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Post-Traumatic Stress Disorder (PTSD) is characterized by recurrent, intrusive memories of traumatic events that cause significant distress and functional impairment. Although trauma-focused treatments are effective, they typically require deliberate recollection of traumatic experiences, which can be distressing and may contribute to treatment avoidance or dropout.
In previous experimental studies conducted with healthy participants, we demonstrated that unconscious reactivation of trauma-related cues, followed-after a brief delay corresponding to the memory reconsolidation window-by a visuospatial interference task (Tetris gameplay), reduced the frequency and emotional intensity of intrusive memories. These findings suggest that memory representations may be modifiable during reconsolidation without requiring conscious recall.
Building on this work, the present randomized controlled trial (RCT) aims to evaluate the clinical efficacy and tolerability of this reconsolidation-based intervention in trauma-exposed individuals experiencing five or more intrusive memories per week.
This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results. Before recording the baseline diary, each participant will need to provide four images related to their trauma experience for use in subsequent experiments.The provision of these images is voluntary, and participants are fully informed of the intended use of their images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unconscious Reactivation | Experimental | Participants in this experimental arm will undergo subliminal (unconscious) reactivation of trauma-related memories. Trauma cues are presented strictly below the threshold of conscious awareness to minimize psychological distress, while theoretically aiming to trigger the destabilization of the target memory. |
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| No Reactivation Control | Sham Comparator | Participants in this control arm will not undergo trauma memory reactivation. This condition is designed as a sham comparator to match the overall timing and structure of the experimental arms, isolating the specific effect of memory reactivation and controlling for the nonspecific effects of task engagement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subliminal Reactivation | Behavioral | In each intervention session, participants are exposed subliminally to trauma-related cues and then complete a computerized visuospatial task (Tetris) with mental rotation instructions. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of trauma-related intrusive memories | Number of trauma-related intrusive memories assessed via a daily diary. | Day 66 - 72(all arms) controlling for baseline week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of trauma-related intrusive memories | Number of trauma-related intrusive memories assessed via a daily diary. | Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day73 and 2 months after the last intervention(all arms) |
| Feedback questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Zijian | Contact | +86 13572494696 | zhuzijian0203@snnu.edu.cn |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Computer-based Visuospatial Task (Tetris) | Behavioral | A computerized visuospatial task (Tetris) with mental rotation instructions. |
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Change in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The combined score for each individual symptom (referred to as the "symptom score") is the sum of the frequency rating (0=Absent to 4=Extreme / incapacitating) and the intensity rating (0=Absent to 4=Extreme / incapacitating), ranging from 0 to 8. The total score of the CAPS-5 is the sum of the symptom scores for the 20 symptom items, ranging from 0 to 160 (20 items × 8 points). A higher total score indicates greater overall severity of PTSD symptoms. A score of 0-19 indicates no symptoms, 20-39 indicates mild, 40-59 indicates moderate, 60-79 indicates severe, and 80 or above indicates extremely severe. Additionally, the diagnosis of CAPS-5 is not based solely on the total score; it must also meet the symptom cluster criteria of DSM-5.
| 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). | 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 (0=not at all to 10=very). | Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms) |
| PTSD Checklist for DSM-5 (PCL-5) | This 20-item measure assesses symptoms of PTSD over the last 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 score ranges from 0 to 80. | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) |
| Impact of Event Scale-Revised (IES-R) | This 22-item self-report 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) to 4 (Extremely). The total score is calculated by summing the scores of all 22 items, yielding a total score range from 0 to 88. | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) |
| Beck Depression Inventory-II (BDI-II) | 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. | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) |
| State-Trait Anxiety Inventory-State version (STAI-S) | 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 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. | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) |
| Work and Social Adjustment Scale (WSAS) | The WSAS is a 5-item self-report scale designed to measure the degree of functional impairment in day-to-day activities (work, home management, social leisure, private leisure, 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 range from 0 to 40. Lower scores indicate better functioning, while higher scores indicate greater functional impairment. Clinical thresholds are: below 10 (subclinical), 10 to 20 (significant functional impairment), and above 20 (moderately severe or worse psychopathology). | Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms) |
A 5-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; willingness to recommend the intervention to others with similar intrusive memories; whether they perceived the task as related to their condition during the experiment. |
| Day65 (all arms) |
| Number of trauma-related intrusive memories | Number of trauma-related intrusive memories assessed via a single item . | 2 months after the last intervention (all arms) |
| Subliminal Perception Check | Administered only to the unconscious cue group; following 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. | Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only) |