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NCT Number: NCT07523360

A Digital Cognitive Intervention for Intrusive Memories After Trauma

Intrusive traumatic memories frequently trigger severe distress and psychological disorders like PTSD. Traditional therapies require explicit trauma recall, which often causes severe patient distress and leads to treatment avoidance. To address this, our study introduces a novel, less aversive intervention combining unconscious visual processing with bilateral eye movement to mitigate these intrusive memories.

Utilizing a randomized, three-arm design (comparing 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 ≥ 5 intrusive memories weekly, targeting a final sample of 40 patients per arm. The primary outcome is the frequency of intrusive memories. Secondary and additional outcomes include PTSD severity (CAPS-5, PCL-5, IES), depression, anxiety, borderline symptoms, functional improvements, subjective intervention distress, and dropout rates.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet DSM-5 Criterion A for PTSD, which stipulates exposure to an event involving serious injury or a threat to one's own or another's physical well-being, either through direct experience or witnessing.
  • Participants needed to 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).
  • The total score of CAPS-5 ≥ 33.
  • Have internet access and have access to a personal computer.
  • Have not taken part in a previous study of this intervention from this research team.

Exclusion criteria

  • Fewer than 5 intrusive memories during the baseline week (Week 0).
  • 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.
  • Have severe substance dependence.

Treatment and study plan

Pre-selected Trauma-related Cue Images with Eye Movement

Behavioral

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 Movement

Behavioral

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 Movement

Behavioral

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.

Primary outcomes

  1. Number of Intrusive Traumatic Memories

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

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

Secondary outcomes

  1. Number of Intrusive Traumatic Memories

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

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

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

    Time frame: Baseline (day 0) and day 73 (all arms)

    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 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".

  3. Intrusive memory ratings

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

    This 7-item questionnaire assesses a number of intrusive memory characteristics. These characteristics include: frequency (7-point categorical response 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 what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '>60mins')); impact on work functioning (0=not at all to 10=extremely); impact on functioning in other areas of life (0=not at all to 10=extremely).

  4. Post-Intervention Questionnaire

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

    A 2-item questionnaire assessed participants' immediate subjective experience after each intervention session: distress experienced during the procedure (0=not at all to 10=very); acceptability of the intervention task

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

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

    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).

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

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

    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.

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

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

    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.

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

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

    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.

  9. Work and Social Adjustment Scale (WSAS)

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

    The WSAS is a 5-item self-report scale designed to measure the degree of functional impairment in day-to-day activities (work, home management, social leisure, private leisure, 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 range from 0 to 40. Lower scores indicate better functioning, while higher scores indicate greater functional impairment. Clinical thresholds are: below 10 (subclinical), 10 to 20 (significant functional impairment), and above 20 (moderately severe or worse psychopathology).

  10. Borderline Symptom List 23 (BSL-23)

    Time frame: Baseline (day 0) and day 73 (all arms)

    The 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 score is calculated as the mean of all valid items (sum of scores divided by the number of answered items). The resulting score ranges from 0.0 to 4.0, where higher scores indicate a greater severity of borderline symptoms. Additionally, the scale includes a visual analog scale (VAS) to assess the participant's overall personal state during the past week, ranging from 0% (absolutely down) to 100% (excellent), which is recorded as a supplementary indicator.

  11. Number of Intrusive Traumatic Memories

    Time frame: Day 1-7 (all arms) before intervention

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

Other outcomes

  1. Changes to health

    Time frame: Day73 and 2 months after the last intervention(all arms)

    This 4-item questionnaire assesses the number of any new traumatic events, new treatments received and the occurrence of adverse events since the last assessment.

  2. Feedback questionnaire

    Time frame: Day65 (all arms)

    A 4-item questionnaire (0=not at all to 10=very) assessed participants' subjective experience of the intervention: ease of use; perceived helpfulness; willingness to use the intervention if intrusive memories recur in the future; whether they perceived the task as related to their condition during the experiment.

  3. Number of trauma-related intrusive memories

    Time frame: 2 months after the last intervention (all arms)

    Number of trauma-related intrusive memories assessed via a single item.

  4. Subliminal Perception Check

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

    At each intervention, participants are asked whether they perceived any image via a single-item binary choice (Yes/No). If the response is "Yes," an open-ended verbal description is required.

Study contacts

Contact information is provided by the study sponsor or research team.

Zijian Zhu

CONTACT

[email protected]

+86 13572494696

Sponsors and collaborators

Lead sponsor

Zhu Zijian

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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