Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety

NCT ID: NCT04250571

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2021-07-31

Brief Summary

Employing imaginary pills could offer a new way of investigating underlying mechanisms of open label placebo (OLP) treatment by eliminating the physical treatment constituent (i.e., the pill itself). This can reveal the power of the purely psychological component of a placebo and gives insights into underlying mechanisms of placebo effects. The aim of the project is to assess possible effects of an imaginary pill in comparison to no treatment, and open label placebo treatment in subjects with test anxiety.

Interventions (seven to three weeks before the exam) will be held online using a video Chat application such as zoom (https://zoom.us/) or skype (https://www.skype.com/de/) or will take place at the division of Clinical Psychology and Psychotherapy, University of Basel (Missionsstrasse 62, 4055 Basel).

Conditions

Test Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

No treatment group

Participants will receive no pills and will be told that they are in the no treatment group

Group Type: EXPERIMENTAL

information about "No treatment group"

Intervention Type: OTHER

Participants will receive no pills and will be told that they are in the no treatment group

Imaginary pill (IP) group

Participants will be instructed to take an imagined pill. This instruction consists of a procedure including five steps (i.e., identifying the IP sensitive problem, building trust/belief/reality of the IP, constructing a personally meaningful IP, taking the IP, suggestions for self-administering the IP in real life, and building adherence)

Group Type: EXPERIMENTAL

imaginary pill technique

Intervention Type: OTHER

Participants will be instructed to take an imagined pill. This instruction consists of a procedure including five steps (i.e., identifying the IP sensitive problem, building trust/belief/reality of the IP, constructing a personally meaningful IP, taking the IP, suggestions for self-administering the IP in real life, and building adherence). Participants in this group receive daily e-mail reminders.

Open label placebo group

Participants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo")

Group Type: EXPERIMENTAL

open label placebo

Intervention Type: OTHER

Participants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo"), combined with the following scientific rationale: (a) deceptive as well as open label placebos have been found to be effective in relieving symptoms in a variety of clinical conditions namely anxiety, depression, chronic pain (the placebo effect is powerful), (b) classical conditioning are one of the possible mechanism of this effect (the body automatically responds), (c) positive expectations may help but are not necessary, (suspend disbelief), (d) compliance with these instructions are important for outcome (taking the pills faithfully is important).

Participants in this group receive daily e-mail reminders.

Interventions

information about "No treatment group"

Participants will receive no pills and will be told that they are in the no treatment group

Intervention Type: OTHER

imaginary pill technique

Participants will be instructed to take an imagined pill. This instruction consists of a procedure including five steps (i.e., identifying the IP sensitive problem, building trust/belief/reality of the IP, constructing a personally meaningful IP, taking the IP, suggestions for self-administering the IP in real life, and building adherence). Participants in this group receive daily e-mail reminders.

Intervention Type: OTHER

open label placebo

Participants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo"), combined with the following scientific rationale: (a) deceptive as well as open label placebos have been found to be effective in relieving symptoms in a variety of clinical conditions namely anxiety, depression, chronic pain (the placebo effect is powerful), (b) classical conditioning are one of the possible mechanism of this effect (the body automatically responds), (c) positive expectations may help but are not necessary, (suspend disbelief), (d) compliance with these instructions are important for outcome (taking the pills faithfully is important).

Participants in this group receive daily e-mail reminders.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having an exam at the end of the semester, that is still at least four weeks ahead
• Self-reported fear of the exam (i.e., not clinical)
• Healthy by self-report statement (i.e., no known current or chronic somatic diseases or psychiatric disorders)
• Willing to participate in study

Exclusion Criteria

• Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
• Current medications (psychoactive medication, narcotics, intake of analgesics)
• Any psychiatric disorders or being currently in psychological or psychiatric treatment
• Insufficient German language skills to understand the instructions
• Daily consumption of more than three alcoholic standard beverages (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
• Current or regular drug consumption
• Being a master student in Psychology
• Allergy of one of the ingredients of the placebo pills (P-Dragees blue Lichtenstein)
• Problems to swallow pills

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dr., Jens Gaab, Division of Clinical Psychology and Psychotherapy, University of Basel, Switzerland

UNKNOWN

Sponsor Role: collaborator

Emer. Prof. Dr., Irving Kirsch, Universities of Hull and Plymouth, United Kingdom, and University of Connecticut, USA

UNKNOWN

Sponsor Role: collaborator

Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark

UNKNOWN

Sponsor Role: collaborator

Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal

UNKNOWN

Sponsor Role: collaborator

Dr. phil., Cosima Locher, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Buergler, M. Sc.

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Psychology and Psychotherapy, University of Basel

Locations

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

Basel, , Switzerland

Countries

Switzerland

References

Buergler S, Sezer D, Bagge N, Kirsch I, Locher C, Carvalho C, Gaab J. Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms. Sci Rep. 2023 Feb 14;13(1):2624. doi: 10.1038/s41598-023-29624-7.

Reference Type: BACKGROUND

PMID: 36788309 (View on PubMed)

Other Identifiers

035-19-1; ex20Gaab

Identifier Type: -

Identifier Source: org_study_id