Tetris-intervention efter subliminal reaktivering for påtrængende minder
30. august 2026 opdateret af: Zhu Zijian, Shaanxi Normal University
En Tetris-intervention efter subliminal reaktivering for at reducere påtrængende minder hos traumeeksponerede individer: et randomiseret kontrolleret forsøg
Posttraumatisk stressforstyrrelse (PTSD) er kendetegnet ved tilbagevendende, påtrængende minder om traumatiske begivenheder, der forårsager betydelig distress og funktionel nedsættelse. Selvom traumefokuseret behandling er effektiv, kræver den typisk bevidst erindring af traumatiske oplevelser, hvilket kan være forstyrrende og kan bidrage til behandlingsundgåelse eller frafald.
I tidligere eksperimentelle studier udført med raske deltagere demonstrerede vi, at ubevidst reaktivering af traumarelaterede signaler, efterfulgt af en kort forsinkelse svarende til hukommelsesrekonsolideringsvinduet – af en visuospatial interferensopgave (Tetris-spil), reducerede hyppigheden og den følelsesmæssige intensitet af påtrængende minder. Disse resultater tyder på, at hukommelsesrepræsentationer kan ændres under rekonsolidering uden at kræve bevidst erindring.
Baseret på dette arbejde har den nuværende randomiserede kontrollerede undersøgelse (RCT) til formål at evaluere den kliniske effektivitet og tolerabilitet af denne rekonsolideringsbaserede intervention hos traumeeksponerede personer, der oplever fem eller flere påtrængende minder om ugen.
Studieoversigt
Status
Rekruttering
Detaljeret beskrivelse
Denne undersøgelse vil blive udført på en online platform, som vil blive brugt til dataindsamling, opgavehåndtering og registrering af eksperimentelle resultater.
Før registreringen af basislinje-dagbogen skal hver deltager indsende fire billeder relateret til deres traumeerfaring til brug i efterfølgende eksperimenter. Indsendelsen af disse billeder er frivillig, og deltagerne er fuldt informeret om den tilsigtede brug af deres billeder.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
106
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhu Zijian
- Telefonnummer: +86 13572494696
- E-mail: zhuzijian0203@snnu.edu.cn
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710062
- Rekruttering
- School of Psychology, Shaanxi Normal University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Opfylde DSM-5 PTSD Kriterium A (f.eks. udsat for faktisk eller truet død). Have oplevet en eller flere traumatiske begivenheder.
- Oplevet fem eller flere indtrængende minder i grundlinjeugen.
- Have internetadgang og have adgang til en personlig computer.
- Være villig til at give samtykke og være i stand til at gennemføre studiprocedurer og blive kontaktet af studieteamet.
Eksklusionskriterier:
- Have færre end fem indtrængende minder i grundlinjeugen.
- En nuværende diagnose af skizofreni, obsessive-compulsiv lidelse (OCD), en alvorlig personlighedsforstyrrelse vurderet til at forstyrre behandlingsoverholdelse, eller akut suicidal adfærd.
- Have alvorlig stofafhængighed.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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-komparator: 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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En computeriseret visuospatial opgave (Tetris) med mentale rotationsinstruktioner.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of trauma-related intrusive memories
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of trauma-related intrusive memories
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antal traumarelaterede påtrængende erindringer
Tidsramme: 2 måneder efter den sidste intervention (alle arme)
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Antallet af traumarelaterede indtrængende minder vurderet via et enkelt spørgsmål.
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2 måneder efter den sidste intervention (alle arme)
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Changes to health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. april 2026
Primær færdiggørelse (Anslået)
10. juni 2028
Studieafslutning (Anslået)
30. juli 2028
Datoer for studieregistrering
Først indsendt
21. marts 2026
Først indsendt, der opfyldte QC-kriterier
21. marts 2026
Først opslået (Faktiske)
27. marts 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XAJWKY-2025062
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- ANALYTIC_CODE
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