Clinical trial NCT06129435: Effects of Games on Memory Reconsolidation and Trauma Symptoms
Official title: Effects of Behavioral Tasks on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Trauma
Keywords: PTSD
Trauma
Behavioral task
Memory reconsolidation
Memory disruptor
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a visuospatial task on memory reconsolidation and trauma symptoms for trauma-exposed individuals after exposure to traumatic memory reactivation paradigm.

Detailed description: It is estimated that over 70% of individuals worldwide have experienced a trauma within their lifetime. Many people spontaneously recover without formal intervention or treatment after exposure to a traumatic event, however, some individuals may develop intrusive trauma-related memories, avoidance, negative changes in cognitions or mood, or changes in arousal and reactivity, resulting in clinical or sub-clinical symptoms of posttraumatic stress disorder (PTSD). Although empirically supported trauma-focused treatments currently exist (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy), they are typically economically expensive, time consuming, require therapy sessions with a specialized provider, and have moderate to high nonresponse and dropout rates (20-50%). As such, there is a need for novel and palatable prevention and treatment strategies for PTSD.

Innovative preclinical research has revealed that, after memory retrieval, previously consolidated memories temporarily enter a labile state and become vulnerable to pharmacological and behavioral disruptors. The impermanence of memory has potential clinical applications for the secondary prevention and treatment of memory-based psychiatric disorders (e.g., anxiety disorder and PTSD). Several randomized controlled experiments with healthy volunteers have shown that engaging in a taxing visuospatial task (playing the game Tetris) 24 hours, or up to four days, after viewing traumatic film (analogue trauma) significantly reduced the subsequent number of intrusive memories relative to those who completed no task or who played a control game. Similar findings have been replicated among individuals with PTSD. One study found that participants with complex and longstanding PTSD demonstrated a decrease in intrusive trauma memories after undergoing a trauma memory reminder and playing Tetris for 25 minutes in an inpatient treatment setting. Similarly, participants with a history of traumatic birth who underwent a trauma memory reminder and a single session of Tetris gameplay displayed significant reduction of intrusive memory frequency at one-month follow-up. Taken together, these findings suggest that visuospatial disruptors (i.e., playing Tetris) may have clinical utility in preventing or treating PTSD.

The overarching objective of this study is to investigate the effects of a visuospatial task on memory reconsolidation and trauma symptoms among trauma-exposed individuals after exposure to a trauma memory reactivation paradigm. To accomplish this, the investigators will conduct a three-arm placebo-controlled randomized clinical trial. The three treatment conditions of the proposed study are: (1) visuospatial task (VST); (2) word association task (WAT); or (3) no treatment control condition (NT-CTRL).

The current study intends to expound upon this emerging area of research by conducting a randomized controlled trial investigating the effects of behavioral disruptors (i.e., playing Tetris, playing a word association game, or no-game play control) after a trauma memory reactivation procedure among a trauma-exposed population.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65
* Fluent in written and spoken English
* Has access to the internet
* Access to a computer (laptop or desktop) with a camera that has video and audio recording capability
* History of trauma exposure to either a motor vehicle (MVC), sexual assault, physical assault, or combat.

Exclusion Criteria:

* Insufficient emotional reactivity to the trauma memory reactivation video clip (\<5 the Peak Subjective Units of Distress Scale)
* Presence of significant suicidality or a history of a suicide attempt within the past 6 months
* History of psychosis within the past 6 months
* Changes in psychotropic medication (≤ 8 weeks)
* Currently receiving trauma-focused psychotherapy

Primary outcomes:
measure: Momentary Assessment of Distress Scale
timeFrame: Change from Baseline to Two-week Follow-up
Secondary outcomes:
measure: Subjective Units of Distress Scale - Peak
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Stress Disorder Checklist
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Cognition Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Safety Behaviors Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Growth Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Trauma Coping Self-Efficacy Scale
timeFrame: Change from Baseline to Two-week Follow-up
measure: Connor-Davidson Resilience Scale
timeFrame: Change from Baseline to Two-week Follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin
state: Texas
Study officials:
References:
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