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

NCT04250571 | Completed

• 1 other identifier: 035-19-1; ex20Gaab
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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

Keywords

imaginary pills; open label placebo (OLP) treatment; placebo

Outcome Measures

Primary Outcomes (1)

• Change in Prüfungsangstfragebogen (PAF) questionnaire

  The PAF questionnaire consisting of 20 items with four subscales (worry, emotionality, interference, lack of confidence) is a multi-faceted measure of test anxiety. Each subscale consists of five items with a total of 20 questions overall. Response on a 4-point Likert-scale ranging from 1 (almost never) to 4 (almost always).

  from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam )

Secondary Outcomes (4)

• Change in the Pittsburgh Sleep Quality Index (PSQI)

  from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam )

• Change in Change-sensitive symptom list (ASS-SYM symptom list)

  from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam )

• test performance

  assessed two months after the exam

• semi-structured qualitative interview with open-ended questions

  30-60 min duration after personal study conclusion (1 to 5 weeks after exam)

Study Arms (3)

No treatment group

EXPERIMENTAL

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

Other: information about "No treatment group"

Imaginary pill (IP) group

EXPERIMENTAL

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)

Other: imaginary pill technique

Open label placebo group

EXPERIMENTAL

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

Other: open label placebo

Interventions

information about "No treatment group" OTHER

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

No treatment group

imaginary pill technique 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.

Imaginary pill (IP) group

open label placebo 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.

Open label placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Prof. Dr., Jens Gaab, Division of Clinical Psychology and Psychotherapy, University of Basel, Switzerland: collaborator
• Emer. Prof. Dr., Irving Kirsch, Universities of Hull and Plymouth, United Kingdom, and University of Connecticut, USA: collaborator
• Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark: collaborator
• Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal: collaborator
• Dr. phil., Cosima Locher, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA: collaborator

Study Sites (1)

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

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36788309 BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sarah Buergler, M. Sc.

  Division of Clinical Psychology and Psychotherapy, University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: March 6, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

CH (1)