Simple Cognitive Task After Trauma

August 31, 2022 updated by: Emily Holmes, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of intrusive memories of traumatic event
Time Frame: Week 1
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of intrusive memories of traumatic event
Time Frame: 1 month
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
Time Frame: One week and 1, 3, and 6month follow-up
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
Time Frame: One week 1, 3, and 6 month follow-up
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)
Time Frame: 1 month follow-up
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
Time Frame: [One week and 1, 3, and 6 month follow-up]
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feedback Questionnaire about Participation
Time Frame: One week and 1, 3, and 6 month follow-up
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
Time Frame: Day 1, week 1, and 1, 3 and 6 month follow ups, through to study completion
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
Time Frame: Day 1
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
Time Frame: baseline, one week and 1, 3, and 6 month follow-up
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
Time Frame: baseline, one week and 1, 3, and 6 month follow-up
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
Time Frame: One week 1, 3, and 6 month follow-up
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
Time Frame: One week and 1 month follow-up
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)
Time Frame: 1, 3, and 6 month follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erik Andersson, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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