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

University Hospital Basel

Status: Completed

Conditions: Test Anxiety

Treatments: Other: information about "No treatment group"; Other: imaginary pill technique; Other: open label placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04250571

035-19-1 ex20Gaab;

Details and patient eligibility

About

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).

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 3 patient groups

No treatment group

Experimental group

Description:

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

Treatment:

Other: information about "No treatment group"

Imaginary pill (IP) group

Experimental group

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)

Treatment:

Other: imaginary pill technique

Open label placebo group

Experimental group

Description:

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

Treatment:

Other: open label placebo