A Digital Cognitive Intervention for Intrusive Memories After Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorZhu Zijian
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for post-traumatic stress disorder (PTSD), which requires exposure to an event involving serious injury or a threat to one's own or another person's physical well-being, either through direct experience or witnessing.
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).
Have a total score of 33 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Have internet access and access to a personal computer.
Disqualifiers
Fewer than 5 intrusive memories during the baseline week (Week 0).
An intelligence quotient (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.
Severe substance dependence.
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-selected Trauma-related Cue Images with Eye Movement
BehavioralAfter 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
BehavioralAfter 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
BehavioralAfter 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.
Treatment groups
123 Participants
are divided into 3 treatment groupsGroup A: Pre-selected Trauma-related Cue Images with Eye MovementExperimental treatment 1 intervention
Group B: Patient-provided Trauma-related Cue Images with Eye MovementExperimental treatment 1 intervention
Group C: Pre-selected Phase-scrambled Images with Eye MovementActive comparator 1 intervention
Trial outcomes
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.
Time frame
Day 66 - 72 (all arms) controlling for baseline weekSecondary outcomes
1
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.
Time frame
Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week2
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 (symptom severity rating of 2 or higher) 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".
Time frame
Baseline (day 0) and day 73 (all arms)3
Intrusive memory ratings
This 7-item questionnaire assesses several characteristics of intrusive memories. These characteristics include frequency (7-point categorical response ranging 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 ongoing activities, including the degree of interference (0 = not at all to 10 = extremely) and duration of interference (6-point categorical response ranging from less than 1 minute to more than 60 minutes); impact on work functioning (0 = not at all to 10 = extremely); and impact on functioning in other areas of life (0 = not at all to 10 = extremely).
Time frame
Day 24, day 48, day 72, 2 months after the last intervention(all arms)4
Post-Intervention Questionnaire
A 2-item questionnaire assessed participants' immediate subjective experience after each intervention session: distress experienced during the procedure, rated from 0 (not at all distressing) to 10 (very distressing), and acceptability of the intervention task, rated from 0 (not at all acceptable) to 10 (very acceptable).
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)Other outcomes
1
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.
Time frame
Day73 and 2 months after the last intervention(all arms)2
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.
Time frame
Day65 (all arms)3
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a single item.
Time frame
2 months after the last intervention (all arms)4
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.
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65(all arms)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhu Zijian
Lead sponsor
Shaanxi Normal University
Sponsor institution
Source ClinicalTrials.gov