Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
Primary Purpose
Psychological, Burnout, Post Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Guided imagery and FLASH technique
Sponsored by
About this trial
This is an interventional treatment trial for Psychological focused on measuring Critical Care, Intensive Care, Staff Wellbeing, Guided Imagery, FLASH technique
Eligibility Criteria
Inclusion Criteria:
- Intensive care nursing staff with experience of caring for critically ill patients with serious SARS-CoV2 infection
Exclusion Criteria:
- Currently receiving psychological support/treatment
- Pre-existing diagnosis of psychosis
- 'Reservist' nursing staff who were drafted in to look after ICU patients during the Covid-19 pandemic, but normally work elsewhere
Sites / Locations
- University Hospital Southampton NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Group sessions with psychological therapists
Outcomes
Primary Outcome Measures
Feasibility 1 - Recruitment
Recruitment of at least 5 participants per month per site
Feasibility 2 - Protocol fidelity
Adherence to >75% of protocol interventions
Feasibility 3 - Blinded outcome assessments
Completed blinded outcome assessments in >75% of participants (by questionnaire). This will be calculated as a percentage of how many participants complete the questionnaire pack versus how many are enrolled on the trial.
Feasibility 4 - Participant retention
Participant retention to study completion
Feasibility 5 - Acceptability of intervention
Acceptability of intervention and assessments which will be assessed through the use of questionnaires and focus groups.
Secondary Outcome Measures
Mental wellbeing
Warwick-Edinburgh Mental Wellbeing Scale - WEMWBS. Respondents rate items based on how often they have had the thought or feeling over the last two weeks, from 1 'not at all' to 5 'all of the time'. Total score is the sum of all items and ranges from 14-70. The higher the score, the higher the level of mental wellbeing.
Post-traumatic stress disorder
PTSD checklist - PCL-5. A 20 item self-report measure to 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 80. A score of between 31-33 or above is indicative of probable PTSD.
Anxiety
Generalised Anxiety Disorder-7 - GAD-7. 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 all items and ranges from 0 to 15. Scores of 5, 10, and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Depression
Patient Health Questionnaire-9 - PHQ-9. This 9-item 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 27. Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Quality of life EQ-5D-5L
EuroQol Five Dimension- Five level scale - 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).
Resilience
Brief Resilience Scale - BRS. 6 items are scored on a 5-point ordinal scale from 'strongly disagree' to 'strongly agree', with reversing scores assigned to alternating questions. The scores for all 6 items are summed (giving a range from 6-30) and then divided by the total number of questions answered to give a final score.
Burnout syndrome
Maslach Burnout Inventory - MBI. 22 statements of job-related feelings for which respondents are asked the frequency to which they feel this way about their job ranging from 0 'never' to 6 'every day'. Each statement relates to one of three dimensions of burnout; emotional exhaustion, depersonalization and personal accomplishment. Each dimension is scored by summing the answer for that section and dividing by the number of items answered. Possible scores range as follows; EE 0-54, D 0-30 and PA 0-40, with a higher score associated with a higher level of burnout.
Full Information
NCT ID
NCT05087186
First Posted
October 18, 2021
Last Updated
February 28, 2023
Sponsor
University Hospital Southampton NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05087186
Brief Title
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
Official Title
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The psychological health of frontline healthcare workers, caring for critically ill patients with COVID-19, has deteriorated during the pandemic. Nurses appear to be most seriously affected. Despite the availability of supportive interventions, uptake is poor, and none have been found beneficial in randomised controlled trials.
The investigators have developed a two-pronged approach (combining the FLASH technique and Guided Imagery) that aims to reduce existing symptoms of distress and provide participants with techniques to help them cope with future stressful events. This approach has been developed with experienced psychological practitioners, and staff members. The FLASH technique is a recently developed therapy which aims to reduce psychological distress following traumatic events. It allows participants to process traumatic memories without feeling distress. Using guided imagery, a trained psychological practitioner helps participants to direct attention from distressing or intrusive memories, by evoking or generating positive mental images, sounds, tastes, smells and movement. Emerging evidence suggests that both techniques are safe and effective.
PROACTIVE will investigate the feasibility and acceptability of this two-pronged approach to address existing traumatic symptoms and enhance future resilience for intensive care nurses. Findings will inform the design of a larger trial which tests intervention effectiveness.
Detailed Description
Nursing staff from critical care units within three Trusts will be approached, given information regarding the study, and invited to participate. Nurses who wish to take part will complete a consent form and a baseline range of psychological questionnaires. They will then be asked to join our group sessions; two guided imagery training sessions to enhance resilience; two therapy sessions, using the Flash Technique, to address symptoms of distress; and a final follow-up session to consolidate techniques learnt. Sessions will be delivered online, in four groups of ten staff. Recruitment will continue until the 40 intervention slots have been filled. Six months after the first intervention session, participants will be asked to repeat the range of psychological questionnaires, to help us understand whether the intervention helped to reduce psychological distress.
The investigators will report recruitment and adherence rates and collect preliminary data regarding the effectiveness of the intervention. The investigators will also undertake a process evaluation, to examine acceptability and give participants a chance to report their experience of the study.
Results will inform the design of a subsequent multi-centre trial investigating the effectiveness of the intervention in improving the mental wellbeing of intensive care nurses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological, Burnout, Post Traumatic Stress Disorder, Anxiety, Depression
Keywords
Critical Care, Intensive Care, Staff Wellbeing, Guided Imagery, FLASH technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Group sessions with psychological therapists
Intervention Type
Behavioral
Intervention Name(s)
Guided imagery and FLASH technique
Intervention Description
Five virtual group sessions delivered by psychological therapists;
Sessions 1 and 2: Guided imagery
Sessions 3 and 4: FLASH technique
Session 5: Refresher on guided imagery and FLASH technique
Primary Outcome Measure Information:
Title
Feasibility 1 - Recruitment
Description
Recruitment of at least 5 participants per month per site
Time Frame
1 month post-recruitment end date
Title
Feasibility 2 - Protocol fidelity
Description
Adherence to >75% of protocol interventions
Time Frame
1 month post-intervention final session
Title
Feasibility 3 - Blinded outcome assessments
Description
Completed blinded outcome assessments in >75% of participants (by questionnaire). This will be calculated as a percentage of how many participants complete the questionnaire pack versus how many are enrolled on the trial.
Time Frame
6 months post-intervention
Title
Feasibility 4 - Participant retention
Description
Participant retention to study completion
Time Frame
6 months post-intervention
Title
Feasibility 5 - Acceptability of intervention
Description
Acceptability of intervention and assessments which will be assessed through the use of questionnaires and focus groups.
Time Frame
Between 6 and 12 months post-intervention
Secondary Outcome Measure Information:
Title
Mental wellbeing
Description
Warwick-Edinburgh Mental Wellbeing Scale - WEMWBS. Respondents rate items based on how often they have had the thought or feeling over the last two weeks, from 1 'not at all' to 5 'all of the time'. Total score is the sum of all items and ranges from 14-70. The higher the score, the higher the level of mental wellbeing.
Time Frame
Baseline, 6 months post-intervention
Title
Post-traumatic stress disorder
Description
PTSD checklist - PCL-5. A 20 item self-report measure to 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 80. A score of between 31-33 or above is indicative of probable PTSD.
Time Frame
Baseline, 6 months post-intervention
Title
Anxiety
Description
Generalised Anxiety Disorder-7 - GAD-7. 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 all items and ranges from 0 to 15. Scores of 5, 10, and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Time Frame
Baseline, 6 months post-intervention
Title
Depression
Description
Patient Health Questionnaire-9 - PHQ-9. This 9-item 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 27. Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time Frame
Baseline, 6 months post-intervention
Title
Quality of life EQ-5D-5L
Description
EuroQol Five Dimension- Five level scale - 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).
Time Frame
Baseline, 6 months post-intervention
Title
Resilience
Description
Brief Resilience Scale - BRS. 6 items are scored on a 5-point ordinal scale from 'strongly disagree' to 'strongly agree', with reversing scores assigned to alternating questions. The scores for all 6 items are summed (giving a range from 6-30) and then divided by the total number of questions answered to give a final score.
Time Frame
Baseline, 6 months post-intervention
Title
Burnout syndrome
Description
Maslach Burnout Inventory - MBI. 22 statements of job-related feelings for which respondents are asked the frequency to which they feel this way about their job ranging from 0 'never' to 6 'every day'. Each statement relates to one of three dimensions of burnout; emotional exhaustion, depersonalization and personal accomplishment. Each dimension is scored by summing the answer for that section and dividing by the number of items answered. Possible scores range as follows; EE 0-54, D 0-30 and PA 0-40, with a higher score associated with a higher level of burnout.
Time Frame
Baseline, 6 months post-intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Intensive care nursing staff with experience of caring for critically ill patients with serious SARS-CoV2 infection
Exclusion Criteria:
Currently receiving psychological support/treatment
Pre-existing diagnosis of psychosis
'Reservist' nursing staff who were drafted in to look after ICU patients during the Covid-19 pandemic, but normally work elsewhere
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Bates
Phone
02381206317
Email
a.bates@soton.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Golding
Email
hannah.golding@uhs.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Bates
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Golding
Email
hannah.golding@uhs.nhs.uk
12. IPD Sharing Statement
Learn more about this trial
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
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