Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

• Have not taken part in a previous study of this intervention conducted by this research team.

Locations
Other Locations
China
School of Psychology, Shaanxi Normal University
RECRUITING
Xi'an
Contact Information
Primary
Zijian Zhu
zhuzijian0203@snnu.edu.cn
+86 13572494696
Time Frame
Start Date: 2026-06-10
Estimated Completion Date: 2028-07-10
Participants
Target number of participants: 123
Treatments
Experimental: Pre-selected Trauma-related Cue Images with Eye Movement
Participants assigned to this arm receive the eye-movement intervention with a pre-selected set oftrauma-related cue images prepared by the research team.
Experimental: Patient-provided Trauma-related Cue Images with Eye Movement
Participants assigned to this arm receive the eye-movement intervention with 4 personalizedtrauma-related cue images that they provided themselves. This arm serves as a high-specificityanchor condition for evaluating treatment effect magnitude, dropout, and acceptability.
Active_comparator: Pre-selected Phase-scrambled Images with Eye Movement
Participants assigned to this arm receive the same eye-movement intervention with 8 pre-selectedphase-scrambled images that do not contain identifiable trauma-related semantic content. Thisarm is included to control for the general effects of visual stimulation and eye movements whileminimizing trauma-related cue activation.
Related Therapeutic Areas
Sponsors
Leads: Zhu Zijian

This content was sourced from clinicaltrials.gov