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The Role of Attention in Modulating the Placebo Effect

C

Catholic University of the Sacred Heart

Status

Enrolling

Conditions

Attention
Placebo Effect

Treatments

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06827444
Università Cattolica del Sacro

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

All

Ages

19 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
  • allergy and/or intolerance to caffeine.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

128 participants in 2 patient groups, including a placebo group

Placebo group
Placebo Comparator group
Treatment:
Other: Placebo
Control Group
Active Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Francesca NA Grosso, MD

Data sourced from clinicaltrials.gov

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