Unconscious Trauma Reactivation plus Eye Movements
BehavioralParticipants will complete a procedure involving unconscious activation combined with eye movements.
NCT Number: NCT07767396
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete a procedure involving unconscious activation combined with eye movements.
Participants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements.
Participants will complete a standardized procedure involving recall of a neutral memory combined with eye movements.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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).
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.
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.
Time frame: 2 months after the last intervention (all arms)
Number of trauma-related intrusive memories assessed via a single item.
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.
Contact information is provided by the study sponsor or research team.
Shaanxi Normal University
Other
The Effects of Different Memory Reactivation Procedures Combined With Bilateral Eye Movements on Intrusive Memories and PTSD Symptoms: A Three-Arm Randomized Controlled Trial
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