Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice (PATOLP)

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.

Study Overview

• Status: Recruiting
• Conditions: Open-label Placebos
• Intervention / Treatment: Other: focus group discussions (FGD)

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 Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Antje Frey Nascimento, Dr.; Phone Number: + 41 61 207 05 98; Email: antje.freynascimento@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • Recruiting
    • University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
    • Contact: Antje Frey Nascimento, Dr.; Phone Number: +41 61 207 05 98; Email: antje.freynascimento@unibas.ch
    • Principal Investigator: Antje Frey Nascimento, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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
  • 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease	Other: 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?
Chronic back pain	Other: 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?
Clinically significant menopausal complaints	Other: 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?
Migraine	Other: 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?
Cancer-related emesis/nausea	Other: 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one time assessment at baseline with a duration from max. 60 minutes.

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Antje Frey Nascimento, Dr., University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: focus group discussions (FGD)
• Other Study ID Numbers: 2021-02304; ex21Frey

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No