Clinical trial NCT05331534: Effect of Attentional Therapy on Post-traumatic Stress Disorder
Official title: Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Post-traumatic stress disorder
Attentional bias
Eye tracking
Attention Control Training
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Primary outcomes:
measure: PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
timeFrame: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
Secondary outcomes:
measure: AB will be assessed in both groups by measuring the total fixation time on negative versus neutral images in a dot-probe task with eye tracking
timeFrame: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
measure: Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD
timeFrame: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
measure: The number of sessions of prolonged exposure therapy required to achieve a score below the clinical cut-off at the PTSD Checklist for DSM-5 (PCL5) (<33/80)
timeFrame: Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average
measure: Follow-up on psychotraumatic symptomatology will be assessed using the Clinician-Administered PTSD Scale (CAPS) score
timeFrame: One month after prolonged exposure therapy treatment, up to 6 months after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Vaiva, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: