A Digital Cognitive Intervention for Intrusive Memories After Trauma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Number of Intrusive Traumatic Memories — 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.

Trial sites (1)

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