Tetris Intervention Following Subliminal Reactivation for Intrusive Memories
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShaanxi Normal University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Subliminal Reactivation
BehavioralIn each intervention session, participants are exposed subliminally to trauma-related cues and then complete a computerized visuospatial task (Tetris) with mental rotation instructions.
Computer-based Visuospatial Task (Tetris)
BehavioralA computerized visuospatial task (Tetris) with mental rotation instructions.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Unconscious ReactivationExperimental treatment 1 intervention
Group B: No Reactivation ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a daily diary.
Time frame
Day 66 - 72(all arms) controlling for baseline weekSecondary outcomes
1
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a daily diary.
Time frame
Day 18 - 24 , Day 42 - 48(all arms) controlling for baseline week2
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Time frame
Baseline (day 0) and day 73 (all arms)3
Intrusive memory ratings
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).
Time frame
Day 24, day 48, day 72, 2 months after the last intervention(all arms)4
Post-Intervention Questionnaire
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).
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)Other outcomes
1
Changes to health
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.
Time frame
Day73 and 2 months after the last intervention(all arms)2
Feedback questionnaire
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.
Time frame
Day65 (all arms)3
Number of trauma-related intrusive memories
Number of trauma-related intrusive memories assessed via a single item .
Time frame
2 months after the last intervention (all arms)4
Subliminal Perception Check
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.
Time frame
Day1, 9, 17, 25, 33, 41, 49, 57, 65 (the Unconscious Reactivation group only)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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