A Digital Cognitive Intervention for Intrusive Memories After Trauma

Official title

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

Overview

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.

Interventions

• 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.
• 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.
• 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.

Primary outcome measures

• Number of Intrusive Traumatic Memories [Time frame: Day 66 - 72 (all arms) controlling for baseline week]

Secondary outcome measures (11)

• Number of Intrusive Traumatic Memories [Time frame: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: Baseline (day 0) and day 73 (all arms)]
• Intrusive memory ratings [Time frame: Day 24, day 48, day 72, 2 months after the last intervention(all arms)]
• Post-Intervention Questionnaire [Time frame: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)]
• 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)]
• Impact of Event Scale-Revised (IES-R) [Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Beck Depression Inventory-II (BDI-II) [Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• State-Trait Anxiety Inventory - State Anxiety (STAI-S) [Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Work and Social Adjustment Scale (WSAS) [Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Borderline Symptom List 23 (BSL-23) [Time frame: Baseline (day 0) and day 73 (all arms)]
• Number of Intrusive Traumatic Memories [Time frame: Day 1-7 (all arms) before intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07523360 · PTSDPIC20260309

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗