Intrusive Memories of Traumatic Event(s), Post-traumatic Stress Disorder (PTSD)
Conditions
Brief summary
Intrusive memories of traumatic events are a core feature of Post-Traumatic Stress Disorder (PTSD) and can cause substantial distress and functional impairment. Existing trauma-focused treatments are effective but often require deliberate recollection of traumatic experiences, which can be distressing for some individuals. Previous experimental studies in healthy participants found that masked reactivation of trauma-related cues, followed after a brief interval by a visuospatial interference task using Tetris gameplay, reduced the frequency and emotional intensity of intrusive memories. Building on these findings, the present randomized controlled trial evaluates the efficacy of this intervention in trauma-exposed individuals experiencing three or more intrusive memories per week.
Detailed description
This randomized controlled trial aims to evaluate an intervention for reducing intrusive memories in trauma-exposed individuals. Participants will be randomly assigned to either an intervention group or a control group. Before the intervention, participants assigned to the intervention group will provide images related to their traumatic experiences for use in the subsequent memory-reactivation procedure. The intervention group will undergo trauma-related memory reactivation, a music interval, and a visuospatial interference task, whereas the control group will complete only the visuospatial task. Intrusive memories and related symptoms will be assessed during follow-up.
Interventions
BEHAVIORALSubliminal Reactivation Followed by Visuospatial Interference
In each intervention session, participants are exposed subliminally to trauma-related cues. Participants then complete a 10-minute music-listening task during the post-reactivation interval, followed by a computerized visuospatial interference task (Tetris) with mental rotation instructions.
BEHAVIORALComputer-based Visuospatial Task (Tetris)
A computerized visuospatial task (Tetris) with mental rotation instructions.
Sponsors
Shaanxi Normal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Meet DSM-5 PTSD Criterion A (eg, exposure to actual or threatened death). Have experienced one or more traumatic events. 2. Experienced three or more intrusive memories during the baseline week. 3. Have internet access and have access to a personal computer. 4. Be willing to provide consent and able to complete study procedures and be contacted by the study team.
Exclusion criteria
1. Have fewer than three intrusive memories during the baseline week. 2. A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior. 3. Have severe substance dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of trauma-related intrusive memories | Day 30 - 36(all arms) controlling for baseline week | Number of trauma-related intrusive memories assessed via a daily diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of trauma-related intrusive memories | Day 12 - 18 (all arms) controlling for baseline week | Number of trauma-related intrusive memories assessed via a daily diary. |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline (day 0) and day 37 (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. |
| Intrusive memory ratings | Baseline(day 0), Day 18, day 36, 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, 2, 10, 11, 19, 20, 28, 29 (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), day19, day37, 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. |
| Impact of Event Scale-Revised (IES-R) | Baseline(day 0), day19, day37, 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), day19, day37, 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), day19, day37, 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), day19, day37, 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). |
Countries
China
Contacts
CONTACTZhu Zijian
Outcome results
None listed