Effects of Games on Memory Reconsolidation and Trauma Symptoms

Sponsor

University of Texas at Austin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129435

Collaborator

(none)

120

Enrollment

Location

Arms

21.5

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Trauma	Behavioral: Visuospatial Task (VST) Behavioral: Word Association Task (WAT)	N/A

Detailed Description

It is estimated that over 70% of individuals worldwide have experienced a trauma within their lifetime (R. C. Kessler et al., 2017). 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) (Foa & Riggs, 1995). 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%) (Bradley et al., 2005; Hembree et al., 2003; Schottenbauer et al., 2008). 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 (e.g., Nader et al., 2000). 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 (Hagenaars et al., 2017; James et al., 2015; H. Kessler et al., 2020). 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 (H. Kessler et al., 2018). 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 (Deforges et al., 2022). 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, we 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Behavioral Tasks on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visuospatial Task (VST)	Behavioral: Visuospatial Task (VST) Participants randomized to the VST condition will play a visuospatial game (i.e., Tetris). Participants will be given two minutes to practice Tetris and then will be instructed to play for 15 minutes without stopping.
Sham Comparator: Word Association Task (WAT)	Behavioral: Word Association Task (WAT) Participants randomized to the WAT condition will play a word association game. Research staff members will read from a list of 300 words, not associated with trauma, to the participant. The participant will verbally respond to each word out loud with the first word that comes to their mind. This word association task will continue for 15 minutes or until all 300 words are read, whichever occurs first.
No Intervention: No Game Play (NT-CTRL)

Arm

Intervention/Treatment

Experimental: Visuospatial Task (VST)

Behavioral: Visuospatial Task (VST)

Participants randomized to the VST condition will play a visuospatial game (i.e., Tetris). Participants will be given two minutes to practice Tetris and then will be instructed to play for 15 minutes without stopping.

Sham Comparator: Word Association Task (WAT)

Behavioral: Word Association Task (WAT)

Participants randomized to the WAT condition will play a word association game. Research staff members will read from a list of 300 words, not associated with trauma, to the participant. The participant will verbally respond to each word out loud with the first word that comes to their mind. This word association task will continue for 15 minutes or until all 300 words are read, whichever occurs first.

No Intervention: No Game Play (NT-CTRL)

Outcome Measures

Primary Outcome Measures

Momentary Assessment of Distress Scale [Change from Baseline to Two-week Follow-up]
The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.

Secondary Outcome Measures

Subjective Units of Distress Scale - Peak [Change from Baseline to Two-week Follow-up]
The Subjective Units of Distress Scale - Peak (P-SUDS) is a measure that retrospectively assesses level of distress on a 0 (no distress) to 10 (extreme distress) scale.
Posttraumatic Stress Disorder Checklist [Change from Baseline to Two-week Follow-up]
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that assesses symptoms consistent with the DSM-5 diagnosis of PTSD. Respondents rate the frequency of each symptom over the last month utilizing a 5-point scale (0 indicating "not at all"; 4 indicating "extremely").
Posttraumatic Cognition Inventory [Change from Baseline to Two-week Follow-up]
The Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9) is a 9-item questionnaire that assesses negative posttraumatic cognition. Items are rated on a 7-point Likert scale with 1 indicating "Totally disagree" and 7 indicating "Totally agree." The instrument consists of three subscales (self-blame, negative cognitions of the self, and negative cognitions of the world) to yield the total and subscale scores, with higher scores indicating more negative posttraumatic cognitions.
Posttraumatic Safety Behaviors Inventory [Change from Baseline to Two-week Follow-up]
The Posttraumatic Safety Behavior Inventory (PSBI) is a 13-item self-report questionnaire that assesses safety behaviors related to PTSD. Items are rated on a 5-point scale with 0 indicating "Never" and 4 indicating "Always." The first 10 items of the inventory yield a summed total score. The last three items of the inventory are open-ended to record safety behavior specific to the respondent and can be used in clinical applications. Higher scores suggest more engagement with PTSD safety behaviors.
Posttraumatic Growth Inventory [Change from Baseline to Two-week Follow-up]
The Posttraumatic Growth Inventory (PGTI) is a 21-item self-report scale that measures positive outcomes associated with traumatic events. Items are rated on a 6-point scale with 0 indicating "I did not experience this as a result of my crisis" and 5 indicating "I experienced this change to a very great degree as a result of my crisis." The inventory is comprised of five factors (appreciation of life relating to others, spiritual change, new possibilities, and personal strength).
Trauma Coping Self-Efficacy Scale [Change from Baseline to Two-week Follow-up]
The Trauma Coping Self-Efficacy (CSE-T) Scale - 9-item is a brief self-report scale that assesses perceptions of coping self-efficacy following a traumatic experience. Respondents rate their perceived capacity to handle demands related to their trauma on a 7-point scale (1 indicating "Not at all capable"; 7 indicating "Totally capable").
Connor-Davidson Resilience Scale [Change from Baseline to Two-week Follow-up]
The Connor-Davidson Resilience Scale - 10 item (CD-RISC-10) is a 10-item self-report questionnaire that assesses resilience (e.g., the ability to cope with adverse experiences). Respondents rate items utilizing a 5-point scale (0 indicating "not true at all"; 4 indicating "true nearly all the time"). The summation of all items yields a total score, ranging from 0 to 40, with higher scores suggesting greater resilience.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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