Open-label PlacebosPATOLPNCT05166213
Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice
An observational study of Open-label Placebos, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-label Placebos
- What is being tested?
- focus group discussions (FGD)
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Dec 2021to 10 Nov 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited with help of physicians from the following clinics: University Hospital Basel Anästhesiologie: Schmerzmedizin Frauenklinik: Gynäkologische Sozialmedizin und Psychosomatik Neurologie: Migräne und Morbus Parkinson Sprechstunden Onkologie und Psychoonkologie Privatklinik Hohenegg AG. Interested patients will receive a flyer of the study and will be asked if they prefer to enter in contact with the study team by themselves or if the study team is allowed to call the patient.
Who may be able to join
- Signed informed Consent form (see Appendix)
- Capable of consent (language/cognitive)
- At least 18 years of age
- Ability to attend an online conference in regard of physical and psychological condition and technical knowhow and equipment
- In addition, participants have to be affected by one of the following conditions/disorders:
- Chronic back pain
Show all 10Show fewer
- Chemotherapy-induced emesis (last occurrence at least before 14 days and at maximum before one year)
- Chronic migraine
- Parkinson's disease
- Clinically significant menopausal complaints
Who cannot join
- Severe ailment and medication side-effects which would interfere with study participation (e.g., due to concentration impairment)
- Acute psychological crisis which would affect study participation essentially or suicidality
- Co-morbidity that overlaps in symptoms with the symptoms necessary for inclusion
- Essential psychiatric disorders other than moderate depression
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Basel, 4055
About this study
The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted.
Read the detailed description
Substantial placebo effects have been known for several decades for a multitude of physical as well as psychological complaints. It is essential to test the acceptability of Open-label placebos (OLPs) of patients and health professionals. The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted. A semi-structured topic guide with open-ended questions will be used.
- Conditions
- Open-label Placebos
- Being tested
- focus group discussions (FGD)
- Keywords
- focus group discussions (FGD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus group discussions (FGD)Other
FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view?
| Study group | Role | What they receive |
|---|---|---|
| Chronic back pain | Not described Receives: Other: focus group discussions (FGD) | |
| Clinically significant menopausal complaints | Not described Receives: Other: focus group discussions (FGD) | |
| Parkinson's disease | Not described Receives: Other: focus group discussions (FGD) | |
| Migraine | Not described Receives: Other: focus group discussions (FGD) | |
| Cancer-related emesis/nausea | Not described Receives: Other: focus group discussions (FGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data analysis
Qualitative data analysis using the approach of "Thematic Analysis". This approach helps to identify, analyze, and interpret patterns of meanings in the form of upcoming "themes" in the qualitative data. Important "themes" deriving from the group discussion between the respective patient groups are explored. . In this manner, important subjective factors of OLP acceptance or non-acceptance can be revealed as well as boundaries of differences within opinions.
Measured: one time assessment at baseline with a duration from max. 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start16 Dec 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open-label PlacebosStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antje Frey Nascimento, Dr., Principal investigator, University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166213
- Sponsor's protocol ID
- 2021-02304; ex21Frey
- Acronym
- PATOLP
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frey Nascimento A, Bakis B, Gaab J, Schneider T, Papadopoulou A, Ritter M, Bernstein MH, Blease CR, Locher C. Talking placebo: a qualitative study of patients' attitudes toward open-label placebo implementation into clinical practice. Front Psychol. 2025 Jul 31;16:1533663. doi: 10.3389/fpsyg.2025.1533663. eCollection 2025.
PubMed 40823423
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice
- ClinicalTrials.gov ID
- NCT05166213
- Acronym / sponsor ID
- PATOLP / 2021-02304; ex21Frey
- Conditions
- Open-label Placebos
- Keywords
- focus group discussions (FGD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 21 Dec 2021 (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 aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted.
Detailed description
Substantial placebo effects have been known for several decades for a multitude of physical as well as psychological complaints. It is essential to test the acceptability of Open-label placebos (OLPs) of patients and health professionals. The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted. A semi-structured topic guide with open-ended questions will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chronic back pain | – | Other: focus group discussions (FGD) |
| Clinically significant menopausal complaints | – | Other: focus group discussions (FGD) |
| Parkinson's disease | – | Other: focus group discussions (FGD) |
| Migraine | – | Other: focus group discussions (FGD) |
| Cancer-related emesis/nausea | – | Other: focus group discussions (FGD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited with help of physicians from the following clinics: University Hospital Basel Anästhesiologie: Schmerzmedizin Frauenklinik: Gynäkologische Sozialmedizin und Psychosomatik Neurologie: Migräne und Morbus Parkinson Sprechstunden Onkologie und Psychoonkologie Privatklinik Hohenegg AG. Interested patients will receive a flyer of the study and will be asked if they prefer to enter in contact with the study team by themselves or if the study team is allowed to call the patient.
Key inclusion criteria (10 listed)
- Signed informed Consent form (see Appendix)
- Capable of consent (language/cognitive)
- At least 18 years of age
- Ability to attend an online conference in regard of physical and psychological condition and technical knowhow and equipment
- In addition, participants have to be affected by one of the following conditions/disorders:
Key exclusion criteria (4 listed)
- Severe ailment and medication side-effects which would interfere with study participation (e.g., due to concentration impairment)
- Acute psychological crisis which would affect study participation essentially or suicidality
- Co-morbidity that overlaps in symptoms with the symptoms necessary for inclusion
- Essential psychiatric disorders other than moderate depression
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 |
|---|---|---|
| focus group discussions (FGD)FGD to explore patients' attitudes/ concerns towards OLP implementation into clinical practice by means of assessment of qualitative information: 1) Patients' attitudes towards clinical usage of OLPs 2) Personal acceptance of OLP intervention 3) Perceived ideas, concerns regarding OLP implementation. Core questions: 1) Attitudes: After all that I told you about placebos, i.e. that there is a concept that patients are openly elucidated that they receive placebos: What does this elicit in you/What is your opinion on this? How do you like the idea? 2) Context of Acceptance: Under which conditions would you personally take placebos knowing that they are placebos? 3) Concerns: Why would you not take openly administered placebos? 4) Ideas for clinical implication: How could an open placebo intervention look like in the hospital? Where could it be possible to receive placebos and how could a placebo intervention in the best manner take place? What would be important from your point of view? | Other | Cancer-related emesis/nausea, Chronic back pain, Clinically significant menopausal complaints, Migraine, Parkinson's disease |
Primary outcome
Qualitative data analysis
Time frame: one time assessment at baseline with a duration from max. 60 minutes.
Qualitative data analysis using the approach of "Thematic Analysis". This approach helps to identify, analyze, and interpret patterns of meanings in the form of upcoming "themes" in the qualitative data. Important "themes" deriving from the group discussion between the respective patient groups are explored. . In this manner, important subjective factors of OLP acceptance or non-acceptance can be revealed as well as boundaries of differences within opinions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 40823423Frey Nascimento A, Bakis B, Gaab J, Schneider T, Papadopoulou A, Ritter M, Bernstein MH, Blease CR, Locher C. Talking placebo: a qualitative study of patients' attitudes toward open-label placebo implementation into clinical practice. Front Psychol. 2025 Jul 31;16:1533663. doi: 10.3389/fpsyg.2025.1533663. eCollection 2025.
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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.
Antje Frey Nascimento, Dr. principal investigator
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-label Placebos, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 17 Dec 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative data analysis (time frame: one time assessment at baseline with a duration from max. 60 minutes.). 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 NCT05166213, which also lists 1 linked publication.
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 17 Dec 2024.