A Digital Cognitive Intervention for Intrusive Memories After Trauma

NCT07523360 | Not Yet Recruiting

• 1 other identifier: PTSDPIC20260309
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post-Traumatic Stress Disorder (PTSD); Intrusive Memories of Traumatic Event(s)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of Intrusive Traumatic Memories

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

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Baseline (day 0) and day 73 (all arms)

• Intrusive memory ratings

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

• Post-Intervention Questionnaire

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

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

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

Other Outcomes (4)

• Changes to health

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

• Feedback questionnaire

  Day65 (all arms)

• Number of trauma-related intrusive memories

  2 months after the last intervention (all arms)

Study Arms (3)

Pre-selected Trauma-related Cue Images with Eye Movement

EXPERIMENTAL

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

Patient-provided Trauma-related Cue Images with Eye Movement

EXPERIMENTAL

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

Neutral Images with Eye Movement

ACTIVE COMPARATOR

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

Interventions

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.

Pre-selected Trauma-related Cue Images with Eye Movement

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.

Patient-provided Trauma-related Cue Images with Eye Movement

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.

Neutral Images with Eye Movement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhu Zijian: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movements

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Central Study Contacts

Zijian Zhu

CONTACT

+86 13572494696; zhuzijian0203@snnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): May 10, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.