Simple Cognitive Task After Trauma

Preventing Intrusive Memories After Trauma Via a Simple Cognitive Intervention in the Hospital Emergency Department: "EKUT" (Enkel Kognitiv Uppgift Efter Trauma)

This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game "Tetris") on intrusive memories ("flashbacks") and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event will be randomly allocated to either the simple cognitive task intervention or control. Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation aspects in a new hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorders
• Intervention / Treatment: Behavioral: Simple cognitive task; Behavioral: Attention placebo

Detailed Description

This is an explorative pilot study, which will guide the design of a future Randomised Controlled Trial. The main aim of the present study is not a statistical significance test, the results will be descriptive, and will include pilot analyses to obtain an estimate of effect size between groups of the current primary outcome measure.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 171 76
      • Akuten Huddinge Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 or over
• Experienced or witnessed a traumatic event resulting in admission to the emergency department for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
• Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) ("The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by "Direct exposure" or "Witnessing the trauma") )
• Can be seen in the emergency department within 6 hours after the traumatic event
• Report memory of the accident
• Fluent in Swedish
• Alert and orientated
• Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands).
• Willing and able to provide informed consent and complete study procedures
• Willing and able to be contacted following discharge to complete follow-up assessments
• Have access to an internet enabled smartphone
• in addition to point above "can be seen in the emergency department within 6 hours after the traumatic event", from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event

Exclusion Criteria:

• Loss of consciousness of > 5 minutes
• Current intoxication
• Report a history of severe mental illness
• Current substance abuse or neurological condition
• Currently suicidal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simple cognitive task; A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1.	Behavioral: Simple cognitive task; A memory cue followed by playing the computer game "Tetris" on own smartphone. Options to engage in self-administered booster sessions after day 1.
Placebo Comparator: Attention placebo; Smartphone activity for same amount of time.	Behavioral: Attention placebo; Smartphone activity for same amount of time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories of traumatic event	Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for 7 days	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories of traumatic event	Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for 7 days	1 month
Impact of Event Scale - Revised (IES-R) Intrusion Subscale: Degree of subjective distress of post-trauma symptoms in the intrusion (re-experiencing) symptoms cluster	Full scale is a 22-item self-report measure that assesses subjective distress after a traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores are calculated for the Intrusion, Avoidance, and Hyperarousal subscales summed. Higher scores indicate worse outcome. Our secondary outcome measure is the Intrusion subscale.	One week and 1, 3, and 6month follow-up
Hospital Anxiety and Depression Scale (HADS): Anxiety and depressive symptoms	The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate worse severity.	One week 1, 3, and 6 month follow-up
Perceived Stress Scale (PSS)	Measures the perception of stress and the degree to which situations in one's life are appraised as stressful. The 14 items aims to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are rated on a 5-point scale ranging from 0 ("never") to 4 ("very often") and summed to a total score of 56. Seven items concerns positive experiences and are hence reversed in scoring. Higher scores indicate worse severity.	1 month follow-up
Work and Social Adjustment Scale (WSAS): Daily function	The Work & Social Adjustment Scale is a simple 5-item measure of general social impairment which grew out of a study of change during psychotherapy. The maximum score of the WSAS is 40, lower scores are better.	[One week and 1, 3, and 6 month follow-up]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback Questionnaire about Participation	22 bespoke items including questions about study participation e.g. how burdensome was it to participate in the study?" rated on 9-point scale from 1 (never) to 9 (always); and those about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since our last contact; and items with a free text response field e.g. do you have any comments about what it was like to take part in the study.	One week and 1, 3, and 6 month follow-up
Implementation feedback	Observation and qualitative interviews with participants, study team and staff regarding implementation of the procedures	Day 1, week 1, and 1, 3 and 6 month follow ups, through to study completion
Credibility/expectancy questionnaire: Treatment credibility	5 item questionnaire (11 item scale from 0 to 10) that rates to what degree the participants finds the intervention credible. High scores indicate greater credibility. A free text response field about activities engaged in during the assigned condition.	Day 1
Self Rated Health (SRH) rating	A single item measuring perceived health status on a seven-point scale (from very good to very bad). High scores indicate good outcomes.	baseline, one week and 1, 3, and 6 month follow-up
Self rated Sleep ratings	Two self rated items: Item 1 measures the extent of being troubled by poor sleep in the last month on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (0 - 4) then summed. Possible total scores ranges from 0 - 8, with higher values indicative of better sleep.	baseline, one week and 1, 3, and 6 month follow-up
Adverse events	Adverse events and potential side effects associated with intervention	One week 1, 3, and 6 month follow-up
Characteristics and sensory modality of intrusive trauma memories	7 self rated bespoke items measuring characteristics and sensory modality of intrusive memories: 1 self rated question regarding the presence and the extent of each of 7 sensory modalities in the intrusive memories (visual, auditory, tactile, somatic, olfactory, taste, and other sensations) measured on a scale from 1 (none) to 5 (extreme). 3 self rated items measuring the level of distress, vividness or disruption (functional impairment) associated with the intrusions (11 point scales from 0 to 10). High scores indicate higher level of distress/vividness/disruption.	One week and 1 month follow-up
M.I.N.I 7.0.0 (Mini International Neuropsychiatric Interview version 7.0.0) - Section H. Posttraumatic stress disorder (PTSD)	Section H of MINI 7.0.0 (a short symptom interview) will be assessed at follow-ups to assess current symptoms of posttraumatic stress disorder. Section H consists of a minimum of 1 and maximum of 19 items, which continue depending on response to previous question). Higher scores indicate worse symptoms	1, 3, and 6 month follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik Andersson, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Kanstrup M, Singh L, Goransson KE, Widoff J, Taylor RS, Gamble B, Iyadurai L, Moulds ML, Holmes EA. Reducing intrusive memories after trauma via a brief cognitive task intervention in the hospital emergency department: an exploratory pilot randomised controlled trial. Transl Psychiatry. 2021 Jan 11;11(1):30. doi: 10.1038/s41398-020-01124-6.
• Kanstrup M, Rudman A, Goransson K, Andersson E, Lauri KO, Rapoport E, Sunnergard L, Bragesjo M, Andersson E, Iyadurai L, Holmes EA. Reaching people soon after a traumatic event: an exploratory observational feasibility study of recruitment in the emergency department to deliver a brief behavioral intervention via smartphone to prevent intrusive memories of trauma. Pilot Feasibility Stud. 2021 Oct 7;7(1):184. doi: 10.1186/s40814-021-00916-x.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): July 12, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2017/2215-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No