NCT03046940

Brief Summary

The experiment aims at investigating whether the doctor-patient communication has an influence on patients' willingness to take medication. Patients' attitude towards the medication is manipulated via a critical film sequence. Afterwards patients of the two experimental groups have a communication with one of the investigators of the study. Patients are told that the investigator is a medical doctor. The "doctors" either communicate in a patient-centered or doctor-centered style with the patient. Patients in the control group do not have the possibility to talk to a "medical doctor". Afterwards patients are offered the aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill). Pill intake is voluntary. The investigators hypothesize that patients in the experimental group with the patient-centered style of communication are more likely to take the pill than patients in the experimental group with the doctor-centered style of communication or patients in the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

January 30, 2017

Last Update Submit

June 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pill intake

    Behavioural test

    Within 10 minutes after doctor-patient communication

Secondary Outcomes (3)

  • Willingness to take medication (VAS)

    Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication

  • Critical attitude towards the medication (VAS)

    Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication

  • Influence on concentration (Concentration task)

    Directly (within 10 minutes) after the pill was offered

Study Arms (3)

Control group

NO INTERVENTION

No communication with a doctor

Patient-centered

EXPERIMENTAL

Participants communicate with a doctor that uses a patient-centered style of communication

Other: Patient-centered style of communication

Doctor-centered

EXPERIMENTAL

Participants communicate with a doctor that uses a doctor-centered style of communication

Other: Doctor-centered style of communication

Interventions

Different doctor-patient communication

Patient-centered

Different doctor-patient communication

Doctor-centered

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 cognitive enhancers/medication that enhances concentration
  • intake of psychotropic drugs
  • medical or pharmacy students, advanced psychology students
  • participants who know the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Location

Study Officials

  • Winfried Rief, PhD, Prof

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 8, 2017

Study Start

March 15, 2017

Primary Completion

June 8, 2017

Study Completion

June 8, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations