NCT06129435

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

November 3, 2023

Last Update Submit

March 1, 2024

Conditions

Posttraumatic Stress DisorderTrauma

Keywords

PTSDTraumaBehavioral taskMemory reconsolidationMemory disruptor

Outcome Measures

Primary Outcomes (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.

    Change from Baseline to Two-week Follow-up

Secondary Outcomes (7)

  • Subjective Units of Distress Scale - Peak

    Change from Baseline to Two-week Follow-up

  • Posttraumatic Stress Disorder Checklist

    Change from Baseline to Two-week Follow-up

  • Posttraumatic Cognition Inventory

    Change from Baseline to Two-week Follow-up

  • Posttraumatic Safety Behaviors Inventory

    Change from Baseline to Two-week Follow-up

  • Posttraumatic Growth Inventory

    Change from Baseline to Two-week Follow-up

  • +2 more secondary outcomes

Study Arms (3)

Visuospatial Task (VST)

EXPERIMENTAL
Behavioral: Visuospatial Task (VST)

Word Association Task (WAT)

SHAM COMPARATOR
Behavioral: Word Association Task (WAT)

No Game Play (NT-CTRL)

NO INTERVENTION

Interventions

Visuospatial Task (VST)BEHAVIORAL

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.

Visuospatial Task (VST)
Word Association Task (WAT)BEHAVIORAL

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.

Word Association Task (WAT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Related Publications (12)

  • 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.

    PMID: 35029706BACKGROUND

  • 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.

    PMID: 15677582BACKGROUND

  • 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.

    PMID: 35108604BACKGROUND

  • 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.

    PMID: 17695343BACKGROUND

  • 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.

    PMID: 29152159BACKGROUND

  • 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.

    PMID: 14690352BACKGROUND

  • 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.

    PMID: 26133572BACKGROUND

  • 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.

    PMID: 30507232BACKGROUND

  • 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.

    PMID: 31036259BACKGROUND

  • 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.

    PMID: 29075426BACKGROUND

  • 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.

    PMID: 10963596BACKGROUND

  • 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.

    PMID: 18573035BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Michael J Telch, PhD

CONTACT

(512) 560-4100telch@austin.utexas.edu

Estrella V Thomas, MA

CONTACT

‪(512) 766-9395‬utgamestudy@utexas.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 13, 2023

Study Start

February 23, 2024

Primary Completion

October 31, 2024

Study Completion

August 31, 2025

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)