NCT05331534 Effect of Attentional Therapy on Post-traumatic Stress Disorder
| NCT ID | NCT05331534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2028-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-02-02 with a primary completion date of 2028-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-traumatic stress disorder (PTSD) is associated with an attentional bias towards negative stimuli, which is supposed to contribute to the development and the maintenance of the disorder. We recently showed using eye-tracking evidenced two types of AB towards negative stimuli: a "physiological AB" found both in healthy and individual with PTSD, characterized by a stronger initial attentional engagement towards negative stimuli compared to neutral stimuli, as revealed by longer first fixation duration dwell time on negative pictures than on neutral pictures; a "pathological bias" observed only in individuals with PTSD and characterized by an heightened sustained attention towards negative stimuli once detected, which further increases with prolonged exposure. The present study aimed at assessing the effectiveness of an eye-tracking assisted attentional bias reduction therapy, targeting specifically the pathological bias on the reduction of PTSD symptoms
Eligibility Criteria
Inclusion Criteria: * Understanding and able to express themselves in French * Giving informed consent, by dating and signing the study participation form * Having health insurance coverage * Normal or corrected to normal vision and hearing * DSM-5 PTSD criteria, assessed using the CAPS and PCL-5 Exclusion Criteria: * Minors or adults under guardianship, under judicial protection, persons deprived of liberty * Pregnant or breastfeeding women * Refusal to participate after being clearly and fairly informed about the study * Sensory, visual or auditory incapacity to participate in the study * Personal history of neurological disorder or current neurological disorder * Use of drugs other than tobacco and alcohol * Alcohol use on the day of experimentation * Personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma and stress disorders assessed at clinical interview and with MINI * Personal history of multiple trauma in childhood * Psychotropic medication treatment not stabilized over the past 4 weeks * MOCA \< 26 * Contraindication to prolonged exposure therapy
Contact & Investigator
Guillaume Vaiva, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05331534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05331534 currently recruiting?
Yes, NCT05331534 is actively recruiting participants. Contact the research team at guillaume.vaiva@chru-lille.fr for enrollment information.
Where is the NCT05331534 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05331534 clinical trial?
NCT05331534 is sponsored by University Hospital, Lille. The principal investigator is Guillaume Vaiva, MD,PhD at University Hospital, Lille. The trial plans to enroll 140 participants.