NCT03949816

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

May 6, 2019

Last Update Submit

May 11, 2019

Conditions

Healthy Participants

Keywords

patient-centered communicationdoctor-centered communicationplacebonocebooutcome expectationblood pressureheart ratepatient-physician communication

Outcome Measures

Primary Outcomes (1)

  • Change in treatment outcome expectations from baseline to post-intake

    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.

    Change in treatment outcome from baseline to post-intake (within 10 minutes after intake of first placebo pill)

Secondary Outcomes (11)

  • Change in treatment outcome expectations from baseline to post-consultation

    Change in treatment outcome from baseline to post-consultation (immediately after doctor-patient communication/information letter).

  • Change in treatment outcome expectations from baseline to 1-week follow-up

    Change in treatment Outcome from baseline to 1-week follow-up (after the one-week intake phase)

  • Perceived ease

    baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)

  • Perceived inner tension

    baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)

  • Perceived mental exhaustion

    baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)

  • +6 more secondary outcomes

Study Arms (3)

patient-centered communication style

EXPERIMENTAL

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

doctor-centered communication style

EXPERIMENTAL

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

information letter

ACTIVE COMPARATOR

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

Interventions

medical consultation: different doctor-patient-centered style of communicationOTHER

Different doctor-patient communication

doctor-centered communication stylepatient-centered communication style
information letter / no medical consultationOTHER

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.

information letter

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps-University Marburg, Faculty psychology, department clinical psychology

Marburg, Hesse, 35032, Germany

Location

Related Publications (5)

  • Bensing JM, Verheul W. The silent healer: the role of communication in placebo effects. Patient Educ Couns. 2010 Sep;80(3):293-9. doi: 10.1016/j.pec.2010.05.033. Epub 2010 Jul 17.

    PMID: 20638817BACKGROUND

  • Czerniak E, Biegon A, Ziv A, Karnieli-Miller O, Weiser M, Alon U, Citron A. Manipulating the Placebo Response in Experimental Pain by Altering Doctor's Performance Style. Front Psychol. 2016 Jun 30;7:874. doi: 10.3389/fpsyg.2016.00874. eCollection 2016.

    PMID: 27445878BACKGROUND

  • Epstein RM, Fiscella K, Lesser CS, Stange KC. Why the nation needs a policy push on patient-centered health care. Health Aff (Millwood). 2010 Aug;29(8):1489-95. doi: 10.1377/hlthaff.2009.0888.

    PMID: 20679652BACKGROUND

  • Graugaard PK, Finset A. Trait anxiety and reactions to patient-centered and doctor-centered styles of communication: an experimental study. Psychosom Med. 2000 Jan-Feb;62(1):33-9. doi: 10.1097/00006842-200001000-00005.

    PMID: 10705909BACKGROUND

  • Howe LC, Goyer JP, Crum AJ. Harnessing the placebo effect: Exploring the influence of physician characteristics on placebo response. Health Psychol. 2017 Nov;36(11):1074-1082. doi: 10.1037/hea0000499. Epub 2017 Mar 9.

    PMID: 28277699BACKGROUND

Study Officials

  • Winfried Rief, PhD

    Philipps-University Marburg, Faculty psychology, department clinical psychology

    STUDY CHAIR

Central Study Contacts

Maria Kleinstaeuber, PhD

CONTACT

+49 6421 28-23657kleinsta@staff.Uni-Marburg.DE

Lena Sarter, M.Sc.

CONTACT

+49 6421 28-23657lena.sarter@staff.uni-marburg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 14, 2019

Study Start

May 20, 2019

Primary Completion

October 20, 2019

Study Completion

November 1, 2019

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations

DE(1)