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

NCT03519789 | Completed

• 2 other identifiers: 2013_19.22013-A01498-37
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Change blindness; Eye tracking; Implicit response

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline: one session

Secondary Outcomes (2)

• Number of correct detections compared with the missed detections and false alarms.

  Baseline: one session

• Total duration until the participant first fixed on a ROI.

  Baseline: one session

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

University Hospital, Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Guillaume VAIVA

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: May 1, 2014
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

FR (1)