The Role of Attention in Modulating the Placebo Effect

NCT06827444 | Recruiting

• 1 other identifier: Università Cattolica del Sacro
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Placebo Effect; Attention

Keywords

Placebo; Bayesiana approach; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Numeric Rating Scale 0-10, where 10 indicates maximum fatigue.

  30 minutes

Secondary Outcomes (2)

• Heart rate

  30 minutes

• Perceived efficacy of the energy drink

  30 minutes

Other Outcomes (6)

• Mindfulness

  Once, at the baseline (pre-experiment)

• Anxiety

  Once, at the baseline (pre-experiment)

• Stress

  Once, at the baseline (pre-experiment)

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Other: Placebo

Control Group

ACTIVE COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Participants 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.

Control Group; Placebo group

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Università Cattolica del Sacro Cuore

Milan, Milano, 20123, Italy

RECRUITING

Study Officials

• Francesca NA Grosso, MD

  Catholic University of the Sacred Heart

  STUDY DIRECTOR

Central Study Contacts

Francesca NA Grosso, MD

CONTACT

3405594270; francesca.grosso@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: February 14, 2025
• Study Start: March 7, 2024
• Primary Completion: December 12, 2024
• Study Completion: May 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)