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NCT07523360
A Digital Cognitive Intervention for Intrusive Memories After Trauma
Conditions: Post-Traumatic Stress Disorder (PTSD), Intrusive Memories of Traumatic Event(s)
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 123
Sponsor: Zhu Zijian
Location: School of Psychology, Shaanxi Normal University Xi'an Shaanxi
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 Criteria
Inclusion Criteria:
1. 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.
2. 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).
3. Have a total score of 33 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
4. Have internet access and access to a personal computer.
5. Have not taken part in a previous study of this intervention conducted by this research team.
Exclusion Criteria:
1. Fewer than 5 intrusive memories during the baseline week (Week 0).
2. An intelligence quotient (IQ) score lower than 80.
3. A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior.
4. Severe substance dependence.
Source: ClinicalTrials.gov (NCT07523360). StuddyBuddy aggregates publicly available trial information.