Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder (SAILLANCE2)

Completed

• Conditions: Post-Traumatic Stress Disorder

• Registration Number: NCT03519789
• Lead Sponsor: University Hospital, Lille

Brief Summary

Post-traumatic stress disorder (PTSD) is characterized by hypervigilance. In particular, previous works suggest that patients tend to scan constantly the environment for possible threats. The present project aims at investigating such attentional bias in patients with PTSD using the change blindness paradigm that offers the interesting possibility of studying sensitivity to sudden changes using ecological stimuli. More precisely, the investigators will investigate whether patients are more sensitive than matched controls to sudden changes in the visual environment and whether this hypersensitivity is specific or even stronger when visual information has an emotional content. The attentional bias will be measured using motor responses (accuracy and speed to indicate the occurrence of a change by pressing a button) as well as eye movements.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• a diagnosis of PTSD based on the standard DSM-IV criteria,
• normal or corrected vision.
• clinically stable at the testing time

Exclusion Criteria

• history of neurological illness or trauma that occurred in the previous six months, - pregnant and nursing women,
• drugs use in the last 24 hours,
• an acute ocular disorder.
• Participants will not be under tutorship, curatorship or deprived of liberty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response time before the detection of neutral and emotional stimuli.	Baseline: one session	The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.

Secondary Outcome Measures

Name	Time	Method
Number of correct detections compared with the missed detections and false alarms.	Baseline: one session	Performances will be measured by a sensitivity index (D prime) . This sensitivity index considers the number of correct detections compared with the missed detections and false alarms.
Total duration until the participant first fixed on a ROI.	Baseline: one session	The implicit response will be measured by the localization and duration of fixations. All fixations outside the recording field will be excluded. The main variable will be the mean latency of the first fixation in a region of interest (ROI). This variable corresponds to the total duration until the participant first fixed on a ROI.

Trial Locations

Locations (1)

University Hospital, Lille; 🇫🇷 Lille, France