Clinical trial NCT04769999: Computer Assisted Lessening of Intrusive Memories in the Emergency Department
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: Royal Berkshire NHS Foundation Trust
name: South Central Ambulance Service NHS Foundation Trust
First posted: 2021-02-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the number of intrusive memories of traumatic event
timeFrame: 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:
measure: Changes in ratings of intrusive memory characteristics
timeFrame: Change between baseline and post-intervention, in line with case series design
measure: Impact of Events Scale-Revised score (IES-R; Weiss & Marmar, 1997)
timeFrame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
measure: The Patient Health Questionnaire Depression scale (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
timeFrame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
measure: The Generalised Anxiety Disorder scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006)
timeFrame: Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
measure: The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989)
timeFrame: At 1 week pre-intervention, and at 4 weeks post-intervention
measure: Change in retrospective ratings of intrusive memory characteristics over the last week
timeFrame: At 1 week pre-intervention, and at 4 weeks post-intervention
Other outcomes:
measure: Within-intervention session measure: change in subjective level of arousal
timeFrame: Change in arousal from prior to administering part I of the intervention to after completing part I of the intervention, and then from completing part I of the intervention to after completing part II of the intervention.
measure: Feedback questionnaire
timeFrame: At 4 weeks post-intervention
Locations:
city: Bicester
country: United Kingdom
facility: South Central Ambulance Service NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
Study officials:
affiliation: University of Oxford
name: Craig Steel
role: PRINCIPAL_INVESTIGATOR
References: