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Computer Assisted Lessening of Intrusive Memories in the Emergency Department (CALM-ED)

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Simple cognitive task
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Central Ambulance Service NHS Foundation Trust
  • Oxford University Hospitals NHS Foundation Trust
  • Royal Berkshire NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simple cognitive task

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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)

Full Information

First Posted
July 13, 2020
Last Updated
February 22, 2021
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Royal Berkshire NHS Foundation Trust, South Central Ambulance Service NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04769999
Brief Title
Computer Assisted Lessening of Intrusive Memories in the Emergency Department
Acronym
CALM-ED
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Royal Berkshire NHS Foundation Trust, South Central Ambulance Service NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple cognitive task
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Simple cognitive task
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in the number of intrusive memories of traumatic event
Description
Number of intrusive memories of traumatic event recorded by participants in a brief electronic daily diary.
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.
Secondary Outcome Measure Information:
Title
Changes in ratings of intrusive memory characteristics
Description
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).
Time Frame
Change between baseline and post-intervention, in line with case series design
Title
Impact of Events Scale-Revised score (IES-R; Weiss & Marmar, 1997)
Description
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.
Time Frame
Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
Title
The Patient Health Questionnaire Depression scale (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Description
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.
Time Frame
Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
Title
The Generalised Anxiety Disorder scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006)
Description
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.
Time Frame
Weekly for 6 weeks: 2 weeks pre-intervention to 4 weeks post-intervention
Title
The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989)
Description
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.
Time Frame
At 1 week pre-intervention, and at 4 weeks post-intervention
Title
Change in retrospective ratings of intrusive memory characteristics over the last week
Description
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)
Time Frame
At 1 week pre-intervention, and at 4 weeks post-intervention
Other Pre-specified Outcome Measures:
Title
Within-intervention session measure: change in subjective level of arousal
Description
Bespoke 11-point Likert-type rating scale (0 = calm to 10 = maximum arousal) was used to assess subjective level of arousal at three time points during the intervention procedure.
Time Frame
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.
Title
Feedback questionnaire
Description
11-item Feedback Questionnaire assessing participant experience of the intervention including ratings of how easy, helpful and burdensome they found the intervention, and open-ended questions about their experience of the intervention.
Time Frame
At 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Steel
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Central Ambulance Service NHS Foundation Trust
City
Bicester
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
Country
United Kingdom
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Computer Assisted Lessening of Intrusive Memories in the Emergency Department

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