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The Influence of Doctor-patient Communication on Treatment Expectation, Placebo and Nocebo Response (SENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949816
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:
The purpose of this study is to determine whether a patient-centered compared to doctor-centered communication style of a physician influences the treatment expectation and the placebo and nocebo response in healthy individuals.

Condition or disease Intervention/treatment Phase
Healthy Participants Other: medical consultation: different doctor-patient-centered style of communication Other: information letter / no medical consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Influence of Doctor-patient Communication on Treatment Expectation, Placebo and Nocebo Response
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: patient-centered communication style
The patient-centered style is characterized by features such as empathetic communication, open questions, and uses an easily understandable language.
Other: medical consultation: different doctor-patient-centered style of communication
Different doctor-patient communication

Experimental: doctor-centered communication style
The doctor-centered style is defined by an authoritarian and goal-oriented communication. The doctor uses medical terms instead of lay language.
Other: medical consultation: different doctor-patient-centered style of communication
Different doctor-patient communication

Active Comparator: information letter
In the active control treatment participants receive all information about the herbal medical product in an information letter but have no contacted with the simulated doctor.
Other: information letter / no medical consultation
In the control treatment participants receive all information about the herbal medical product in an information letter but have no contacted with the simulated doctor.




Primary Outcome Measures :
  1. Change in treatment outcome expectations from baseline to post-intake [ Time Frame: Change in treatment outcome from baseline to post-intake (within 10 minutes after intake of first placebo pill) ]
    Visual analogue scale (VAS) measuring participant's treatment outcome expectations at baseline and at post-intake. Minimum VAS score: 0% - "the herbal medical product will not help me to reduce my stress symptoms", maximum VAS score: 100% - "the herbal medical product will help me to reduce my stress symptoms completely" (self-rating). A change score will be computed ("post-intake score" minus "baseline score"; Range of change score: -100 to +100). A higher score indicates a higher positive change in treatment outcome expectation from baseline to post-intake.


Secondary Outcome Measures :
  1. Change in treatment outcome expectations from baseline to post-consultation [ Time Frame: Change in treatment outcome from baseline to post-consultation (immediately after doctor-patient communication/information letter). ]
    Visual analogue scale (VAS) measuring participant's treatment outcome expectations at baseline and at post-consultation. Minimum VAS score: 0% - "the herbal medical product will not help me to reduce my stress symptoms", maximum VAS score: 100% - the herbal medical product will help me to reduce my stress symptoms completely" (self-rating). A change score will be computed ("post-consultation score" minus "baseline score"; Range of change score: -100 to +100). A higher score indicates a higher positive change in treatment outcome expectation from baseline to post-consultation.

  2. Change in treatment outcome expectations from baseline to 1-week follow-up [ Time Frame: Change in treatment Outcome from baseline to 1-week follow-up (after the one-week intake phase) ]
    Visual analogue scale (VAS) measuring participant's treatment outcome expectations at baseline and at 1-week follow-up. Minimum VAS score: 0% - "the herbal medical product will not help me to reduce my stress symptoms", maximum VAS score: 100% - the herbal medical product will help me to reduce my stress symptoms completely" (self-rating). A change score will be computed ("1-week follow-up score" minus "baseline score"; Range of change score: -100 to +100). A higher score indicates a higher positive change in treatment outcome expectation from baseline to 1-week follow-up.

  3. Perceived ease [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]

    VAS measuring perceived ease (operationalizes placebo effect). Minimum VAS score: 0% - no perceived ease, maximum VAS score: 100% - perceived absolute ease. A higher score indicates a higher perceived ease and operationalizes a higher placebo response (Score: 0% to 100%).

    VAS: "How calm inside do you feel at this moment?"


  4. Perceived inner tension [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]

    VAS measuring perceived inner tension (operationalizes placebo effect). Minimum VAS score: 0% - no perceived inner tension, maximum VAS score: 100% - perceived absolute inner tension. Inverted Item: A higher score indicates a higher perceived inner tension and operationalizes a lower placebo response (Score: 0% to 100%).

    VAS: "How tense do you feel inside at this moment?"


  5. Perceived mental exhaustion [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]

    VAS measuring perceived mental exhaustion (operationalizes placebo effect). Minimum VAS score: 0% - no perceived mental exhaustion, maximum VAS score: 100% - perceived absolute mental exhaustion. Inverted Item: A higher score indicates a higher perceived mental exhaustion and operationalizes a lower placebo response (Score: 0% to 100%).

    VAS: "How mentally exhausted do you feel at this moment?"


  6. Score of symptom severity [ Time Frame: post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]
    Generic Assessment of Side Effects (GASE): Score of symptom severity (operationalizes nocebo effect). Minimum sum score: 0 - no symptom severity, maximum sum score: 105 - maximal symptom severity. A higher sum score indicates a higher score of symptom severity (Score: 0 to 105).

  7. Number of symptoms which are attributed by participant for medication side effects [ Time Frame: post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]
    Generic Assessment of Side Effects (GASE): Number of symptoms which are attributed by participant for medication side effects (operationalizes nocebo effect). Minimum sum score: 0 - no symptoms, which are attributed for medication side effects, maximum sum score: 35 - maximal number of symptoms, which are attributed for medication side effects. A higher score indicates a higher Number of symptoms which are attributed by participant for medication side effects (Score: 0 to 35).

  8. Diastolic blood pressure [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]
    Diastolic blood pressure (measures by sphygmomanometer)

  9. Systolic blood pressure [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]
    Systolic blood pressure (measures by sphygmomanometer)

  10. Heart rate [ Time Frame: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase) ]
    Heart rate (measures by sphygmomanometer)

  11. number of pills that have not been taken and returned [ Time Frame: 1-week follow-up (after the one-week intake phase) ]
    number of pills that have not been taken and returned (operationalizes medication adherence)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • between 18 and 35 years
  • healthy
  • adequate ability to see
  • fluent in German (reading and writing)

Exclusion Criteria:

  • regular intake of medication that enhances relaxation
  • intake of psychotropic drugs
  • during the past 2 years in psychotherapeutic treatment for diagnosed mental disorder
  • current pregnancy or lactation
  • students enrolled in medicine, psychology or pharmacy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949816


Contacts
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Contact: Maria Kleinstaeuber, PhD +49 6421 28-23657 kleinsta@staff.Uni-Marburg.DE
Contact: Lena Sarter, M.Sc. +49 6421 28-23657 lena.sarter@staff.uni-marburg.de

Locations
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Germany
Philipps-University Marburg, Faculty psychology, department clinical psychology
Marburg, Hessen, Germany, 35032
Contact: Winfried Rief, PhD    +49 6421 28-23657    rief@staff.Uni-Marburg.DE   
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Study Chair: Winfried Rief, PhD Philipps-University Marburg, Faculty psychology, department clinical psychology
Publications:
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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03949816    
Other Study ID Numbers: 2019-20k
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipps University Marburg Medical Center:
patient-centered communication
doctor-centered communication
placebo
nocebo
outcome expectation
blood pressure
heart rate
patient-physician communication