Effect of Attentional Therapy on Post-traumatic Stress Disorder (BATRAUMA)

University Hospital, Lille

Status: Enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Attention control training (ACT); Behavioral: Eye-tracking assisted attention control training (ACTo)

Study type: Interventional

Funder types: Other

Identifiers

NCT05331534

2022-A00224-39 (Other Identifier)

2021_0860

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

patients with a PTSD receiving ACTo and prolonged exposure therapy.

Experimental group

Treatment:

Behavioral: Eye-tracking assisted attention control training (ACTo)

patients with PTSD receiving ACT and prolonged exposure therapy.

Sham Comparator group

Treatment:

Behavioral: Attention control training (ACT)