Post Traumatic Stress DisorderCALM-EDNCT04769999
Computer Assisted Lessening of Intrusive Memories in the Emergency Department
A study testing Simple cognitive task in people with Post Traumatic Stress Disorder, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
During the COVID-19 pandemic, clinical staff working in frontline NHS hospital and pre-hospital departments (e.g. emergency department, intensive care unit, ambulance service) are being faced with difficult and stressful situations, which may be traumatic to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Simple cognitive task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 4 Jun 2020to 30 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above;
- able to read, write and speak in English;
- able and willing to provide informed consent and complete study procedures;
- NHS hospital and pre-hospital clinical staff; experiencing intrusive memories, which are problematic to them (self-report);
- reporting the occurrence of at least two intrusive memories of a work-related traumatic incident in the week prior to beginning the study;
- able and willing to talk about the intrusive memories;
Show all 9Show fewer
- able and willing to complete an electronic Intrusion Diary over a 2-3 week period;
- able and willing to play Tetris on a hand-held device;
- not currently undergoing treatment for PTSD or its symptoms.
Who cannot join
- participants will be excluded if they have fewer than two targeted intrusive memories per week during the pre-intervention period;
- participants will be also excluded if they start undergoing treatment for PTSD or its symptoms during the course of the study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
South Central Ambulance Service NHS Foundation Trust
Bicester
Oxford University Hospitals NHS Foundation Trust
Oxford
Royal Berkshire NHS Foundation Trust
Reading
About this study
Official title: Reducing Intrusive Memories of Work-Related Traumatic Events, Including Events During the COVID-19 Pandemic, in NHS Staff Using a Brief Cognitive Task Intervention
During the COVID-19 pandemic, clinical staff working in frontline NHS hospital and pre-hospital departments (e.g. emergency department, intensive care unit, ambulance service) are being faced with difficult and stressful situations, which may be traumatic to them. Staff report high rates of post-traumatic stress symptoms, such as intrusive memories of these incidents, which 'pop into their mind' unexpectedly, are distressing and can impact on work performance. Currently there is a lack of tailored evidence-based interventions for staff struggling with intrusive memories of work-related traumatic events: simple, accessible, remotely-delivered interventions are needed. An intervention which has been found to be effective in reducing intrusive memories is a simple cognitive task that involves briefly bringing to mind the memory and then playing the computer game Tetris with specific ("mental rotation") instructions. This case series study aims to test the intervention in a group of 8-20 staff members working clinically in NHS hospital and pre-hospital departments. The intervention will be delivered remotely (via computer/smartphone/tablet/phone). Participants will record the number of intrusive memories daily over a 3-week period, with the intervention delivered after 1 week (with optional subsequent booster sessions). Symptoms of trauma, anxiety and depression will be assessed weekly over this period, and at 4 weeks after the intervention. It is predicted that participants will have fewer intrusive memories per day/week, and lower clinical symptoms scores, after completing the intervention than before completing the intervention. The study will also investigate how feasible and acceptable the intervention is for NHS staff. Findings will inform the next steps in developing and evaluating a digital intervention to reduce intrusive memories of work-related traumatic events in healthcare staff.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Simple cognitive task
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple cognitive taskBehavioural
A brief memory reminder cue followed by playing the computer game Tetris for 25 minutes using mental rotation instructions. Option for subsequent booster sessions (self-administered/researcher-assisted).
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task | Experimental | A brief memory reminder cue followed by playing the computer game Tetris for 25 minutes using mental rotation instructions. Option for subsequent booster sessions (self-administered/researcher-assisted). Receives: Behavioral: Simple cognitive task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of intrusive memories of traumatic event
Number of intrusive memories of traumatic event recorded by participants in a brief electronic daily diary.
Measured: Change from baseline to post-intervention, in line with case series design. The baseline period and the post-intervention period were defined separately for each intrusive memory, according to when that intrusion was first targeted with the intervention.
Secondary outcomes (6)
Changes in ratings of intrusive memory characteristics
A bespoke self-report measure assessing ratings of intrusive memory vividness, distress (0 = not at all, 10 = extremely), duration of bothersomeness (<1 min to >60 mins), and the impact of intrusive memories on sleep (very good to very bad), concentration and disruption of task at hand (0 = not at all; 10 = a great deal), per intrusive memory reported in the brief daily diary (high scores indicating greater impact/difficulties).
Participants are also asked to record whether they were at work when they had the intrusive memory (yes/no), the approximate time the intrusive memory popped into their mind (open-ended response), how many times they used the Tetris intervention since the last diary entry (open-ended response), and how accurately they think they completed the diary (0 = not at all accurately; 10 = extremely accurately).
Measured: Change between baseline and post-intervention, in line with case series design
Impact of Events Scale-Revised score (IES-R; Weiss & Marmar, 1997)
The IES-R is a self-report measure with three subscales (intrusion, avoidance and hyperarousal) which is used to assess subjective distress experienced after traumatic events. It consists of 22 items, each on a scale ranging from 0 ("not at all") to 4 ("extremely") related to how distressing each item has been during the past week. A total maximum score is 88. Higher scores represent worse outcome.
Measured: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Patient Health Questionnaire Depression scale (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
The PHQ-9 is a brief self-report measure of depression symptoms and their severity. It consists of nine items that are rated on a 4-point Likert-type scale, ranging from 0 ("not at all") to 3 ("nearly every day"). The total maximum score is 27. Higher scores represent worse outcome.
Measured: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Generalised Anxiety Disorder scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006)
The GAD-7 is a brief self-report measure of symptoms of general anxiety disorder (GAD) and their severity. It consists of seven items that are rated on a 4-point Likert-type scale, ranging from 0 ("not at all") to 3 ("nearly every day"). The total maximum score is 21. Higher scores represent worse outcome.
Measured: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989)
The PSQI (Buysse, 1989) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of nine questions, which produce one global score. Higher scores represent worse outcome.
Measured: At 1 week pre-intervention, and at 4 weeks post-intervention
Change in retrospective ratings of intrusive memory characteristics over the last week
A 10-item bespoke questionnaire assessing ratings of intrusive memories retrospectively over the last week (frequency, vividness, distress, impact on concentration, task disruption, interference with night's sleep, impact on daily functioning, and duration of bothersomeness). Six questions are rated on an 11-point scale from 0 ("not at all") to 10 ("a great deal") (high scores indicating greater impact/difficulties): e.g. How much did they disrupt your concentration?; How much have your intrusive memories affected your ability to function in your daily life? Two questions are rated using discrete categories: approximately how long did the intrusive memory bother you for? (6 time categories from <1 min to >60 mins); over the last week, how many intrusive memories did you have? (7 categories from 'none (0)' to 'more (more than 50'). One question is open-ended: how have your intrusive memories affected your ability to function in your daily life in the past week? (open-ended response)
Measured: At 1 week pre-intervention, and at 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start4 Jun 2020
- Primary completion16 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Royal Berkshire NHS Foundation Trust, South Central Ambulance Service NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Craig Steel, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769999
- Sponsor's protocol ID
- R64738/RE001
- Acronym
- CALM-ED
- Status last verified
- Dec 2020
- First submitted
- 13 Jul 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kubickova V, Steel C, Moulds ML, Kanstrup M, Beer S, Darwent M, Keating L, Holmes EA, Iyadurai L. Reducing the Number of Intrusive Memories of Work-Related Traumatic Events in Frontline Health Care Staff During the COVID-19 Pandemic: Case Series. JMIR Hum Factors. 2024 Nov 18;11:e55562. doi: 10.2196/55562.
PubMed 39556801
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Intrusive Memories of Work-Related Traumatic Events, Including Events During the COVID-19 Pandemic, in NHS Staff Using a Brief Cognitive Task Intervention
- ClinicalTrials.gov ID
- NCT04769999
- Acronym / sponsor ID
- CALM-ED / R64738/RE001
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Royal Berkshire NHS Foundation Trust, South Central Ambulance Service NHS Foundation Trust
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the COVID-19 pandemic, clinical staff working in frontline NHS hospital and pre-hospital departments (e.g. emergency department, intensive care unit, ambulance service) are being faced with difficult and stressful situations, which may be traumatic to them. Staff report high rates of post-traumatic stress symptoms, such as intrusive memories of these incidents, which 'pop into their mind' unexpectedly, are distressing and can impact on work performance. Currently there is a lack of tailored evidence-based interventions for staff struggling with intrusive memories of work-related traumatic events: simple, accessible, remotely-delivered interventions are needed. An intervention which has been found to be effective in reducing intrusive memories is a simple cognitive task that involves briefly bringing to mind the memory and then playing the computer game Tetris with specific ("mental rotation") instructions. This case series study aims to test the intervention in a group of 8-20 staff members working clinically in NHS hospital and pre-hospital departments. The intervention will be delivered remotely (via computer/smartphone/tablet/phone). Participants will record the number of intrusive memories daily over a 3-week period, with the intervention delivered after 1 week (with optional subsequent booster sessions). Symptoms of trauma, anxiety and depression will be assessed weekly over this period, and at 4 weeks after the intervention. It is predicted that participants will have fewer intrusive memories per day/week, and lower clinical symptoms scores, after completing the intervention than before completing the intervention. The study will also investigate how feasible and acceptable the intervention is for NHS staff. Findings will inform the next steps in developing and evaluating a digital intervention to reduce intrusive memories of work-related traumatic events in healthcare staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task | Experimental | Behavioral: Simple cognitive taskA brief memory reminder cue followed by playing the computer game Tetris for 25 minutes using mental rotation instructions. Option for subsequent booster sessions (self-administered/researcher-assisted). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 18 or above;
- able to read, write and speak in English;
- able and willing to provide informed consent and complete study procedures;
- NHS hospital and pre-hospital clinical staff; experiencing intrusive memories, which are problematic to them (self-report);
- reporting the occurrence of at least two intrusive memories of a work-related traumatic incident in the week prior to beginning the study;
Key exclusion criteria (2 listed)
- participants will be excluded if they have fewer than two targeted intrusive memories per week during the pre-intervention period;
- participants will be also excluded if they start undergoing treatment for PTSD or its symptoms during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple cognitive taskA brief memory reminder cue followed by playing the computer game Tetris for 25 minutes using mental rotation instructions. Option for subsequent booster sessions (self-administered/researcher-assisted). | Behavioural | Simple cognitive task |
Primary outcome
Change in the number of intrusive memories of traumatic event
Time frame: Change from baseline to post-intervention, in line with case series design. The baseline period and the post-intervention period were defined separately for each intrusive memory, according to when that intrusion was first targeted with the intervention.
Number of intrusive memories of traumatic event recorded by participants in a brief electronic daily diary.
6 secondary outcomes
Changes in ratings of intrusive memory characteristics
Time frame: Change between baseline and post-intervention, in line with case series design
Impact of Events Scale-Revised score (IES-R; Weiss & Marmar, 1997)
Time frame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Patient Health Questionnaire Depression scale (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Generalised Anxiety Disorder scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006)
Time frame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989)
Time frame: At 1 week pre-intervention, and at 4 weeks post-intervention
Change in retrospective ratings of intrusive memory characteristics over the last week
Time frame: At 1 week pre-intervention, and at 4 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 39556801Kubickova V, Steel C, Moulds ML, Kanstrup M, Beer S, Darwent M, Keating L, Holmes EA, Iyadurai L. Reducing the Number of Intrusive Memories of Work-Related Traumatic Events in Frontline Health Care Staff During the COVID-19 Pandemic: Case Series. JMIR Hum Factors. 2024 Nov 18;11:e55562. doi: 10.2196/55562.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Steel principal investigator
University of Oxford
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple cognitive task in people with Post Traumatic Stress Disorder, run by University of Oxford at 3 sites in United Kingdom.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of intrusive memories of traumatic event (time frame: Change from baseline to post-intervention, in line with case series design. The baseline period and the post-intervention period were defined separately for each intrusive memory, according to when that intrusion was first targeted with the intervention.). 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 NCT04769999, which also lists 1 linked publication.
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 25 Feb 2021.