Healthy ParticipantsSENSENCT03949816
The Influence of Doctor-patient Communication on Treatment Expectation, Placebo and Nocebo Response
A study testing medical consultation: different doctor-patient-centered style of communication and information letter / no medical consultation in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- medical consultation: different doctor-patient-centered style of communication and information letter / no medical consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- between 18 and 35 years
- healthy
- adequate ability to see
- fluent in German (reading and writing)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps-University Marburg, Faculty psychology, department clinical psychology
Marburg, Hesse, 35032
Winfried Rief, PhD, +49 6421 28-23657, rief@staff.Uni-Marburg.DE
About this study
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.
Read the detailed description
Doctor-patient communication is crucial for the success of treatment and patients´ quality of life. It could be shown that the medical communication style during the consultation has an effect on the treatment expectation and can therefore positively influence the effect of a sham treatment (placebo ointment). The doctor's communication style has already been successfully manipulated in experimental designs. However, the question remains to what extent the doctor's communication style is related to the placebo/nocebo response and the change in effect-related expectations after a one-week intake of a supposedly medical herbal product (drug-free placebo).
It is expected that the patient-centered communication style of the physician has a positive impact on the reduction of stress (placebo response) and the effect-related cognitive expectations. Furthermore, the physician-centered communication style is expected to negatively impact potential side effects (nocebo response) and impact-related expectations.
Participants will be recruited via posters on public notice boards and e-mail distribution lists. After individuals register for participating in the study, they are called by a study assistant. Eligibility criteria are checked and participants are asked questions about control variables (sociodemographic data (age, sex, profession) and symptom report (Generic Assessment of Side Effects GASE)). The subjects are told that an herbal medical product (drug-free placebo pill) is tested for the reduction of stress symptoms (cover story). Subjects are randomly assigned to 3 groups (2 experimental groups: patient-centered communication style, doctor-centered communication style, control treatment: information letter). Eligible participants come in the lab for an experimental appointment. They first complete a questionnaire at baseline assessment about control variables (further sociodemographic data, disability of stress symptoms, anxiety (trait), negative and positive affectivity, communication preferences, beliefs about medicines, adherence) and outcome variables (treatment expectation, placebo response, Nocebo response, blood pressure and heart rate).
Participants in the experimental groups are then informed by a simulated doctor (played by a study assistant) about indications and side effects of the herbal medical product. The doctor applies either a patient-centered or doctor-centered communication style. The patient-centered style is characterized by features such as empathetic communication, open questions, and uses an easily understandable language. The doctor-centered style is defined by an authoritarian and goal-oriented communication. The doctor uses medical terms instead of lay language. 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. Participating subjects, who receive a medical consultation, complete a brief questionnaire after doctor's consultation about the satisfaction with the consultation and the anticipated treatment expectancy (post-consultation). Then participants in all three groups are asked to take the herbal medical product (placebo pill). At the end of the experimental appointment, participants are asked to complete another questionnaire about the outcome variables (treatment expectation, placebo response, Nocebo response, blood pressure and heart rate) (post-intake). Participating subjects are instructed to take the placebo pill once a day over the next week. Seven days after the first appointment participants are invited to come to the lab for a follow-up assessment (1-week follow-up).
The treatment expectancy is operationalized with visual analogue scale about participant's treatment outcome expectations (VAS, see primary outcomes) at post-intake and 1-week follow-up. The placebo effect is operationalized with visual analogue scale about the relaxation level (VAS, see secondary outcomes) at post-intake and 1-week follow-up.
The nocebo effect is operationalized with the number of symptoms and symptom severity (Generic Assessment of Side Effects GASE, see secondary outcomes) attributed by participants to a medication side effect at post-intake and 1-week follow-up.
- Conditions
- Healthy Participants
- Being tested
- medical consultation: different doctor-patient-centered style of communication, information letter / no medical consultation
- Keywords
- patient-centered communication, doctor-centered communication, placebo, nocebo, outcome expectation, blood pressure, heart rate, patient-physician communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical consultation: different doctor-patient-centered style of communicationOther
Different doctor-patient communication
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: information letter / no medical consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Change in treatment Outcome from baseline to 1-week follow-up (after the one-week intake phase)
Perceived ease
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?"
Measured: 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
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?"
Measured: 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
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?"
Measured: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)
Score of symptom severity
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).
Measured: post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)
Number of symptoms which are attributed by participant for medication side effects
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).
Measured: post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)
Diastolic blood pressure
Diastolic blood pressure (measures by sphygmomanometer)
Measured: 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
Systolic blood pressure (measures by sphygmomanometer)
Measured: 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
Heart rate (measures by sphygmomanometer)
Measured: baseline assessment, post-intake (within 10 minutes after intake of first placebo pill), 1-week follow-up (after the one-week intake phase)
number of pills that have not been taken and returned
number of pills that have not been taken and returned (operationalizes medication adherence)
Measured: 1-week follow-up (after the one-week intake phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start20 May 2019 (estimated)
- Primary completion20 Oct 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, PhD, Study chair, Philipps-University Marburg, Faculty psychology, department clinical psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949816
- Sponsor's protocol ID
- 2019-20k
- Acronym
- SENSE
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20638817Czerniak 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.
PubMed 27445878Epstein 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.
PubMed 20679652Graugaard 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.
PubMed 10705909Howe 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.
PubMed 28277699
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Doctor-patient Communication on Treatment Expectation, Placebo and Nocebo Response
- ClinicalTrials.gov ID
- NCT03949816
- Acronym / sponsor ID
- SENSE / 2019-20k
- Conditions
- Healthy Participants
- Keywords
- patient-centered communication, doctor-centered communication, placebo, nocebo, outcome expectation, blood pressure, heart rate, patient-physician communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 20 May 2019 (estimated)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Doctor-patient communication is crucial for the success of treatment and patients´ quality of life. It could be shown that the medical communication style during the consultation has an effect on the treatment expectation and can therefore positively influence the effect of a sham treatment (placebo ointment). The doctor's communication style has already been successfully manipulated in experimental designs. However, the question remains to what extent the doctor's communication style is related to the placebo/nocebo response and the change in effect-related expectations after a one-week intake of a supposedly medical herbal product (drug-free placebo).
It is expected that the patient-centered communication style of the physician has a positive impact on the reduction of stress (placebo response) and the effect-related cognitive expectations. Furthermore, the physician-centered communication style is expected to negatively impact potential side effects (nocebo response) and impact-related expectations.
Participants will be recruited via posters on public notice boards and e-mail distribution lists. After individuals register for participating in the study, they are called by a study assistant. Eligibility criteria are checked and participants are asked questions about control variables (sociodemographic data (age, sex, profession) and symptom report (Generic Assessment of Side Effects GASE)). The subjects are told that an herbal medical product (drug-free placebo pill) is tested for the reduction of stress symptoms (cover story). Subjects are randomly assigned to 3 groups (2 experimental groups: patient-centered communication style, doctor-centered communication style, control treatment: information letter). Eligible participants come in the lab for an experimental appointment. They first complete a questionnaire at baseline assessment about control variables (further sociodemographic data, disability of stress symptoms, anxiety (trait), negative and positive affectivity, communication preferences, beliefs about medicines, adherence) and outcome variables (treatment expectation, placebo response, Nocebo response, blood pressure and heart rate).
Participants in the experimental groups are then informed by a simulated doctor (played by a study assistant) about indications and side effects of the herbal medical product. The doctor applies either a patient-centered or doctor-centered communication style. The patient-centered style is characterized by features such as empathetic communication, open questions, and uses an easily understandable language. The doctor-centered style is defined by an authoritarian and goal-oriented communication. The doctor uses medical terms instead of lay language. 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. Participating subjects, who receive a medical consultation, complete a brief questionnaire after doctor's consultation about the satisfaction with the consultation and the anticipated treatment expectancy (post-consultation). Then participants in all three groups are asked to take the herbal medical product (placebo pill). At the end of the experimental appointment, participants are asked to complete another questionnaire about the outcome variables (treatment expectation, placebo response, Nocebo response, blood pressure and heart rate) (post-intake). Participating subjects are instructed to take the placebo pill once a day over the next week. Seven days after the first appointment participants are invited to come to the lab for a follow-up assessment (1-week follow-up).
The treatment expectancy is operationalized with visual analogue scale about participant's treatment outcome expectations (VAS, see primary outcomes) at post-intake and 1-week follow-up. The placebo effect is operationalized with visual analogue scale about the relaxation level (VAS, see secondary outcomes) at post-intake and 1-week follow-up.
The nocebo effect is operationalized with the number of symptoms and symptom severity (Generic Assessment of Side Effects GASE, see secondary outcomes) attributed by participants to a medication side effect at post-intake and 1-week follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient-centered communication style | Experimental | Other: medical consultation: different doctor-patient-centered style of communicationThe patient-centered style is characterized by features such as empathetic communication, open questions, and uses an easily understandable language. |
| doctor-centered communication style | Experimental | Other: medical consultation: different doctor-patient-centered style of communicationThe doctor-centered style is defined by an authoritarian and goal-oriented communication. The doctor uses medical terms instead of lay language. |
| information letter | Active comparator | Other: information letter / no medical consultationIn 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female
- between 18 and 35 years
- healthy
- adequate ability to see
- fluent in German (reading and writing)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical consultation: different doctor-patient-centered style of communicationDifferent doctor-patient communication | Other | doctor-centered communication style, patient-centered communication style |
| information letter / no medical consultationIn the 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 |
Primary outcome
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.
11 secondary outcomes
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)
number of pills that have not been taken and returned
Time frame: 1-week follow-up (after the one-week intake phase)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Background: PubMed 20638817Bensing 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.
- Background: PubMed 27445878Czerniak 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.
- Background: PubMed 20679652Epstein 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.
- Background: PubMed 10705909Graugaard 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.
- Background: PubMed 28277699Howe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, PhD study chair
Philipps-University Marburg, Faculty psychology, department clinical psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical consultation: different doctor-patient-centered style of communication and information letter / no medical consultation in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Kleinstaeuber, PhD (+49 6421 28-23657, kleinsta@staff.Uni-Marburg.DE), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.