GenAllertOB: Fear Conditioning Paradigm in Obesity

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Completed

CT.gov ID

NCT05768659

Collaborator

(none)

Enrollment

Location

4.4

Actual Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Fear Conditioning

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 7, 2022

Actual Primary Completion Date :

Oct 20, 2022

Actual Study Completion Date :

Oct 20, 2022

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

SCRs) [Baseline]
The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.

Secondary Outcome Measures

Recognition % [baseline]
Level of accuracy (in %) in recognizing and discriminating the CS from NS will be computed. This will represent the explicit index.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO	Italy	28824

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05768659

Other Study ID Numbers:

21X101

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Auxologico Italiano

fear conditioning

fear processing

anxiety

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Mar 14, 2023