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

Test Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250571
• Other study ID #: 035-19-1; ex20Gaab
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Test Anxiety

Intervention

Other:
• information about "No treatment group"
Participants will receive no pills and will be told that they are in the no treatment group
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel	Basel

Sponsors (6)

Lead Sponsor

Collaborator

University Hospital, Basel, Switzerland

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

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	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.	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	test performance	test performance (i.e., grade of the respective exam or pass/fail) of each participant	assessed two months after the exam
Secondary	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)	30-60 min duration after personal study conclusion (1 to 5 weeks after exam)