A Digital Cognitive Intervention for Intrusive Memories After Trauma

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Traumatic Stress Disorder (PTSD); Intrusive Memories of Traumatic Event(s)
• Intervention / Treatment: Behavioral: Pre-selected Trauma-related Cue Images with Eye Movement; Behavioral: Patient-provided Trauma-related Cue Images with Eye Movement; Behavioral: Neutral Images with Eye Movement

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.

• Study Type: Interventional
• Enrollment (Estimated): 123
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zijian Zhu; Phone Number: +86 13572494696; Email: zhuzijian0203@snnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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).
3. The total score of CAPS-5 ≥ 33.
4. Have internet access and have access to a personal computer.
5. Have not taken part in a previous study of this intervention from this research team.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-selected Trauma-related Cue Images with Eye Movement; Participants assigned to this arm receive the eye-movement intervention with 8 pre-selected trauma-related cue images.	Behavioral: Pre-selected Trauma-related Cue Images with Eye Movement; 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.
Experimental: Patient-provided Trauma-related Cue Images with Eye Movement; Participants assigned to this arm receive the eye-movement intervention with 4 personalized trauma-related cue images that they provided themselves. This arm serves as a high-specificity anchor condition for evaluating treatment effect magnitude, dropout, and acceptability.	Behavioral: Patient-provided Trauma-related Cue Images with Eye Movement; 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.
Active Comparator: Neutral Images with Eye Movement; Participants assigned to this arm receive the same eye-movement intervention with 8 neutral images unrelated to trauma. This arm is included to control for the general effects of visual stimulation and eye movements in the absence of trauma-related cue activation.	Behavioral: Neutral Images with Eye Movement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Intrusive Traumatic Memories	The number of intrusive memories related to the traumatic event, as recorded by participants in a online diary.	Day 66 - 72 (all arms) controlling for baseline week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Work and Social Adjustment Scale (WSAS)	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).	Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Intrusive memory ratings	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).	Day 24, day 48, day 72, 2 months after the last intervention(all arms)
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.	Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week
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 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".	Baseline (day 0) and day 73 (all arms)
Post-Intervention Questionnaire	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	Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)
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).	Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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.	Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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.	Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Borderline Symptom List 23 (BSL-23)	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.	Baseline (day 0) and day 73 (all arms)
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.	Day 1-7 (all arms) before intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to health	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.	Day73 and 2 months after the last intervention(all arms)
Feedback questionnaire	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.	Day65 (all arms)
Number of trauma-related intrusive memories	Number of trauma-related intrusive memories assessed via a single item.	2 months after the last intervention (all arms)
Subliminal Perception Check	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.	Day1, 9, 17, 25, 33, 41, 49, 57, 65(all arms)

Collaborators and Investigators

• Sponsor: Zhu Zijian

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): May 10, 2028

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Eye Movements
• Other Study ID Numbers: PTSDPIC20260309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing Time Frame

The Study Protocol and Statistical Analysis Plan were uploaded to the Open Science Framework (OSF) prior to the last participant completing the last visit.

Results of the study will be shared through open access publications. On publication of the main study results, the associated database of individual participant data (anonymised), data dictionary, and analysis scripts will be made available on OSF.

The information described above will be shared indefinitely and with no end date on the OSF platform.

IPD Sharing Access Criteria

The information described above will be made available on the OSF indefinitely.

OSF is an open source web application that is freely accessible to the public and scientific community.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No