Extrait

Background and study aims The nocebo effect is the flip side to the well-known placebo effect. This is where taking a dummy tablet such as a sugar pill can lead to the development of side effects or worsening of symptoms because of negative expectations. This nocebo effect is thought to be one of the reasons why many people report side effects to medications. This study aims to deliver an intervention to reduce the nocebo effect and therefore the number of side effects reported to medications. As a secondary aim we also want to determine which type of participants are more likely to experience nocebo effects. Who can participate? People can participate if they are male or female, over 18 years of age, healthy, and an English speaker and writer. What does the study involve? First participants will fill in questionnaires about their demographics, recent symptoms and personality features/beliefs. They will then receive one of two patient information leaflets to read. Both leaflets have been adapted for a dummy tablet and follow the current guidelines. One leaflet will report side effect probability following current guidelines, such as “common side effects (More than 1 in 10 people will be affected)”. The other leaflet will report the probability of possible side effects more positively and use percentages, such as “uncommon side effects (80% of people will not be affected).” Half of the participants will receive the first leaflet and the other half will receive the second leaflet. After reading the leaflet they will then fill in questionnaires about their anxiety, expectations for developing side effects and the quality of the leaflet. After this they will take one dummy tablet and complete a series of standardised cognitive tests for one hour. Next they will complete the anxiety questionnaire again as well as a questionnaire to record the number and severity of any symptoms experienced, and guess at the tablet identity (as participants are not told it is a dummy tablet). Finally participants will be asked a series of qualitative questions to understand more about their symptom experience and their thoughts on the tablet. They will then be thanked for their participation and given their monetary reward. Once all data collection has taken place they will be emailed a full description of the study. What are the possible benefits and risks of participating? It is unlikely that participants will experience direct benefit from the research, but many people state that they gain benefit from contributing to research that has important consequences for current practices. Even though participants will only take a dummy tablet, due to their expectations from reading the patient information leaflet, they have a 25% chance of developing side effects. The side effects are listed on the patient information leaflet and are short lasting and common in everyday life, such as headache and nausea. Where is the study run from? The study will run from one centre, the NIHR/Wellcome Trust King's Clinical Research Facility (UK). When is study starting and how long is it expected to run for? November 2015 to February 2017. Who is funding the study? NIHR Health Protection Research Unit (UK). Who is the main contact? Rebecca Webster [email protected]

Critère d'inclusion

• The nocebo effect

Liens

• isrctn
• ictrp