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Not Yet RecruitingNCT07523360

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
123 (estimated)
Sponsor
Zhu Zijian · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPre-selected Trauma-related Cue Images with Eye MovementAfter 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.
BEHAVIORALPatient-provided Trauma-related Cue Images with Eye MovementAfter 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.
BEHAVIORALNeutral Images with Eye MovementAfter 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.

Timeline

Start date
2026-04-10
Primary completion
2028-02-10
Completion
2028-05-10
First posted
2026-04-13
Last updated
2026-04-13

Source: ClinicalTrials.gov record NCT07523360. Inclusion in this directory is not an endorsement.