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Post-Traumatic Stress Disorder (PTSD)NCT07523360

A Digital Cognitive Intervention for Intrusive Memories After Trauma

A study testing Pre-selected Trauma-related Cue Images with Eye Movement, Patient-provided Trauma-related Cue Images with Eye Movement and Neutral Images with Eye Movement in people with Post-Traumatic Stress Disorder (PTSD) and Intrusive Memories of Traumatic Event(s), run by Zhu Zijian at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Intrusive traumatic memories frequently trigger severe distress and psychological disorders such as post-traumatic stress disorder (PTSD). Traditional therapies require explicit trauma recall, which often causes severe patient distress and may lead to treatment avoidance. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Pre-selected Trauma-related Cue Images with Eye Movement, Patient-provided Trauma-related Cue Images with Eye Movement and Neutral Images with Eye Movement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteChina
Study dates
10 Jun 2026to 10 Jul 2028
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for post-traumatic stress disorder (PTSD), which requires exposure to an event involving serious injury or a threat to one's own or another person's physical well-being, either through direct experience or witnessing.
  • Exhibit symptoms from at least three of the five core PTSD symptom domains outlined in DSM-5: intrusive memories (Criterion B), persistent avoidance of trauma-related stimuli (Criterion C), negative alterations in cognitions and mood (Criterion D), alterations in arousal and reactivity (Criterion E), and symptoms lasting for at least one month (Criterion F).
  • Have a total score of 33 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
  • Have internet access and access to a personal computer.
  • Have not taken part in a previous study of this intervention conducted by this research team.

Who cannot join

  • Fewer than 5 intrusive memories during the baseline week (Week 0).
  • An intelligence quotient (IQ) score lower than 80.
  • A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior.
  • Severe substance dependence.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • School of Psychology, Shaanxi Normal University

    Xi'an, Shaanxi, 710062

    Recruiting

Other trials in China

About this study

Official title: A Novel Digital Cognitive Intervention Targeting Intrusive Memories Among Trauma-Exposed Individuals: A Randomised Clinical Trial

Intrusive traumatic memories frequently trigger severe distress and psychological disorders such as post-traumatic stress disorder (PTSD). Traditional therapies require explicit trauma recall, which often causes severe patient distress and may lead to treatment avoidance. To address this, our study introduces a less aversive intervention that combines unconscious visual processing with bilateral eye movements to reduce intrusive traumatic memories. Utilizing a randomized, three-arm design, we will compare standardized trauma-related images, patient-provided images, and neutral images, all paired with bilateral eye movements. We plan to recruit participants who have experienced severe trauma and report at least 5 intrusive memories per week, with a target final sample of 40 participants per arm. The primary outcome is the frequency of intrusive memories. Secondary and additional outcomes include PTSD severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the PTSD Checklist for DSM-5 (PCL-5), and the Impact of Event Scale (IES), as well as depression, anxiety, borderline symptoms, functional improvement, subjective intervention distress, and dropout rates.

Read the detailed description

This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results.

Being tested
Pre-selected Trauma-related Cue Images with Eye Movement, Patient-provided Trauma-related Cue Images with Eye Movement, Neutral Images with Eye Movement
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.

  • Pre-selected Trauma-related Cue Images with Eye MovementBehavioural

    After the baseline diary period, participants perform a continuous bilateral eye-movement task while being concurrently exposed to subliminally presented, masked pre-selected trauma-related cue images. This condition uses 8 pre-selected trauma-related cue images chosen by the research team to increase category-level cue coverage without requiring participants to provide their own trauma-related material.

  • Patient-provided Trauma-related Cue Images with Eye MovementBehavioural

    After the baseline diary period, participants provide 4 personalized trauma-related cue images. Participants then perform a continuous bilateral eye-movement task while being concurrently exposed to subliminally presented, masked personalized trauma-related cue images provided by themselves. This condition serves as a high-specificity anchor condition while reducing participant burden associated with providing larger numbers of trauma-related images.

  • Neutral Images with Eye MovementBehavioural

    After the baseline diary period, participants perform the same continuous bilateral eye-movement task while being concurrently exposed to subliminally presented, masked pre-selected neutral images unrelated to trauma. This condition uses 8 neutral images and serves as an active control for the general effects of visual stimulation and eye movements while minimizing trauma-related cue activation.

Study groups in NCT07523360
Study groupRoleWhat they receive
Pre-selected Trauma-related Cue Images with Eye MovementExperimentalParticipants assigned to this arm receive the eye-movement intervention with a pre-selected set oftrauma-related cue images prepared by the research team.
Receives: Behavioral: Pre-selected Trauma-related Cue Images with Eye Movement
Patient-provided Trauma-related Cue Images with Eye MovementExperimentalParticipants assigned to this arm receive the eye-movement intervention with 4 personalizedtrauma-related cue images that they provided themselves. This arm serves as a high-specificityanchor condition for evaluating treatment effect magnitude, dropout, and acceptability.
Receives: Behavioral: Patient-provided Trauma-related Cue Images with Eye Movement
Pre-selected Phase-scrambled Images with Eye MovementActive comparatorParticipants assigned to this arm receive the same eye-movement intervention with 8 pre-selectedphase-scrambled images that do not contain identifiable trauma-related semantic content. Thisarm is included to control for the general effects of visual stimulation and eye movements whileminimizing trauma-related cue activation.
Receives: Behavioral: Neutral Images with Eye Movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Intrusive Traumatic Memories

    The number of intrusive memories related to the traumatic event, as recorded by participants in a online diary.

    Measured: Day 66 - 72 (all arms) controlling for baseline week

Secondary outcomes (11)
  1. Number of Intrusive Traumatic Memories

    Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.

    Measured: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week

  2. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    The CAPS-5 is a structured clinical interview assessing the 20 DSM-5 PTSD symptoms. Symptom frequency and intensity are assessed separately but converted into a single 5-point severity scale for each item: 0 (absent), 1 (mild/subthreshold), 2 (moderate/threshold), 3 (severe/markedly elevated), and 4 (extreme/incapacitating). The total severity score is calculated by summing these 20 items, ranging from 0 to 80, with higher scores indicating greater PTSD symptom severity. Furthermore, the CAPS-5 utilizes the SEV2 rule (symptom severity rating of 2 or higher) for diagnostic purposes: a symptom is considered present, and subsequently counted toward a PTSD diagnosis, only if its severity rating is 2 or higher. Conceptually, the SEV2 rule establishes a stringent threshold, generally requiring a minimum symptom frequency of at least twice a month and an intensity of "clearly present".

    Measured: Baseline (day 0) and day 73 (all arms)

  3. Intrusive memory ratings

    This 7-item questionnaire assesses several characteristics of intrusive memories. These characteristics include frequency (7-point categorical response ranging from "never" to "many times a day"); distress (0 = not at all to 10 = extremely); disruption to concentration (0 = not at all to 10 = extremely); interference with ongoing activities, including the degree of interference (0 = not at all to 10 = extremely) and duration of interference (6-point categorical response ranging from less than 1 minute to more than 60 minutes); impact on work functioning (0 = not at all to 10 = extremely); and impact on functioning in other areas of life (0 = not at all to 10 = extremely).

    Measured: Day 24, day 48, day 72, 2 months after the last intervention(all arms)

  4. Post-Intervention Questionnaire

    A 2-item questionnaire assessed participants' immediate subjective experience after each intervention session: distress experienced during the procedure, rated from 0 (not at all distressing) to 10 (very distressing), and acceptability of the intervention task, rated from 0 (not at all acceptable) to 10 (very acceptable).

    Measured: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)

  5. Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    The PCL-5 is a 20-item self-report questionnaire that assesses the presence and severity of PTSD symptoms experienced in the past month. Each of the 20 items is rated on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). The total symptom severity score is calculated by summing the scores of all 20 items. The total score ranges from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. (Note: A 5-point change represents a minimum threshold for treatment response, and a 10-point change indicates a clinically meaningful improvement).

    Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  6. Impact of Event Scale-Revised (IES-R)

    The IES-R is a 22-item self-report questionnaire designed to measure subjective distress caused by traumatic events during the past seven days. It assesses three domains of post-traumatic stress: intrusion, avoidance, and hyperarousal. Each of the 22 items is rated on a 5-point scale according to symptom severity: 0 (Not at all), 1 (A little bit), 2 (Moderately), 3 (Quite a bit), and 4 (Extremely). The total score is calculated by summing the scores of all 22 items, yielding a total score range from 0 to 88. Lower scores indicate less distress, while higher scores indicate more severe post-traumatic stress symptoms. A total score of 33 or over signifies the likely presence of PTSD.

    Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  7. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to assess the existence and severity of depressive symptoms, covering emotional (e.g., sadness, hopelessness), cognitive (e.g., self-reproach, worthlessness), somatic (e.g., fatigue, appetite loss), and behavioral (e.g., loss of interest, social withdrawal) dimensions. Each of the 21 items consists of four statements describing increasing levels of severity, rated on a 4-point scale ranging from 0 (not present) to 3 (severe). The total score is calculated by summing the scores of all 21 items, with a total score range from 0 to 63. Higher scores indicate more severe depressive symptoms.

    Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  8. State-Trait Anxiety Inventory - State Anxiety (STAI-S)

    The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-Form Y-I, S-AI) comprises items 1 to 20 of the inventory. Half of the items describe negative emotions and the other half describe positive emotions. It is designed to evaluate immediate or recent situational experiences of fear, tension, worry, and nervousness, making it particularly useful for assessing state anxiety under stressful conditions. Each of the 20 items is rated on a 4-point scale: 1 (not at all), 2 (somewhat), 3 (moderately so), and 4 (very much so). The S-AI total score is calculated by summing the 20 items, yielding a total score range from 20 to 80. Higher scores reflect a greater severity of the subject's current state anxiety symptoms.

    Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  9. Work and Social Adjustment Scale (WSAS)

    The Work and Social Adjustment Scale (WSAS) is a 5-item self-report scale designed to measure the degree of functional impairment in day-to-day activities, including work, home management, social leisure activities, private leisure activities, and close relationships. Each of the 5 items is rated on a 9-point scale ranging from 0 (not at all impaired) to 8 (very severely impaired). The total score is calculated by summing the scores of all 5 items, yielding a total score ranging from 0 to 40. Lower scores indicate better functioning, whereas higher scores indicate greater functional impairment. Clinical thresholds are as follows: below 10 (subclinical), 10 to 20 (significant functional impairment), and above 20 (moderately severe or worse psychopathology).

    Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  10. Borderline Symptom List 23 (BSL-23)

    The Borderline Symptom List-23 (BSL-23) is a 23-item self-report instrument designed to assess the severity of borderline personality disorder symptomatology over the past week, based on the criteria established by Bohus et al. (2009). Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very strong"). The total score is calculated as the mean of all valid items (sum of item scores divided by the number of answered items). The resulting score ranges from 0.0 to 4.0, with higher scores indicating greater severity of borderline symptoms. In addition, the scale includes a visual analog scale (VAS) to assess the participant's overall personal state during the past week. This scale ranges from 0% (absolutely down) to 100% (excellent) and is recorded as a supplementary indicator.

    Measured: Baseline (day 0) and day 73 (all arms)

  11. Number of Intrusive Traumatic Memories

    Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.

    Measured: Day 1-7 (all arms) before intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start10 Jun 2026
  3. Primary completion10 Apr 2028 (estimated)
  4. Study completion10 Jul 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07523360
Sponsor's protocol ID
PTSDPIC20260309
Status last verified
Aug 2026
First submitted
4 Apr 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Study Protocol and Statistical Analysis Plan will be shared on the Open Science Framework, together with an anonymised database of individual participant data, data dictionary, and analysis scripts.

Questions about this trial

What is this clinical trial studying?

A study testing Pre-selected Trauma-related Cue Images with Eye Movement, Patient-provided Trauma-related Cue Images with Eye Movement and Neutral Images with Eye Movement in people with Post-Traumatic Stress Disorder (PTSD) and Intrusive Memories of Traumatic Event(s), run by Zhu Zijian at 1 site in China.

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 4 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 2 Sep 2026. 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 China. 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. 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 Zijian Zhu (+86 13572494696, zhuzijian0203@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Intrusive Traumatic Memories (time frame: Day 66 - 72 (all arms) controlling for baseline week). 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 2 Sep 2026.

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