Post-traumatic Stress Disorder (PTSD)NCT07767396
Eye Movement Intervention With Different Memory Reactivation Procedures for Intrusive Traumatic Memories
A study testing Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements and Neutral Memory Reactivation plus Eye Movements in people with Post-traumatic Stress Disorder (PTSD) and Intrusive Memories of Traumatic Event(s), run by Shaanxi Normal University at 1 site in China.
Trial summary
Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Intrusive Memories of Traumatic Event(s)
- What is being tested?
- Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements and Neutral Memory Reactivation plus Eye Movements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
School of Psychology, Shaanxi Normal University
Xi'an, Shaanxi, 710062
About this study
Official 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
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.
Read the detailed description
- 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.
- Being tested
- Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements, Neutral Memory Reactivation plus Eye Movements
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconscious Trauma Reactivation plus Eye MovementsBehavioural
Participants will complete a procedure involving unconscious activation combined with eye movements.
Active Trauma Memory Reactivation plus Eye MovementsBehavioural
Participants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements.
Neutral Memory Reactivation plus Eye MovementsBehavioural
Participants will complete a standardized procedure involving recall of a neutral memory combined with eye movements.
| Study group | Role | What they receive |
|---|---|---|
| Unconscious Trauma-Related Visual Processing plus Eye Movements | Experimental | Participants in this arm will complete a standardized procedure of trauma-related visual cues together with eye movements. The procedure is intended to minimize conscious awareness of the trauma-related cues. Receives: Behavioral: Unconscious Trauma Reactivation plus Eye Movements |
| Active Trauma Recall plus Eye Movements | Active comparator | Participants in this arm will complete a standardized EMDR-informed procedure involving active recall of a trauma-related memory together with eye movements. Receives: Behavioral: Active Trauma Memory Reactivation plus Eye Movements |
| Neutral Memory Reactivation plus Eye Movements | Sham comparator | Participants in this arm will complete a standardized neutral memory recall procedure together with eye movements. The neutral material will be unrelated to the participant's traumatic experience or intrusive memories. Receives: Behavioral: Neutral Memory Reactivation plus Eye Movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of trauma-related intrusive memories
Total number of trauma-related intrusive memories recorded in a daily diary over the 7-day assessment period.
Measured: Day 66 - 72(all arms) controlling for baseline week
Secondary outcomes (9)
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a daily diary.
Measured: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week
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).
Measured: Baseline(day 0), day 24, day 48, day 72, 2 months after the last intervention(all arms)
Post-Intervention Questionnaire
A 3-item questionnaire assessed participants' immediate subjective experience after each intervention session: distress and aversion experienced during the procedure (0=not at all to 10=very); acceptability of the intervention task (0=not at all to 10=very).
Measured: 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.
Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Measured: Baseline (day 0) and day 73 (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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Zijian, Shaanxi Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767396
- Sponsor's protocol ID
- XAJWKY-2026014
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07767396
- Acronym / sponsor ID
- XAJWKY-2026014
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Shaanxi Normal UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unconscious Trauma-Related Visual Processing plus Eye Movements | Experimental | Behavioral: Unconscious Trauma Reactivation plus Eye MovementsParticipants in this arm will complete a standardized procedure of trauma-related visual cues together with eye movements. The procedure is intended to minimize conscious awareness of the trauma-related cues. |
| Active Trauma Recall plus Eye Movements | Active comparator | Behavioral: Active Trauma Memory Reactivation plus Eye MovementsParticipants in this arm will complete a standardized EMDR-informed procedure involving active recall of a trauma-related memory together with eye movements. |
| Neutral Memory Reactivation plus Eye Movements | Sham comparator | Behavioral: Neutral Memory Reactivation plus Eye MovementsParticipants in this arm will complete a standardized neutral memory recall procedure together with eye movements. The neutral material will be unrelated to the participant's traumatic experience or intrusive memories. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unconscious Trauma Reactivation plus Eye MovementsParticipants will complete a procedure involving unconscious activation combined with eye movements. | Behavioural | Unconscious Trauma-Related Visual Processing plus Eye Movements |
| Active Trauma Memory Reactivation plus Eye MovementsParticipants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements. | Behavioural | Active Trauma Recall plus Eye Movements |
| Neutral Memory Reactivation plus Eye MovementsParticipants will complete a standardized procedure involving recall of a neutral memory combined with eye movements. | Behavioural | Neutral Memory Reactivation plus Eye Movements |
Primary outcome
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.
9 secondary outcomes
Number of trauma-related intrusive memories
Time frame: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week
Intrusive memory ratings
Time frame: Baseline(day 0), day 24, day 48, day 72, 2 months after the last intervention(all arms)
Post-Intervention Questionnaire
Time frame: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline (day 0) and day 73 (all arms)
Impact of Event Scale-Revised (IES-R)
Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
State-Trait Anxiety Inventory-State version (STAI-S)
Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements and Neutral Memory Reactivation plus Eye Movements in people with Post-traumatic Stress Disorder (PTSD) and Intrusive Memories of Traumatic Event(s), run by Shaanxi Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu Zijian (+86 13572494696, zhuzijian0203@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of trauma-related intrusive memories (time frame: Day 66 - 72(all arms) controlling for baseline week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.