A Digital Cognitive Intervention for Intrusive Memories After Trauma

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorZhu Zijian

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

123 Participants

are divided into 3 treatment groups

Group 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: Neutral Images with Eye MovementActive comparator 1 intervention

Trial outcomes

Primary outcomes

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 week

Secondary outcomes

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 week

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 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)

Intrusive memory ratings

This 7-item questionnaire assesses a number of intrusive memory characteristics. These characteristics include: frequency (7-point categorical response 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 what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '\<1min' to '\>60mins')); impact on work functioning (0=not at all to 10=extremely); 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)

Post-Intervention Questionnaire

A 2-item questionnaire assessed participants' immediate subjective experience after each intervention session: distress experienced during the procedure (0=not at all to 10=very); acceptability of the intervention task

Time frame

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

Other outcomes

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)

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)

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)

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)

Locations

This trial has no locations.

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

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