Fear Conditioning Paradigm in Obesity

Obesity Clinical Trial

— GenAllertOB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768659
• Other study ID #: 21X101
• Status: Completed
• Start date: June 7, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCRs)	The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.	Baseline
Secondary	Recognition %	Level of accuracy (in %) in recognizing and discriminating the CS from NS will be computed. This will represent the explicit index.	baseline