NCT07495917

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

March 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 21, 2026

Last Update Submit

March 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of trauma-related intrusive memories

    Number of trauma-related intrusive memories assessed via a daily diary.

    Day 66 - 72(all arms) controlling for run-in/baseline week

Secondary Outcomes (8)

  • Number of trauma-related intrusive memories

    Day 18 - 24 , Day 42 - 48(all arms) controlling for run-in/baseline week

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Baseline (day 0) and day 73 (all arms)

  • Intrusive memory ratings

    Day 24, day 48, day 72, 2 months after the last intervention(all arms)

  • PTSD Checklist for DSM-5 (PCL-5)

    Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  • Impact of Event Scale-Revised (IES-R)

    Baseline(day 0), day25, day49, day73, 2 months after the last intervention(all arms)

  • +3 more secondary outcomes

Other Outcomes (4)

  • Changes to health

    Day73 and 2 months after the last intervention(all arms)

  • Feedback questionnaire

    Day65 (all arms)

  • Post-Intervention Questionnaire

    Day1, 9, 17, 25, 33, 41, 49, 57, 65 (all arms)

  • +1 more other outcomes

Study Arms (3)

Unconscious Reactivation

EXPERIMENTAL

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.

Behavioral: Subliminal Cue + Visuospatial Task

Conscious Reactivation

EXPERIMENTAL

Participants in this experimental arm will undergo active, supraliminal (conscious) reactivation of trauma-related memories. This arm serves as the standard clinical benchmark to test the established reconsolidation-interference framework, where the target memory is explicitly recalled prior to intervention.

Behavioral: Supraliminal Cue + Visuospatial Task

No Reactivation Control

SHAM COMPARATOR

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.

Behavioral: Visuospatial Task Only

Interventions

Before completing the baseline diary, participants are required to provide 4 trauma-related images. In each intervention session, participants are exposed to trauma-related cues subliminally, followed by a computer-based visuospatial task (Tetris gameplay). This task is designed to introduce targeted cognitive interference within the hypothesized reconsolidation window.

Unconscious Reactivation

Before completing the baseline diary, participants are required to provide 4 trauma-related images.Participants undergo conscious reactivation of trauma-related cues, followed by a computer-based visuospatial task (Tetris gameplay). This task is designed to introduce targeted cognitive interference within a window during which memory representations may be susceptible to modification.

Conscious Reactivation

Before completing the baseline diary, participants are required to provide 4 trauma-related images.Participants do not receive any memory reactivation cues (neither explicit nor subliminal). They directly engage in the computer-based visuospatial task (Tetris gameplay) without undergoing prior trauma memory destabilization.

No Reactivation Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2026

First Posted

March 27, 2026

Study Start

March 27, 2026

Primary Completion (Estimated)

March 27, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE