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OpenTrials
Completed

NCT Number: NCT05768659

Fear Conditioning Paradigm in Obesity

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.

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Key information

Conditions

Obesity Anxiety Disorders Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fear Conditioning

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: GenAllertOB

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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