Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05087186
Status:
RECRUITING
Last Update Posted:
2023-03-01
First Post:
2021-10-18
Brief Title:
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic The PROACTIVE Feasibility Trial
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic The PROACTIVE Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None