t3 and t4
- the "Pain Disability Index (PDI)" (Dillmann, Nilges, Saile & Gerbershagen, 1994) at t1, t3 and t4
- the SF-12 as a short form of the SF-36 (Bullinger, 2000), whereby only the scale "overall perception of health" will be used at t1, t3 and t4
- overall evaluation of treatment success on a 5-point rating scale (very good - bad) at t3 and t4 (Deutscher Schmerzfragebogen der DGSS, web-link: http://www.dgss.org/deutscher-Schmerzfragebogen/)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/01
  •   167
  •   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 who suffer from chronic, non-tumor-related pain and are taking part in an interdisciplinary pain therapy in one of two cooperating institutions (UniversitätsSchmerzCentrum Dresden, Rückenschmerz-Zentrum Essen) will be included in the study.

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Exclusion Criteria

Exclusion criteria are tumor-related pain, age under 18 years, a lack of a certain physical or psychological stability required for the treatment program (tested within medical, psychological and physiotherapeutic assessments), or severe psychiatric disorders.

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Addresses

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    • Universitätsklinikum Carl Gustav Carus, UniversitätsSchmerzCentrum (USC)
    • Mr.  Prof. Dr. med.  Rainer  Sabatowski 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Essen,Rückenschmerz-Zentrum
    • Ms.  Prof. Dr. med.  Ulrike  Bingel 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Carl Gustav Carus,UniversitätsSchmerzCentrum (USC)
    • Ms.  Dipl.- Psych.  Lisa  Taubert 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Carl Gustav Carus,UniversitätsSchmerzCentrum (USC)
    • Ms.  Dipl.-Psych.  Lisa  Taubert 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

  •   Ethikvotum- ethics vote
  •   Exposé
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