Post Traumatic Stress DisorderBATRAUMANCT05331534
Effect of Attentional Therapy on Post-traumatic Stress Disorder
A study of Post Traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2024to 2 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fabien D'HONDT, PhD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Fontan 2
Lille, 59037
Guillaume Vaiva
About this study
Official title: Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder
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
- Being tested
- Eye-tracking assisted attention control training (ACTo), Attention control training (ACT)
- Keywords
- Post-traumatic stress disorder, Attentional bias, Eye tracking, Attention Control Training
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-tracking assisted attention control training (ACTo)Behavioural
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.
Attention control training (ACT)Behavioural
Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s.
| Study group | Role | What they receive |
|---|---|---|
| patients with a PTSD receiving ACTo and prolonged exposure therapy. | Experimental | Not described Receives: Behavioral: Eye-tracking assisted attention control training (ACTo) |
| patients with PTSD receiving ACT and prolonged exposure therapy. | Sham comparator | Not described Receives: Behavioral: Attention control training (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
Secondary outcomes (4)
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
Measured: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion
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).
Measured: 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)
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.
Measured: Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average
Follow-up on psychotraumatic symptomatology will be assessed using the Clinician-Administered PTSD Scale (CAPS) score
Measured: One month after prolonged exposure therapy treatment, up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start2 Feb 2024
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Vaiva, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331534
- Sponsor's protocol ID
- 2021_0860
- Other IDs
- 2022-A00224-39
- Acronym
- BATRAUMA
- Status last verified
- Aug 2025
- First submitted
- 21 Mar 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Eye-tracking Assisted Attentional Bias Reduction Therapy on Reducing Symptoms of Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05331534
- Acronym / sponsor ID
- BATRAUMA / 2021_0860
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, Attentional bias, Eye tracking, Attention Control Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a PTSD receiving ACTo and prolonged exposure therapy. | Experimental | Behavioral: Eye-tracking assisted attention control training (ACTo) |
| patients with PTSD receiving ACT and prolonged exposure therapy. | Sham comparator | Behavioral: Attention control training (ACT) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | patients with a PTSD receiving ACTo and prolonged exposure therapy. |
| Attention control training (ACT)Patients will benefit from the ACT as described above; at each trial, images will remain on screen for 2s. | Behavioural | patients with PTSD receiving ACT and prolonged exposure therapy. |
Primary outcome
PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score.
Time frame: 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.
4 secondary outcomes
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
Calculation of correlation coefficients between pre- and post-treatment differences in AB and PTSD
Time frame: 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)
Time frame: Before each prolonged exposure therapy session: 1 month after inclusion, during 3 months on average
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabien D'HONDT, PhD contact
Guillaume Vaiva, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Post Traumatic Stress Disorder, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume VAIVA, MD,PhD (0320445962 ext. +33, guillaume.vaiva@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptomatology assessed using the Clinician-Administered PTSD Scale (CAPS) score. (time frame: Before and after ACTo or ACT treatment: at day 1 and 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.