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

Primary Purpose

Test Anxiety

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
information about "No treatment group"
imaginary pill technique
open label placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Test Anxiety focused on measuring imaginary pills, open label placebo (OLP) treatment, placebo

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No treatment group

Imaginary pill (IP) group

Open label placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is an 18 item self-rating questionnaire forming 7 subscales and includes frequency of sleep disturbing events, the assessment of sleep quality, the usual sleep times, sleep latency and sleep duration, the intake of sleep medications, as well as daytime fatigue.
Change in Change-sensitive symptom list (ASS-SYM symptom list)
ASS-SYM symptom list It is composed of 48 items arranged in 6 subscales: physical and psychological exhaustion, nervousness and mental tension, psycho-physiological dysregulation, performance and behavioral problems, burden of pain as well as self-determination and self-control problems.
test performance
test performance (i.e., grade of the respective exam or pass/fail) of each participant
semi-structured qualitative interview with open-ended questions
qualitative interview to assess the subjective experiences, opinions and perceptions of (1) receiving the imaginary pill (N=10) and open label placebo (N=10) treatment, (2) their experiences during the three week intervention phase, (3) the exam situation (4) and thoughts about the use in the future. Participants of the no treatment group are not included. The data will be analyzed using a qualitative content analysis after Mayring (Mayring, 2014)

Full Information

First Posted
January 29, 2020
Last Updated
August 23, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Prof. Dr., Jens Gaab, Division of Clinical Psychology and Psychotherapy, University of Basel, Switzerland, Emer. Prof. Dr., Irving Kirsch, Universities of Hull and Plymouth, United Kingdom, and University of Connecticut, USA, Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark, Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal, Dr. phil., Cosima Locher, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
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1. Study Identification

Unique Protocol Identification Number
NCT04250571
Brief Title
Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety
Official Title
Taking Open Label Placebo Further: Randomized Controlled Trial of Imaginary Pills in Test Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Test Anxiety
Keywords
imaginary pills, open label placebo (OLP) treatment, placebo

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No treatment group
Arm Type
Experimental
Arm Description
Participants will receive no pills and will be told that they are in the no treatment group
Arm Title
Imaginary pill (IP) group
Arm Type
Experimental
Arm Description
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)
Arm Title
Open label placebo group
Arm Type
Experimental
Arm Description
Participants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo")
Intervention Type
Other
Intervention Name(s)
information about "No treatment group"
Intervention Description
Participants will receive no pills and will be told that they are in the no treatment group
Intervention Type
Other
Intervention Name(s)
imaginary pill technique
Intervention Description
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
Intervention Name(s)
open label placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Prüfungsangstfragebogen (PAF) questionnaire
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Change in the Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is an 18 item self-rating questionnaire forming 7 subscales and includes frequency of sleep disturbing events, the assessment of sleep quality, the usual sleep times, sleep latency and sleep duration, the intake of sleep medications, as well as daytime fatigue.
Time Frame
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 )
Title
Change in Change-sensitive symptom list (ASS-SYM symptom list)
Description
ASS-SYM symptom list It is composed of 48 items arranged in 6 subscales: physical and psychological exhaustion, nervousness and mental tension, psycho-physiological dysregulation, performance and behavioral problems, burden of pain as well as self-determination and self-control problems.
Time Frame
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 )
Title
test performance
Description
test performance (i.e., grade of the respective exam or pass/fail) of each participant
Time Frame
assessed two months after the exam
Title
semi-structured qualitative interview with open-ended questions
Description
qualitative interview to assess the subjective experiences, opinions and perceptions of (1) receiving the imaginary pill (N=10) and open label placebo (N=10) treatment, (2) their experiences during the three week intervention phase, (3) the exam situation (4) and thoughts about the use in the future. Participants of the no treatment group are not included. The data will be analyzed using a qualitative content analysis after Mayring (Mayring, 2014)
Time Frame
30-60 min duration after personal study conclusion (1 to 5 weeks after exam)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Buergler, M. Sc.
Organizational Affiliation
Division of Clinical Psychology and Psychotherapy, University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36788309
Citation
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.
Results Reference
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Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety

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