Test AnxietyNCT04250571
Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety
A study testing information about "No treatment group" and imaginary pill technique in people with Test Anxiety, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Test Anxiety
- What is being tested?
- information about "No treatment group" and imaginary pill technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Mar 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Being a master student in Psychology
- Allergy of one of the ingredients of the placebo pills (P-Dragees blue Lichtenstein)
- Problems to swallow pills
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel
Basel, 4031
About this study
Official title: Taking Open Label Placebo Further: Randomized Controlled Trial of Imaginary Pills in Test Anxiety
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
- Being tested
- information about "No treatment group", imaginary pill technique, open label placebo
- Keywords
- imaginary pills, open label placebo (OLP) treatment, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
information about "No treatment group"Other
Participants will receive no pills and will be told that they are in the no treatment group
imaginary pill techniqueOther
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 placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No treatment group | Experimental | Participants will receive no pills and will be told that they are in the no treatment group Receives: 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) Receives: 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") Receives: Other: open label placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
test performance (i.e., grade of the respective exam or pass/fail) of each participant
Measured: assessed two months after the exam
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)
Measured: 30-60 min duration after personal study conclusion (1 to 5 weeks after exam)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start6 Mar 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Test AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- 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, Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Sarah Buergler, M. Sc., Principal investigator, Division of Clinical Psychology and Psychotherapy, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250571
- Sponsor's protocol ID
- 035-19-1; ex20Gaab
- Status last verified
- Aug 2023
- First submitted
- 29 Jan 2020
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36788309
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Open Label Placebo Further: Randomized Controlled Trial of Imaginary Pills in Test Anxiety
- ClinicalTrials.gov ID
- NCT04250571
- Acronym / sponsor ID
- 035-19-1; ex20Gaab
- Conditions
- Test Anxiety
- Keywords
- imaginary pills, open label placebo (OLP) treatment, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- 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, Boston Children's Hospital
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment group | Experimental | 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 (IP) group | Experimental | Other: imaginary pill techniqueParticipants 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) |
| Open label placebo group | Experimental | Other: open label placeboParticipants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo") |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| information about "No treatment group"Participants will receive no pills and will be told that they are in the no treatment group | Other | No treatment group |
| imaginary pill techniqueParticipants 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. | Other | Imaginary pill (IP) group |
| open label placeboParticipants 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. | Other | Open label placebo group |
Primary outcome
Change in Prüfungsangstfragebogen (PAF) questionnaire
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 )
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).
4 secondary outcomes
Change in the Pittsburgh Sleep Quality Index (PSQI)
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 )
Change in Change-sensitive symptom list (ASS-SYM symptom list)
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 )
test performance
Time frame: assessed two months after the exam
semi-structured qualitative interview with open-ended questions
Time frame: 30-60 min duration after personal study conclusion (1 to 5 weeks after exam)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 36788309Buergler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Buergler, M. Sc. principal investigator
Division of Clinical Psychology and Psychotherapy, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing information about "No treatment group" and imaginary pill technique in people with Test Anxiety, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prüfungsangstfragebogen (PAF) questionnaire (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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.