Intrusive Memories of Traumatic Event(s), Post-Traumatic Stress Disorder (PTSD)
Conditions
Brief 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.
Detailed description
This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results.
Interventions
BEHAVIORALPre-selected Trauma-related Cue Images with Eye Movement
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.
BEHAVIORALPatient-provided Trauma-related Cue Images with Eye Movement
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.
BEHAVIORALNeutral Images with Eye Movement
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.
Sponsors
Zhu Zijian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intrusive Traumatic Memories | Day 66 - 72 (all arms) controlling for baseline week | The number of intrusive memories related to the traumatic event, as recorded by participants in a online diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intrusive Traumatic Memories | Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days. |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline (day 0) and day 73 (all arms) | 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". |
| Intrusive memory ratings | Day 24, day 48, day 72, 2 months after the last intervention(all arms) | 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). |
| Post-Intervention Questionnaire | Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms) | 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). |
| Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) | The PCL-5 is a 20-item self-report questionnaire that assesses the presence and severity of PTSD symptoms experienced in the past month. Each of the 20 items is rated on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). The total symptom severity score is calculated by summing the scores of all 20 items. The total score ranges from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. (Note: A 5-point change represents a minimum threshold for treatment response, and a 10-point change indicates a clinically meaningful improvement). |
| Impact of Event Scale-Revised (IES-R) | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) | The IES-R is a 22-item self-report questionnaire designed to measure subjective distress caused by traumatic events during the past seven days. It assesses three domains of post-traumatic stress: intrusion, avoidance, and hyperarousal. Each of the 22 items is rated on a 5-point scale according to symptom severity: 0 (Not at all), 1 (A little bit), 2 (Moderately), 3 (Quite a bit), and 4 (Extremely). The total score is calculated by summing the scores of all 22 items, yielding a total score range from 0 to 88. Lower scores indicate less distress, while higher scores indicate more severe post-traumatic stress symptoms. A total score of 33 or over signifies the likely presence of PTSD. |
| Beck Depression Inventory-II (BDI-II) | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) | The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to assess the existence and severity of depressive symptoms, covering emotional (e.g., sadness, hopelessness), cognitive (e.g., self-reproach, worthlessness), somatic (e.g., fatigue, appetite loss), and behavioral (e.g., loss of interest, social withdrawal) dimensions. Each of the 21 items consists of four statements describing increasing levels of severity, rated on a 4-point scale ranging from 0 (not present) to 3 (severe). The total score is calculated by summing the scores of all 21 items, with a total score range from 0 to 63. Higher scores indicate more severe depressive symptoms. |
| State-Trait Anxiety Inventory - State Anxiety (STAI-S) | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) | The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-Form Y-I, S-AI) comprises items 1 to 20 of the inventory. Half of the items describe negative emotions and the other half describe positive emotions. It is designed to evaluate immediate or recent situational experiences of fear, tension, worry, and nervousness, making it particularly useful for assessing state anxiety under stressful conditions. Each of the 20 items is rated on a 4-point scale: 1 (not at all), 2 (somewhat), 3 (moderately so), and 4 (very much so). The S-AI total score is calculated by summing the 20 items, yielding a total score range from 20 to 80. Higher scores reflect a greater severity of the subject's current state anxiety symptoms. |
| Work and Social Adjustment Scale (WSAS) | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) | The Work and Social Adjustment Scale (WSAS) is a 5-item self-report scale designed to measure the degree of functional impairment in day-to-day activities, including work, home management, social leisure activities, private leisure activities, and close relationships. Each of the 5 items is rated on a 9-point scale ranging from 0 (not at all impaired) to 8 (very severely impaired). The total score is calculated by summing the scores of all 5 items, yielding a total score ranging from 0 to 40. Lower scores indicate better functioning, whereas higher scores indicate greater functional impairment. Clinical thresholds are as follows: below 10 (subclinical), 10 to 20 (significant functional impairment), and above 20 (moderately severe or worse psychopathology). |
| Borderline Symptom List 23 (BSL-23) | Baseline (day 0) and day 73 (all arms) | The Borderline Symptom List-23 (BSL-23) is a 23-item self-report instrument designed to assess the severity of borderline personality disorder symptomatology over the past week, based on the criteria established by Bohus et al. (2009). Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very strong"). The total score is calculated as the mean of all valid items (sum of item scores divided by the number of answered items). The resulting score ranges from 0.0 to 4.0, with higher scores indicating greater severity of borderline symptoms. In addition, the scale includes a visual analog scale (VAS) to assess the participant's overall personal state during the past week. This scale ranges from 0% (absolutely down) to 100% (excellent) and is recorded as a supplementary indicator. |
Countries
China
Contacts
CONTACTZijian Zhu
Outcome results
None listed