Fear Conditioning Paradigm in Obesity (GenAllertOB)

August 20, 2025 updated by: Istituto Auxologico Italiano

Implicit Reactions to Threats in Individuals With Obesity: Primary Evidence From Fear Conditioning Paradigm

Fear processing in obesity and specifically the ability to i) learn and remember threatening stimuli, and ii) implicitly (i.e., unconsciously) and explicitly (consciously) discriminate them from neutral ones, will be investigated in affected individuals through the fear-conditioning paradigm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VCO
      • Piancavallo, VCO, Italy, 28824
        • IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.

Description

Inclusion criteria:

  • Right-handed
  • diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).
Behavioral: Fear Conditioning

It is a 2-day paradigm. Participants will undergo an auditory fear conditioning task in 3 phases: (1) pre-conditioning habituation, (2) unconditioned stimulus (US) calibration, where USs will be delivered to set the individual stimulation intensity threshold, and (3) fear conditioning, in which participants will be exposed to the conditioned stimulus (CS) associated with the US with an 80% pairing rate. 24 hours later, the (1) implicit recognition of the CS and novel stimuli (NSs), and the (2) explicit recognition, through an alternative forced-choice task will be assessed. Also, (3) the perceptual discrimination (among the CS and NSs) will be tested.

Event-related skin conductance responses (SCRs) will be collected as an implicit index of defensive fear responses, while the accuracy in detecting and discriminating the CS from NSs as the explicit index. Psychological questionnaires about anxiety symptoms will be also administered.
Controls
Not-hospitalized participants with a healthy weight
Behavioral: Fear Conditioning

It is a 2-day paradigm. Participants will undergo an auditory fear conditioning task in 3 phases: (1) pre-conditioning habituation, (2) unconditioned stimulus (US) calibration, where USs will be delivered to set the individual stimulation intensity threshold, and (3) fear conditioning, in which participants will be exposed to the conditioned stimulus (CS) associated with the US with an 80% pairing rate. 24 hours later, the (1) implicit recognition of the CS and novel stimuli (NSs), and the (2) explicit recognition, through an alternative forced-choice task will be assessed. Also, (3) the perceptual discrimination (among the CS and NSs) will be tested.

Event-related skin conductance responses (SCRs) will be collected as an implicit index of defensive fear responses, while the accuracy in detecting and discriminating the CS from NSs as the explicit index. Psychological questionnaires about anxiety symptoms will be also administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCRs)
Time Frame: Baseline
The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recognition %
Time Frame: baseline
Level of accuracy (in %) in recognizing and discriminating the CS from NS will be computed. This will represent the explicit index.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21X101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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