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NCT Number: NCT07767396

Eye Movement Intervention With Different Memory Reactivation Procedures for Intrusive Traumatic Memories

Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) may be effective, they often involve engagement with trauma-related memories, which can be distressing for some individuals and may affect treatment acceptability. This randomized controlled trial will evaluate a standardized eye-movement-based procedure for trauma-exposed individuals experiencing recurrent intrusive memories. Participants will be randomly assigned to one of several memory-related task conditions involving eye movements. The study will assess the frequency and distress of trauma-related intrusive memories at prespecified assessment points, as well as PTSD symptoms, intervention-related distress, acceptability, and safety. Findings from this trial may help inform the development of tolerable approaches for targeting trauma-related intrusive memories.

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Key information

About this study

  • This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results.
  • Participants randomized to the Active Trauma Recall + Eye Movements condition who explicitly indicate, after receiving a detailed explanation and before initiating the active trauma recall procedure, that they are unable or unwilling to proceed will be recorded as having discontinued the assigned RCT intervention/procedure. The timing and reason for discontinuation will be documented. These participants will not be re-randomized or reassigned to another RCT condition, and their available data will be handled according to the pre-specified analysis population and missing-data procedures of the main RCT.

Any optional exploratory follow-up conducted after discontinuation will be independent of the main RCT and will be used only to collect descriptive feasibility, safety, and acceptability information. Data from such follow-up will not be included in the primary or secondary efficacy analyses of the main RCT and, if reported, will be presented separately from the RCT outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet DSM-5 PTSD Criterion A, such as exposure to actual or threatened death, serious injury, or sexual violence; have experienced one or more traumatic events.
  • Experienced five or more trauma-related intrusive memories during the baseline week.
  • Have internet access and access to a personal computer suitable for completing the online study tasks.
  • Have normal or corrected-to-normal vision and be able to complete computerized visual and eye movement tasks.
  • Be willing to provide informed consent, able to complete study procedures, and able to be contacted by the study team.

Exclusion criteria

  • Have fewer than five trauma-related intrusive memories during the baseline week.
  • Have a current or past psychotic disorder, current manic episode, severe obsessive-compulsive disorder, severe personality disorder, or another severe psychiatric condition judged to interfere with study participation, adherence, or safety.
  • Have current acute suicidal ideation or behavior, significant risk of harm to self or others, or any condition requiring urgent clinical intervention.
  • Have current severe substance use disorder or severe substance dependence judged to interfere with study participation or safety.
  • Have a current organic disorder, neurological condition, history of epilepsy or seizures, significant brain injury, or other medical condition judged to interfere with safe participation or completion of the computerized visual or eye movement tasks.
  • Have visual impairment or other condition that prevents completion of the computerized visual or eye movement tasks.
  • Current participation in another intervention study or current treatment judged by the research team to interfere with study participation, safety, or outcome assessment.

Treatment and study plan

Unconscious Trauma Reactivation plus Eye Movements

Behavioral

Participants will complete a procedure involving unconscious activation combined with eye movements.

Active Trauma Memory Reactivation plus Eye Movements

Behavioral

Participants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements.

Neutral Memory Reactivation plus Eye Movements

Behavioral

Participants will complete a standardized procedure involving recall of a neutral memory combined with eye movements.

Primary outcomes

  1. Number of trauma-related intrusive memories

    Time frame: Day 66 - 72(all arms) controlling for baseline week

    Total number of trauma-related intrusive memories recorded in a daily diary over the 7-day assessment period.

Secondary outcomes

  1. Number of trauma-related intrusive memories

    Time frame: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week

    Number of trauma-related intrusive memories assessed via a daily diary.

  2. Intrusive memory ratings

    Time frame: Baseline(day 0), day 24, day 48, day 72, 2 months after the last intervention(all arms)

    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).

  3. Post-Intervention Questionnaire

    Time frame: 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 (0=not at all to 10=very); acceptability of the intervention task (0=not at all to 10=very).

  4. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

    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.

  5. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Baseline (day 0) and day 73 (all arms)

    Change in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured clinical interview assessing DSM-5 PTSD symptoms. Each of the 20 PTSD symptom items is rated on a severity scale from 0 to 4. The total symptom severity score is calculated by summing the severity ratings for the 20 PTSD symptom items, yielding a total score range from 0 to 80. Higher scores indicate greater PTSD symptom severity. PTSD diagnostic status is determined according to DSM-5 symptom cluster criteria and is not based solely on the total severity score.

  6. Impact of Event Scale-Revised (IES-R)

    Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

    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.

  7. Beck Depression Inventory-II (BDI-II)

    Time frame: 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.

  8. State-Trait Anxiety Inventory-State version (STAI-S)

    Time frame: 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 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.

  9. Work and Social Adjustment Scale (WSAS)

    Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

    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).

Other outcomes

  1. Changes to health

    Time frame: Day73 and 2 months after the last intervention(all arms)

    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.

  2. Feedback questionnaire

    Time frame: Day65 (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.

  3. Number of trauma-related intrusive memories

    Time frame: 2 months after the last intervention (all arms)

    Number of trauma-related intrusive memories assessed via a single item.

  4. Subliminal Perception Check

    Time frame: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only)

    Administered only to the unconscious trauma cue group. Following each intervention session, participants will be asked whether they perceived any image using a single-item binary choice (Yes/No). If the response is "Yes," participants will be asked to provide an open-ended description.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhu Zijian

CONTACT

[email protected]

+86 13572494696

Sponsors and collaborators

Lead sponsor

Shaanxi Normal University

Other

Registry information

Official study title

The Effects of Different Memory Reactivation Procedures Combined With Bilateral Eye Movements on Intrusive Memories and PTSD Symptoms: A Three-Arm Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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