Post-Traumatic Stress DisorderSAILLANCE2NCT03519789
Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder (SAILLANCE2)
An observational study of Post-Traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to 5 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- a diagnosis of PTSD based on the standard DSM-IV criteria,
- normal or corrected vision.
- clinically stable at the testing time
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Change blindness, Eye tracking, Implicit response
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-Traumatic Stress Disorders (PTSD) | 30 patients with PTSD (diagnosis based on the standard DSM criteria) | |
| Controls | 30 healthy controls without any psychiatric or neurological diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time before the detection of neutral and emotional stimuli.
The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.
Measured: Baseline: one session
Secondary outcomes (2)
Number of correct detections compared with the missed detections and false alarms.
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.
Measured: Baseline: one session
Total duration until the participant first fixed on a ROI.
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.
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study startMay 2014
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume VAIVA, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519789
- Sponsor's protocol ID
- 2013_19.2
- Other IDs
- 2013-A01498-37
- Acronym
- SAILLANCE2
- Status last verified
- Aug 2020
- First submitted
- 26 Apr 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39314214Veerapa 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.
PubMed 36259422Veerapa 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.
PubMed 32678129
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03519789
- Acronym / sponsor ID
- SAILLANCE2 / 2013_19.2
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Change blindness, Eye tracking, Implicit response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Traumatic Stress Disorders (PTSD) | – | –30 patients with PTSD (diagnosis based on the standard DSM criteria) |
| Controls | – | –30 healthy controls without any psychiatric or neurological diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- a diagnosis of PTSD based on the standard DSM-IV criteria,
- normal or corrected vision.
- clinically stable at the testing time
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response time before the detection of neutral and emotional stimuli.
Time frame: Baseline: one session
The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.
2 secondary outcomes
Number of correct detections compared with the missed detections and false alarms.
Time frame: Baseline: one session
Total duration until the participant first fixed on a ROI.
Time frame: Baseline: one session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 39314214Creupelandt 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.
- Results publication: PubMed 36259422Veerapa 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.
- Results publication: PubMed 32678129Veerapa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume VAIVA principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time before the detection of neutral and emotional stimuli. (time frame: Baseline: one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03519789, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.