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Posttraumatic Stress DisorderNCT06129435

Effects of Games on Memory Reconsolidation and Trauma Symptoms

A study testing Visuospatial Task (VST) and Word Association Task (WAT) in people with Posttraumatic Stress Disorder and Trauma, run by University of Texas at Austin at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Posttraumatic Stress Disorder, Trauma
What is being tested?
Visuospatial Task (VST) and Word Association Task (WAT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
23 Feb 2024to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Michael J Telch, PhD contact

(512) 560-4100

telch@austin.utexas.edu

Estrella V Thomas, MA contact

‪(512) 766-9395‬

utgamestudy@utexas.edu

United States1 site, 1 recruiting
  • The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin

    Austin, Texas, 78712

    Michael J Telch, PhD, 512-560-4100, telch@austin.utexas.edu

    Estrella V Thomas, MA, (512) 766-9395‬, utgamestudy@utexas.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Visuospatial Task (VST), Word Association Task (WAT)
Keywords
PTSD, Trauma, Behavioral task, Memory reconsolidation, Memory disruptor
Medical subject headings
Stress Disorders, Post-Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visuospatial Task (VST)Behavioural

    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.

  • Word Association Task (WAT)Behavioural

    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.

Study groups in NCT06129435
Study groupRoleWhat they receive
Visuospatial Task (VST)ExperimentalNot described
Receives: Behavioral: Visuospatial Task (VST)
Word Association Task (WAT)Sham comparatorNot described
Receives: Behavioral: Word Association Task (WAT)
No Game Play (NT-CTRL)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Momentary Assessment of Distress Scale

    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.

    Measured: Change from Baseline to Two-week Follow-up

Secondary outcomes (7)
  1. Subjective Units of Distress Scale - Peak

    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.

    Measured: Change from Baseline to Two-week Follow-up

  2. Posttraumatic Stress Disorder Checklist

    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").

    Measured: Change from Baseline to Two-week Follow-up

  3. Posttraumatic Cognition Inventory

    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.

    Measured: Change from Baseline to Two-week Follow-up

  4. Posttraumatic Safety Behaviors Inventory

    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.

    Measured: Change from Baseline to Two-week Follow-up

  5. Posttraumatic Growth Inventory

    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).

    Measured: Change from Baseline to Two-week Follow-up

  6. Trauma Coping Self-Efficacy Scale

    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").

    Measured: Change from Baseline to Two-week Follow-up

  7. Connor-Davidson Resilience Scale

    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.

    Measured: Change from Baseline to Two-week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start23 Feb 2024
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129435
Sponsor's protocol ID
STUDY00005088
Status last verified
Mar 2024
First submitted
3 Nov 2023
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bolsoni LM, Crippa JAS, Hallak JEC, Guimaraes FS, Zuardi AW. Effects of cannabidiol on symptoms induced by the recall of traumatic events in patients with posttraumatic stress disorder. Psychopharmacology (Berl). 2022 May;239(5):1499-1507. doi: 10.1007/s00213-021-06043-y. Epub 2022 Jan 14.

    PubMed 35029706
  • Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.

    PubMed 15677582
  • Deforges C, Fort D, Stuijfzand S, Holmes EA, Horsch A. Reducing childbirth-related intrusive memories and PTSD symptoms via a single-session behavioural intervention including a visuospatial task: A proof-of-principle study. J Affect Disord. 2022 Apr 15;303:64-73. doi: 10.1016/j.jad.2022.01.108. Epub 2022 Jan 30.

    PubMed 35108604
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343
  • Hagenaars MA, Holmes EA, Klaassen F, Elzinga B. Tetris and Word games lead to fewer intrusive memories when applied several days after analogue trauma. Eur J Psychotraumatol. 2017 Oct 31;8(sup1):1386959. doi: 10.1080/20008198.2017.1386959. eCollection 2017.

    PubMed 29152159
  • Hembree EA, Foa EB, Dorfan NM, Street GP, Kowalski J, Tu X. Do patients drop out prematurely from exposure therapy for PTSD? J Trauma Stress. 2003 Dec;16(6):555-62. doi: 10.1023/B:JOTS.0000004078.93012.7d.

    PubMed 14690352
  • James EL, Bonsall MB, Hoppitt L, Tunbridge EM, Geddes JR, Milton AL, Holmes EA. Computer Game Play Reduces Intrusive Memories of Experimental Trauma via Reconsolidation-Update Mechanisms. Psychol Sci. 2015 Aug;26(8):1201-15. doi: 10.1177/0956797615583071. Epub 2015 Jul 1.

    PubMed 26133572
  • Kessler H, Holmes EA, Blackwell SE, Schmidt AC, Schweer JM, Bucker A, Herpertz S, Axmacher N, Kehyayan A. Reducing intrusive memories of trauma using a visuospatial interference intervention with inpatients with posttraumatic stress disorder (PTSD). J Consult Clin Psychol. 2018 Dec;86(12):1076-1090. doi: 10.1037/ccp0000340.

    PubMed 30507232
  • Kessler H, Schmidt AC, James EL, Blackwell SE, von Rauchhaupt M, Harren K, Kehyayan A, Clark IA, Sauvage M, Herpertz S, Axmacher N, Holmes EA. Visuospatial computer game play after memory reminder delivered three days after a traumatic film reduces the number of intrusive memories of the experimental trauma. J Behav Ther Exp Psychiatry. 2020 Jun;67:101454. doi: 10.1016/j.jbtep.2019.01.006. Epub 2019 Jan 25.

    PubMed 31036259
  • Kessler RC, Aguilar-Gaxiola S, Alonso J, Benjet C, Bromet EJ, Cardoso G, Degenhardt L, de Girolamo G, Dinolova RV, Ferry F, Florescu S, Gureje O, Haro JM, Huang Y, Karam EG, Kawakami N, Lee S, Lepine JP, Levinson D, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Scott KM, Stein DJ, Ten Have M, Torres Y, Viana MC, Petukhova MV, Sampson NA, Zaslavsky AM, Koenen KC. Trauma and PTSD in the WHO World Mental Health Surveys. Eur J Psychotraumatol. 2017 Oct 27;8(sup5):1353383. doi: 10.1080/20008198.2017.1353383. eCollection 2017.

    PubMed 29075426
  • Nader K, Schafe GE, Le Doux JE. Fear memories require protein synthesis in the amygdala for reconsolidation after retrieval. Nature. 2000 Aug 17;406(6797):722-6. doi: 10.1038/35021052.

    PubMed 10963596
  • Schottenbauer MA, Glass CR, Arnkoff DB, Tendick V, Gray SH. Nonresponse and dropout rates in outcome studies on PTSD: review and methodological considerations. Psychiatry. 2008 Summer;71(2):134-68. doi: 10.1521/psyc.2008.71.2.134.

    PubMed 18573035

Questions about this trial

What is this clinical trial studying?

A study testing Visuospatial Task (VST) and Word Association Task (WAT) in people with Posttraumatic Stress Disorder and Trauma, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael J Telch, PhD ((512) 560-4100, telch@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Momentary Assessment of Distress Scale (time frame: Change from Baseline to Two-week Follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129435, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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