- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495917
Tetris Intervention Following Subliminal Reactivation for Intrusive Memories
A Tetris Intervention Following Subliminal Reactivation for Reducing Intrusive Memories in Trauma-exposed Individuals: a Randomized Controlled Trial
Post-Traumatic Stress Disorder (PTSD) is characterized by recurrent, intrusive memories of traumatic events that cause significant distress and functional impairment. Although trauma-focused treatments are effective, they typically require deliberate recollection of traumatic experiences, which can be distressing and may contribute to treatment avoidance or dropout.
In previous experimental studies conducted with healthy participants, we demonstrated that unconscious reactivation of trauma-related cues, followed-after a brief delay corresponding to the memory reconsolidation window-by a visuospatial interference task (Tetris gameplay), reduced the frequency and emotional intensity of intrusive memories. These findings suggest that memory representations may be modifiable during reconsolidation without requiring conscious recall.
Building on this work, the present randomized controlled trial (RCT) aims to evaluate the clinical efficacy and tolerability of this reconsolidation-based intervention in trauma-exposed individuals experiencing five or more intrusive memories per week.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhu Zijian
- Phone Number: +86 13572494696
- Email: zhuzijian0203@snnu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meet DSM-5 PTSD Criterion A (eg, exposure to actual or threatened death). Have experienced one or more traumatic events.
- Experienced five or more intrusive memories during the baseline week.
- Have internet access and have access to a personal computer.
- Be willing to provide consent and able to complete study procedures and be contacted by the study team.
Exclusion Criteria:
- Have fewer than five intrusive memories during the baseline week.
- A current diagnosis of schizophrenia, obsessive-compulsive disorder (OCD), a severe personality disorder judged to interfere with treatment adherence, or acute suicidal behavior.
- Have severe substance dependence.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Unconscious Reactivation
Participants in this experimental arm will undergo subliminal (unconscious) reactivation of trauma-related memories.
Trauma cues are presented strictly below the threshold of conscious awareness to minimize psychological distress, while theoretically aiming to trigger the destabilization of the target memory.
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In each intervention session, participants are exposed subliminally to trauma-related cues and then complete a computerized visuospatial task (Tetris) with mental rotation instructions.
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Sham Comparator: No Reactivation Control
Participants in this control arm will not undergo trauma memory reactivation.
This condition is designed as a sham comparator to match the overall timing and structure of the experimental arms, isolating the specific effect of memory reactivation and controlling for the nonspecific effects of task engagement.
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A computerized visuospatial task (Tetris) with mental rotation instructions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of trauma-related intrusive memories
Time Frame: Day 66 - 72(all arms) controlling for baseline week
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Number of trauma-related intrusive memories assessed via a daily diary.
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Day 66 - 72(all arms) controlling for baseline week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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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.
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Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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Impact of Event Scale-Revised (IES-R)
Time Frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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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.
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Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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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.
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Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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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).
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Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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Number of trauma-related intrusive memories
Time Frame: Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week
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Number of trauma-related intrusive memories assessed via a daily diary.
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Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week
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Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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 combined score for each individual symptom (referred to as the "symptom score") is the sum of the frequency rating (0=Absent to 4=Extreme / incapacitating) and the intensity rating (0=Absent to 4=Extreme / incapacitating), ranging from 0 to 8. The total score of the CAPS-5 is the sum of the symptom scores for the 20 symptom items, ranging from 0 to 160 (20 items × 8 points).
A higher total score indicates greater overall severity of PTSD symptoms.
A score of 0-19 indicates no symptoms, 20-39 indicates mild, 40-59 indicates moderate, 60-79 indicates severe, and 80 or above indicates extremely severe.
Additionally, the diagnosis of CAPS-5 is not based solely on the total score; it must also meet the symptom cluster criteria of DSM-5.
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Baseline (day 0) and day 73 (all arms)
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Intrusive memory ratings
Time Frame: Day 24, day 48, day 72, 2 months after the last intervention(all arms)
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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).
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Day 24, day 48, day 72, 2 months after the last intervention(all arms)
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Post-Intervention Questionnaire
Time Frame: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)
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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).
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Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)
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State-Trait Anxiety Inventory-State version (STAI-S)
Time Frame: Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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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.
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Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes to health
Time Frame: Day73 and 2 months after the last intervention(all arms)
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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.
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Day73 and 2 months after the last intervention(all arms)
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Number of trauma-related intrusive memories
Time Frame: 2 months after the last intervention (all arms)
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Number of trauma-related intrusive memories assessed via a single item .
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2 months after the last intervention (all arms)
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Feedback questionnaire
Time Frame: Day65 (all arms)
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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.
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Day65 (all arms)
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Subliminal Perception Check
Time Frame: Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only)
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Administered only to the unconscious cue group; following each intervention, participants are asked whether they perceived any image via a single-item binary choice (Yes/No).
If the response is "Yes," an open-ended verbal description is required.
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Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XAJWKY-2025062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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