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NCT Number: NCT04250571

Taking Open Label Placebo Further: 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).

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Key information

Conditions

Test Anxiety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 technique

Other

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 Placebo

Other

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.

Primary outcomes

  1. 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

  1. 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 )

    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.

  2. 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 )

    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.

  3. test performance

    Time frame: assessed two months after the exam

    test performance (i.e., grade of the respective exam or pass/fail) of each participant

  4. semi-structured qualitative interview with open-ended questions

    Time frame: 30-60 min duration after personal study conclusion (1 to 5 weeks after exam)

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Asst. Prof. Dr., Claudia Carvalho, Department of Clinical and Health Psychology ISPA, Lisbon, Portugal
  • Boston Children's Hospital
  • Cand. psych., Niels Bagge, Institut for Emotionsfokuseret Terapi, Roskilde, Denmark
  • Emer. Prof. Dr., Irving Kirsch, Universities of Hull and Plymouth, United Kingdom, and University of Connecticut, USA
  • Prof. Dr., Jens Gaab, Division of Clinical Psychology and Psychotherapy, University of Basel, Switzerland

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2020
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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