NCT04769999

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

June 4, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
Last Updated

February 25, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

July 13, 2020

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Change between baseline and post-intervention, in line with case series design

  • Impact of Events Scale-Revised score (IES-R; Weiss & Marmar, 1997)

    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)

    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)

    Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention

  • The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989)

    At 1 week pre-intervention, and at 4 weeks post-intervention

  • +1 more secondary outcomes

Other Outcomes (2)

  • Within-intervention session measure: change in subjective level of arousal

    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.

  • Feedback questionnaire

    At 4 weeks post-intervention

Study Arms (1)

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).

Behavioral: Simple cognitive task

Interventions

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).

Simple cognitive task

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

South Central Ambulance Service NHS Foundation Trust

Bicester, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Craig Steel

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

February 25, 2021

Study Start

June 4, 2020

Primary Completion

October 16, 2020

Study Completion

October 30, 2020

Last Updated

February 25, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations