Eye Movement Intervention With Different Memory Reactivation Procedures for Intrusive Traumatic Memories
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShaanxi Normal University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Unconscious Trauma Reactivation plus Eye Movements
BehavioralParticipants will complete a procedure involving unconscious activation combined with eye movements.
Active Trauma Memory Reactivation plus Eye Movements
BehavioralParticipants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements.
Neutral Memory Reactivation plus Eye Movements
BehavioralParticipants will complete a standardized procedure involving recall of a neutral memory combined with eye movements.
Treatment groups
117 Participants
are divided into 3 treatment groupsGroup A: Unconscious Trauma-Related Visual Processing plus Eye MovementsExperimental treatment 1 intervention
Group B: Active Trauma Recall plus Eye MovementsActive comparator 1 intervention
Group C: Neutral Memory Reactivation plus Eye MovementsSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of trauma-related intrusive memories
Total number of trauma-related intrusive memories recorded in a daily diary over the 7-day assessment period.
Time frame
Day 66 - 72(all arms) controlling for baseline weekSecondary outcomes
1
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a daily diary.
Time frame
Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week2
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).
Time frame
Baseline(day 0), day 24, day 48, day 72, 2 months after the last intervention(all arms)3
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).
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)4
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.
Time frame
Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)Other outcomes
1
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.
Time frame
Day73 and 2 months after the last intervention(all arms)2
Feedback questionnaire
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
Day65 (all arms)3
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a single item.
Time frame
2 months after the last intervention (all arms)4
Subliminal Perception Check
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.
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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