A Digital Cognitive Intervention for Intrusive Memories After Trauma

Официальное название

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

Обзор

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.

Подробное описание

This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results.

Вмешательства

• Поведенческое Pre-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.
• Поведенческое Patient-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.
• Поведенческое Neutral 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.

Первичные конечные точки

• Number of Intrusive Traumatic Memories [Срок оценки: Day 66 - 72 (all arms) controlling for baseline week]

Вторичные конечные точки (11)

• Number of Intrusive Traumatic Memories [Срок оценки: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Baseline (day 0) and day 73 (all arms)]
• Intrusive memory ratings [Срок оценки: Day 24, day 48, day 72, 2 months after the last intervention(all arms)]
• Post-Intervention Questionnaire [Срок оценки: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)]
• Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Impact of Event Scale-Revised (IES-R) [Срок оценки: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Beck Depression Inventory-II (BDI-II) [Срок оценки: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• State-Trait Anxiety Inventory - State Anxiety (STAI-S) [Срок оценки: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Work and Social Adjustment Scale (WSAS) [Срок оценки: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)]
• Borderline Symptom List 23 (BSL-23) [Срок оценки: Baseline (day 0) and day 73 (all arms)]
• Number of Intrusive Traumatic Memories [Срок оценки: Day 1-7 (all arms) before intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07523360 · PTSDPIC20260309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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