The Role of Attention in Modulating the Placebo Effect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-99
SponsorCatholic University of the Sacred Heart
About this trial
This project aims to examine whether these forms of attention to sensory information can modulate the mind-body interaction. This will be demonstrated through a study focused on the placebo effect with attention manipulation. Specifically, the project will focus on the construct of mindful attention to increase the precision of the likelihood and reduce the effects of priors, and on directed attention to modify the position and precision of the likelihood, hypothetically modulating the placebo effect.
The study involves recruiting 128 healthy individuals, who will be asked to cycle on an ergometer for approximately 60 minutes, with alternating phases in which attention will be manipulated. After an initial warm-up phase, they will receive a placebo drink, presented as "highly stimulating." An additional group of 32 participants will not receive either the placebo drink or the attentional stimuli, but will undergo the same training cycles. All participants will receive a pre-intervention assessment, and heart rate, emotions, and perceived fatigue will be monitored.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Persons (18+) in good health, verified by presenting a medical certificate (sporting, competitive or non-competitive, or of good health).
Be available to go to a gym. If not enrolled, the cost of admission is borne by the project.
Disqualifiers
known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
allergy and/or intolerance to caffeine.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionParticipants will be provided with a chest strap for heart rate measurement (the strap will be washed and disinfected after each session), connected to the Polar Beat app downloaded by the researcher. Subsequently, each participant will perform an initial 10-minute baseline warm-up session (a cadence of 70-80 RPM will be requested). From the cycle ergometer display, values for watts (the amount of work done per second), power (the amount of work done over a certain period of time), and speed (expressed in kilometers per hour) will also be extracted. During the test, no visual or verbal feedback will be provided. Participants will be blind to the cycle ergometer screen, so the data will not influence their behavior. Heart rate will be continuously recorded throughout the exercise period and during the participant's recovery. Participants will then be randomized to one of the following manipulations.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fatigue
Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.
Time frame
30 minutesSecondary outcomes
1
Heart rate
Heart rate beats, assessed with Polar H10 chest strap
Time frame
30 minutes2
Perceived efficacy of the energy drink
Numeric Rating Scale 0-10, where 10 is the most effective.
Time frame
30 minutesOther outcomes
1
Mindfulness
The Mindfulness Awareness Attention Scale (MAAS) is a widely used self-report measure designed to assess an individual's level of mindfulness, particularly focusing on present-moment awareness and attention. Developed by MacKillop and Anderson (2007), the scale evaluates the frequency of mindful states in everyday life, emphasizing the ability to remain attentive to and aware of current experiences. The MAAS has been extensively applied in both clinical and non-clinical settings to explore the relationship between mindfulness and various psychological and behavioral outcomes, such as stress reduction, emotional regulation, and overall well-being.
Time frame
Once, at the baseline (pre-experiment)2
Anxiety
The Beck Anxiety Inventory (BAI) is a widely used self-report measure designed to assess the severity of anxiety symptoms. Developed by Beck et al. (1988), the scale focuses on somatic and subjective symptoms of anxiety, such as nervousness, fear, and physical sensations like sweating or dizziness. The BAI is commonly used in both clinical and research settings to screen for anxiety disorders, monitor symptom changes over time, and evaluate the effectiveness of therapeutic interventions. Its reliability and ease of use make it a valuable tool for assessing anxiety across diverse populations.
Time frame
Once, at the baseline (pre-experiment)3
Stress
The Perceived Stress Scale (PSS) is a widely used self-report tool designed to measure the level of stress an individual perceives in their daily life. Developed by Cohen et al. (1994), the scale evaluates how unpredictable, uncontrollable, and overwhelming respondents find their life circumstances over the past month. The PSS is often employed in both research and clinical settings to assess stress levels, explore its impact on health outcomes, and monitor changes following interventions aimed at stress reduction. Its versatility and simplicity make it suitable for diverse populations and contexts.
Time frame
Once, at the baseline (pre-experiment)4
Optimism
The Life Orientation Test - Revised (LOT-R) is a psychological assessment tool designed to measure individual differences in dispositional optimism. Developed by Scheier et al. (1994), the LOT-R evaluates the extent to which individuals hold positive expectations about future outcomes. This self-report scale is widely used in both research and clinical settings to examine the role of optimism in psychological well-being, health outcomes, and coping strategies. Its concise format and strong psychometric properties make it a valuable instrument for exploring optimism across various populations and contexts.
Time frame
Once, at the baseline (pre-experiment)Sponsors and contacts
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Source ClinicalTrials.gov