A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)

Intrusive Memories of Traumatic Event(s) Clinical Trial

— GAINS  

Official title:

A Randomised Optimisation Study of a Brief Digital Imagery-competing Task Intervention to Support NHS ICU Staff Experiencing Intrusive Memories of Traumatic Events From Working in the COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992390
• Other study ID #: P1V-GAINS-IN01
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2023
• Source: P1vital Products Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intensive care unit (ICU) staff are frequently exposed to traumatic events at work (e.g., witnessing patients die), amplified by the COVID-19 pandemic. A significant proportion experience intrusive memories of these events that pop suddenly into mind: these imagery-based memories can disrupt functioning and contribute to posttraumatic stress disorder. Previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories after a traumatic event. In this study we aim to optimise a brief digital intervention to help reduce the number of intrusive memories experienced by ICU staff (primary outcome). We will explore if it can improve work functioning and wellbeing (secondary outcomes). We will recruit approximately 150 ICU staff with intrusive memories of events experienced during the COVID-19 pandemic.

The study is funded by the Wellcome Trust (223016/Z/21/Z).

Description:

A statistical analysis plan will be prepared prior to the first interim analysis for the outcomes that will guide study optimisation, i.e., primarily the primary outcome.

A second statistical analysis plan will be prepared prior to the end of the study, to outline the standard (frequentist) statistical approaches that will be used to analyse the primary, secondary and tertiary data.

Regular monitoring will be performed by P1vital Products to verify that the study is conducted and data are generated, documented and reported in compliance with the protocol, GCP and the applicable regulatory requirements.

Quality assurance representatives from the Sponsor may carry out an audit of the study in compliance with regulatory guidelines and relevant standard operating procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Aged 18 or above.

• Able to read, write and speak in English.

• Worked in a clinical role in an NHS Intensive Care Unit or equivalent during the COVID-19 pandemic (e.g. as a member of ICU staff or deployed to work in the ICU during the pandemic)

• Experienced at least one traumatic event related to their work during the COVID-19 pandemic, meeting criterion A of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for Post-Traumatic Stress Disorder (PTSD): "exposure to actual or threatened death, serious injury, or sexual violence" by "directly experiencing the traumatic event(s)" or "witnessing, in person, the event(s) as it occurred to others"

• Experience intrusive memories of the traumatic event(s).

• Experienced at least three intrusive memories in the week prior to screening.

• Have internet access.

• Willing and able to provide informed consent and complete study procedures (including briefly listing their intrusive memories (without going into any detail), and playing the brief digital imagery-competing task with particular mental rotation instructions, and completing an online intrusive memory diary).

• Willing and able to be contacted by the research team during the study period.

Exclusion criteria:

• Have fewer than three intrusive memories during the run-in week.

We will not exclude those undergoing other treatment for PTSD or its symptoms, so the study is as inclusive as possible to meet the challenges ICU staff are facing during the COVID-19 pandemic.

Related Conditions & MeSH terms

• Intrusive Memories of Traumatic Event(s)

Intervention

Behavioral:
• Brief digital imagery-competing task intervention
First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring).

Locations

Country	Name	City	State
United Kingdom	P1vital Products Limited	Wallingford	Oxfordshire

Sponsors (5)

Lead Sponsor	Collaborator
P1vital Products Limited	Intensive Care Society, University of Nottingham, Uppsala University, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Iyadurai L, Highfield J, Kanstrup M, Markham A, Ramineni V, Guo B, Jaki T, Kingslake J, Goodwin GM, Summers C, Bonsall MB, Holmes EA. Reducing intrusive memories after trauma via an imagery-competing task intervention in COVID-19 intensive care staff: a randomised controlled trial. Transl Psychiatry. 2023 Sep 1;13(1):290. doi: 10.1038/s41398-023-02578-0. — View Citation

Ramineni V, Millroth P, Iyadurai L, Jaki T, Kingslake J, Highfield J, Summers C, Bonsall MB, Holmes EA. Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Support from managers and from family/friends	The 2 item questionnaire asks "During the COVID-19 pandemic, how well supported have you been by your supervisors/managers?" and "how well supported have you been by your family and friends?" The response is rated as "not at all", "quite a bit", "moderately", "quite a bit", or "extremely"	Baseline
Other	Changes to health and work	The 6-item questionnaire questionnaire will be used to assess the occurrence of any new traumatic events, any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment.	4 weeks and 8 weeks (both arms)
Other	Optimisation Assessment	Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed.	Baseline, 4 weeks and 8 weeks
Other	Feedback questionnaire	The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the intervention, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within NHS ICUs, each rated from 0 (not at all) to 10 (very). The last two items ask how the intervention could be improved, for any other comments or suggestions about the intervention, and for the occurrence of any adverse events, all with an open response.	Week 4 (immediate intervention arm), Week 8 (delayed intervention arm)
Other	Optional qualitative interview	Qualitative interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the intervention, including acceptability, improvement suggestions, training/psychoeducation materials, potential barriers/facilitators to recruitment and uptake, and support needed for remote intervention delivery.	Week 5 (immediate intervention arm), Week 9 (delayed intervention arm)
Primary	Number of intrusive memories of traumatic event(s)	Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.	Week 4 (both arms) and Controlling for Run in week (both arms)
Secondary	Number of intrusive memories of traumatic event(s)	Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.; Total number of intrusive memories reported in Week 4 compared to baseline for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (within-group comparisons).	Run-in week (immediate intervention arm) , week 4 (both arms) and week 8 (delayed intervention arm)
Secondary	Intrusive memory ratings	The 9-item questionnaire assesses a number of intrusive memories characteristics. These characteristics include frequency (7-point categorical response from 'never' to 'many times a day); distress (0=not at all to 10=extremely); disruption to concentration (0=not at all to 10=extremely); interference with what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '+60mins')); impact on work functioning (0=not at all to 10=extremely) and in what ways (open text response)); impact on functioning in other areas of life (how much (0= not at all to 10 = extremely) and in what ways (open text response)).	Baseline, 4 weeks and 8 weeks
Secondary	Impact of Event Scale-Revised (IES-R)	This 22-item questionnaire assesses subjective distress after a traumatic event (with reference to the events for which participants are taking part in the study).; Items are rated for how distressing they have been during the past 7 days on a 5- point scale ranging from 0 ("not at all") to 4 ("extremely"). Scores are calculated for the intrusion, avoidance and hyperarousal subscales and total score. We will analyse total score (mean of all 22 items) and subscales separately (mean of items in each subscale).	Baseline, 4 weeks and 8 weeks
Secondary	PTSD Checklist for DSM-5 (PCL-5) 4-item version	This shortened 4-item version of the PCL-5 assesses symptoms of PTSD over the last month.; Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranges from 0 to 16 (cut-off for possible PTSD is 10 or above).	Baseline, 4 weeks and 8 weeks
Secondary	Sleep Condition Indicator (SCI)	This 8-item scale measures sleep problems against the DSM-5 criteria for insomnia disorder.; Item responses are each scored 0-4, with scores from 0 to 2 indicating threshold criteria for insomnia disorder. Total score ranges 0-32, with a higher score indicating better sleep (cut-off for possible insomnia disorder is a total score from 0 to 2).	Baseline, 4 weeks and 8 weeks
Secondary	Generalised Anxiety Disorder 2-item scale (GAD-2)	Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible GAD is 3 or above).	Baseline, 4 weeks and 8 weeks
Secondary	Patient Health Questionnaire 2-item version (PHQ-2)	This 2-item short-form self-report measure assesses symptoms of depression.; Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible major depressive disorder is 3 or above).	Baseline, 4 weeks and 8 weeks
Secondary	Psychological Outcome Profiles (PSYCHLOPS)	This measure consists of 4 questions that are scored and designed to assess the impact of a person's intrusive memories.; Questions 1b, 2b, 3b, and 4 are scored. These have a six-point ordinal scale ranging from 0 to 5 and are summed to generate a total score from 0 to 20. Higher values indicate the person is more severely affected.	Baseline, 4 weeks and 8 weeks
Secondary	World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0)	The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.; Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points).	Baseline, 4 weeks and 8 weeks
Secondary	5-level European Quality of Life 5 Dimension (EQ-5D-5L)	The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.; Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale. 5 items are scored on a 5-point ordinal scale from 'no problem' (1) to 'highest level of problems' (5). Respondents also rate their overall health today from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed).	Baseline, 4 weeks and 8 weeks
Secondary	Scale of Work Engagement and Burnout (SWEBO)	This 18-item self-report measure assesses work engagement and burnout.; The work engagement subscale consists of 9 items assessing three dimensions (vigour, attentiveness, dedication). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The mean score is calculated for two subscales: engagement and burnout (9 items each).	Baseline, 4 weeks and 8 weeks
Secondary	Sickness absence	Single item assessing self-reported number of sick days taken from work in the last 4 weeks. Total scoring includes total number of sick days.	Baseline, 4 weeks and 8 weeks
Secondary	Intention to leave job	This 3 items questionnaire is used to assess participants' intention to leave their job e.g. "I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree). The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.	Baseline, 4 weeks and 8 weeks
Secondary	Weekly Work Pattern	Two items asses the number of days worked and number of night shifts worked in the last week (both with responses from 0 to 7). Items are examine separately (not summed).	Baseline, 4 weeks and 8 weeks

External Links

•   Published paper of primary outcome results (Bayesian analysis)
•   Published paper of primary outcome results (Frequentist analysis)