Fear Conditioning Paradigm in Obesity

NCT ID: NCT05768659

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-07

Study Completion Date

2024-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).

Fear Conditioning

Intervention Type BEHAVIORAL

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

Fear Conditioning

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, Italy

Site Status

Countries

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Italy

Other Identifiers

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21X101

Identifier Type: -

Identifier Source: org_study_id

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