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

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

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Collaborator: 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
Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark
Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal

Source University Hospital, Basel, Switzerland
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).

Overall Status Recruiting
Start Date 2020-03-06
Completion Date 2021-08-01
Primary Completion Date 2021-08-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Prüfungsangstfragebogen (PAF) questionnaire 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 Time Frame
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)
Enrollment 165
Condition
Intervention

Intervention Type: Other

Intervention Name: information about "No treatment group"

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

Arm Group Label: No treatment group

Intervention Type: Other

Intervention Name: imaginary pill technique

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.

Arm Group Label: Imaginary pill (IP) group

Intervention Type: Other

Intervention Name: open label placebo

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.

Arm Group Label: Open label placebo group

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sarah Buergler, M. Sc. Principal Investigator Division of Clinical Psychology and Psychotherapy, University of Basel
Overall Contact

Last Name: Sarah Buergler, M. Sc.

Phone: +41 61 207 61 90

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Division of Clinical Psychology and Psychotherapy Department of Psychology, University of Basel, Sarah Buergler, M. Sc. [email protected] Jens Gaab, Prof. Dr. med Sub-Investigator Dilan Sezer, M. Sc. Sub-Investigator
Location Countries

Switzerland

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: No treatment group

Type: Experimental

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

Label: Imaginary pill (IP) group

Type: Experimental

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)

Label: Open label placebo group

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

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