- 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
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhu Zijian
- Phone Number: +86 13572494696
- Email: zhuzijian0203@snnu.edu.cn
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710062
- Recruiting
- School of Psychology, Shaanxi Normal University
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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 three 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 three 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-related cues are presented below the threshold of conscious awareness.
Following reactivation, participants complete a 10-minute music-listening task, after which they perform a computerized visuospatial interference task (Tetris) with mental rotation instructions.
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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.
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Sham Comparator: No Reactivation Control
Participants in this control arm will not undergo trauma memory reactivation.
They will proceed directly to a computerized visuospatial task (Tetris) with mental rotation instructions.
This condition serves as a comparator for evaluating the effects of the experimental intervention while controlling for the nonspecific effects associated with engagement in the visuospatial task.
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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 |
|---|---|---|
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Number of trauma-related intrusive memories
Time Frame: Day 30 - 36(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 30 - 36(all arms) controlling for baseline week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of trauma-related intrusive memories
Time Frame: Day 12 - 18 (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 12 - 18 (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 37 (all arms)
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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.
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Baseline (day 0) and day 37 (all arms)
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Intrusive memory ratings
Time Frame: Baseline(day 0), Day 18, day 36, 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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Baseline(day 0), Day 18, day 36, 2 months after the last intervention(all arms)
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Post-Intervention Questionnaire
Time Frame: Day1, 2, 10, 11, 19, 20, 28, 29 (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, 2, 10, 11, 19, 20, 28, 29 (all arms)
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PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline(day 0), day19, day37, 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), day19, day37, 2 months after the last intervention(all arms)
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Impact of Event Scale-Revised (IES-R)
Time Frame: Baseline(day 0), day19, day37, 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), day19, day37, 2 months after the last intervention(all arms)
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Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline(day 0), day19, day37, 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), day19, day37, 2 months after the last intervention(all arms)
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State-Trait Anxiety Inventory-State version (STAI-S)
Time Frame: Baseline(day 0), day19, day37, 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), day19, day37, 2 months after the last intervention(all arms)
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Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline(day 0), day19, day37, 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), day19, day37, 2 months after the last intervention(all arms)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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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Changes to health
Time Frame: Day37 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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Day37 and 2 months after the last intervention(all arms)
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Feedback questionnaire
Time Frame: Day29 (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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Day29 (all arms)
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Subliminal Perception Check
Time Frame: Day1, 2, 10, 11, 19, 20, 28, 29 (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, 2, 10, 11, 19, 20, 28, 29 (the Unconscious Reactivation group only)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
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