Taking Open Label Placebo Further: Randomized Controlled Trial of Imaginary Pills in Test Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 177
- Locations
- 2
- Primary Endpoint
- Change in Prüfungsangstfragebogen (PAF) questionnaire
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- test performance(assessed two months after the exam)
- 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 ))
- semi-structured qualitative interview with open-ended questions(30-60 min duration after personal study conclusion (1 to 5 weeks after 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 ))