Clinical trial NCT04250571: 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
Overall status: COMPLETED
Phase: NA
Conditions: Test Anxiety
Keywords: imaginary pills
open label placebo (OLP) treatment
placebo
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Prof. Dr., Jens Gaab, Division of Clinical Psychology and Psychotherapy, University of Basel, Switzerland
name: Emer. Prof. Dr., Irving Kirsch, Universities of Hull and Plymouth, United Kingdom, and University of Connecticut, USA
name: Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark
name: Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal
name: Dr. phil., Cosima Locher, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
First posted: 2020-01-31
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Change in Prüfungsangstfragebogen (PAF) questionnaire
timeFrame: 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:
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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 )
measure: Change in Change-sensitive symptom list (ASS-SYM symptom list)
timeFrame: 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 )
measure: test performance
timeFrame: assessed two months after the exam
measure: semi-structured qualitative interview with open-ended questions
timeFrame: 30-60 min duration after personal study conclusion (1 to 5 weeks after exam)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel
Study officials:
affiliation: Division of Clinical Psychology and Psychotherapy, University of Basel
name: Sarah Buergler, M. Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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.