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

Completed

• Conditions: Open-label Placebos
• Interventions: Other: focus group discussions (FGD)

• Registration Number: NCT05166213
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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. 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 Timeline

• Study Start: 2021-12-16
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-21
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine	focus group discussions (FGD)	-
Chronic back pain	focus group discussions (FGD)	-
Clinically significant menopausal complaints	focus group discussions (FGD)	-
Cancer-related emesis/nausea	focus group discussions (FGD)	-
Parkinson's disease	focus group discussions (FGD)	-

Primary Outcome Measures

Name	Time	Method
Qualitative data analysis	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.

Trial Locations

Locations (1)

University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy; 🇨🇭 Basel, Switzerland