Effect of Attentional Therapy on Post-traumatic Stress Disorder

Not Applicable

Not yet recruiting

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Attention control training (ACT); Behavioral: Eye-tracking assisted attention control training (ACTo)

• Registration Number: NCT05331534
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Study Start: 2022-09
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with PTSD receiving ACT and prolonged exposure therapy.	Attention control training (ACT)	-
patients with a PTSD receiving ACTo and prolonged exposure therapy.	Eye-tracking assisted attention control training (ACTo)	-

Primary Outcome Measures

Name	Time	Method
PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.	Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion	The CAPS-5 is a 30-item structured interview corresponding to the DSM-5 diagnosis for PTSD. The CAPS-5 combines information about frequency and intensity of an item into a single severity rating (range 0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster. Higher scores thus correspond to higher severity of PTSD symptoms.

Secondary Outcome Measures

Name	Time	Method
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	Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
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)	Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average	The PTSD Checklist for DSM-5 (PCL5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate more symptoms of PTSD. A score above 32 suggests a probable PTSD.
Follow-up on psychotraumatic symptomatology will be assessed using the Clinician-Administered PTSD Scale (CAPS) score	One month after prolonged exposure therapy treatment, up to 6 months after inclusion
Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD	Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion	AB will be measured by total fixation time on negative versus neutral images in a dot-probe task with eye tracking; and psychotraumatic symptomatology will be measured by the Clinician-Administered PTSD Scale (CAPS).