search
Back to results

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

Primary Purpose

Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eye-tracking assisted attention control training (ACTo)
Attention control training (ACT)
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Traumatic Stress Disorder focused on measuring Post-traumatic stress disorder, Attentional bias, Eye tracking, Attention Control Training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    patients with a PTSD receiving ACTo and prolonged exposure therapy.

    patients with PTSD receiving ACT and prolonged exposure therapy.

    Arm Description

    Outcomes

    Primary Outcome Measures

    PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
    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

    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
    Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD
    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).
    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)
    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

    Full Information

    First Posted
    March 21, 2022
    Last Updated
    April 11, 2022
    Sponsor
    University Hospital, Lille
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05331534
    Brief Title
    Effect of Attentional Therapy on Post-traumatic Stress Disorder
    Acronym
    BATRAUMA
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2027 (Anticipated)
    Study Completion Date
    September 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder
    Keywords
    Post-traumatic stress disorder, Attentional bias, Eye tracking, Attention Control Training

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with a PTSD receiving ACTo and prolonged exposure therapy.
    Arm Type
    Experimental
    Arm Title
    patients with PTSD receiving ACT and prolonged exposure therapy.
    Arm Type
    Sham Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Eye-tracking assisted attention control training (ACTo)
    Intervention Description
    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
    Intervention Name(s)
    Attention control training (ACT)
    Intervention Description
    Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.
    Primary Outcome Measure Information:
    Title
    PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
    Description
    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.
    Time Frame
    Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
    Title
    Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD
    Description
    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).
    Time Frame
    Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
    Title
    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)
    Description
    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.
    Time Frame
    Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average
    Title
    Follow-up on psychotraumatic symptomatology will be assessed using the Clinician-Administered PTSD Scale (CAPS) score
    Time Frame
    One month after prolonged exposure therapy treatment, up to 6 months after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guillaume VAIVA, MD,PhD
    Phone
    0320445962
    Ext
    +33
    Email
    guillaume.vaiva@chru-lille.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabien D'HONDT, PhD
    Email
    fabien.d-hondt@univ-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guillaume Vaiva, MD,PhD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Attentional Therapy on Post-traumatic Stress Disorder

    We'll reach out to this number within 24 hrs