- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519789
Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder (SAILLANCE2) (SAILLANCE2)
May 11, 2026 updated by: University Hospital, Lille
Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lille, France, 59037
- University Hospital, Lille
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Thirty patients with PTSD and 30 participants exposed to trauma without PTSD will be asked to detect neutral or emotional changes in 96 scenes.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Controls
30 healthy controls without any psychiatric or neurological diagnosis
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Post-Traumatic Stress Disorders (PTSD)
30 patients with PTSD (diagnosis based on the standard DSM criteria)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Response time before the detection of neutral and emotional stimuli.
Time Frame: Baseline: one session
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The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.
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Baseline: one session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of correct detections compared with the missed detections and false alarms.
Time Frame: Baseline: one session
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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.
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Baseline: one session
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Total duration until the participant first fixed on a ROI.
Time Frame: Baseline: one session
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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.
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Baseline: one session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillaume VAIVA, University Hospital, Lille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Creupelandt C, Veerapa E, Bugnet A, Wathelet M, Demesmaeker A, Grandgenevre P, Vaiva G, Fovet T, D'Hondt F. Comment on: Attentional bias modification and attention control training in PTSD: a systematic review and meta-analysis. Ther Adv Psychopharmacol. 2024 Sep 17;14:20451253241278872. doi: 10.1177/20451253241278872. eCollection 2024. No abstract available.
- Veerapa E, Grandgenevre P, Vaiva G, Duhem S, Fayoumi ME, Vinnac B, Szaffarczyk S, Wathelet M, Fovet T, D'Hondt F. Attentional bias toward negative stimuli in PTSD: an eye-tracking study. Psychol Med. 2023 Sep;53(12):5809-5817. doi: 10.1017/S0033291722003063. Epub 2022 Oct 19.
- Veerapa E, Grandgenevre P, El Fayoumi M, Vinnac B, Haelewyn O, Szaffarczyk S, Vaiva G, D'Hondt F. Attentional bias towards negative stimuli in healthy individuals and the effects of trait anxiety. Sci Rep. 2020 Jul 16;10(1):11826. doi: 10.1038/s41598-020-68490-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
May 5, 2020
Study Completion (Actual)
May 5, 2020
Study Registration Dates
First Submitted
April 26, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (Actual)
May 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013_19.2
- 2013-A01498-37 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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