Completed

NCT Number: NCT05166213

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

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.

Completed

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Key information

Conditions

Open-label Placebos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy

Basel, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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?

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland