Effect of Attentional Therapy on Post-traumatic Stress Disorder

NCT ID: NCT05331534

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2029-02-02

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

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

patients with a PTSD receiving ACTo and prolonged exposure therapy.

Group Type: EXPERIMENTAL

Eye-tracking assisted attention control training (ACTo)

Intervention Type: BEHAVIORAL

ACT is made of 8 sessions of a Dot-Probe Task (DPT). The DPT is a computerized task in which two visual stimuli (one emotional stimulus and one neutral stimulus) are displayed simultaneously on the left and right side of the screen. AB towards or away from emotional stimuli is respectively inferred by faster or slower responses to detect a probe replacing an emotional stimulus than a probe replacing a neutral stimulus. In the ACT therapy, the probe replaces the negative and neutral stimuli with equal frequency.

ACTo will combine ACT with eye tracking methodology, allowing to directly record eye movements of the participants during the task. At each trial, images will be displayed for 2s and the negative image will be replaced by the neutral image (and vice versa) if the patient continues to explore the negative image beyond the first fixation, in order to block any additional attentional engagement.

patients with PTSD receiving ACT and prolonged exposure therapy.

Group Type: SHAM_COMPARATOR

Attention control training (ACT)

Intervention Type: BEHAVIORAL

Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.

Interventions

Eye-tracking assisted attention control training (ACTo)

ACT is made of 8 sessions of a Dot-Probe Task (DPT). The DPT is a computerized task in which two visual stimuli (one emotional stimulus and one neutral stimulus) are displayed simultaneously on the left and right side of the screen. AB towards or away from emotional stimuli is respectively inferred by faster or slower responses to detect a probe replacing an emotional stimulus than a probe replacing a neutral stimulus. In the ACT therapy, the probe replaces the negative and neutral stimuli with equal frequency.

ACTo will combine ACT with eye tracking methodology, allowing to directly record eye movements of the participants during the task. At each trial, images will be displayed for 2s and the negative image will be replaced by the neutral image (and vice versa) if the patient continues to explore the negative image beyond the first fixation, in order to block any additional attentional engagement.

Intervention Type: BEHAVIORAL

Attention control training (ACT)

Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Vaiva, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Fontan 2

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume VAIVA, MD,PhD

Role: CONTACT

guillaume.vaiva@chru-lille.fr

0320445962 ext. +33

Fabien D'HONDT, PhD

Role: CONTACT

fabien.d-hondt@univ-lille.fr

Facility Contacts

Guillaume Vaiva

Role: primary

Other Identifiers

2022-A00224-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0860

Identifier Type: -

Identifier Source: org_study_id