Intrusive Memories of Traumatic Event(s), Post-traumatic Stress Disorder (PTSD)
Conditions
Brief 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. 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
1. This study will be conducted on an online platform, which will be used for data collection, task management, and recording of experimental results. 2. 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.
Interventions
BEHAVIORALUnconscious Trauma Reactivation plus Eye Movements
Participants will complete a procedure involving unconscious activation combined with eye movements.
BEHAVIORALActive Trauma Memory Reactivation plus Eye Movements
Participants will complete a standardized procedure involving recall of a trauma-related memory combined with eye movements.
BEHAVIORALNeutral Memory Reactivation plus Eye Movements
Participants will complete a standardized procedure involving recall of a neutral memory combined with eye movements.
Sponsors
Shaanxi Normal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Experienced five or more trauma-related intrusive memories during the baseline week. 3. Have internet access and access to a personal computer suitable for completing the online study tasks. 4. Have normal or corrected-to-normal vision and be able to complete computerized visual and eye movement tasks. 5. Be willing to provide informed consent, able to complete study procedures, and able to be contacted by the study team.
Exclusion criteria
1. Have fewer than five trauma-related intrusive memories during the baseline week. 2. 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. 3. Have current acute suicidal ideation or behavior, significant risk of harm to self or others, or any condition requiring urgent clinical intervention. 4. Have current severe substance use disorder or severe substance dependence judged to interfere with study participation or safety. 5. 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. 6. Have visual impairment or other condition that prevents completion of the computerized visual or eye movement tasks. 7. Current participation in another intervention study or current treatment judged by the research team to interfere with study participation, safety, or outcome assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of trauma-related intrusive memories | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of trauma-related intrusive memories | Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week | Number of trauma-related intrusive memories assessed via a daily diary. |
| Intrusive memory ratings | 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). |
| Post-Intervention Questionnaire | 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). |
| PTSD Checklist for DSM-5 (PCL-5) | 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. |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 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. |
| Impact of Event Scale-Revised (IES-R) | 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. |
| Beck Depression Inventory-II (BDI-II) | 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. |
| State-Trait Anxiety Inventory-State version (STAI-S) | 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. |
| Work and Social Adjustment Scale (WSAS) | 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). |
Contacts
CONTACTZhu Zijian
Outcome results
None listed