Clinical trial NCT05087186: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological
Burnout
Post Traumatic Stress Disorder
Anxiety
Depression
Keywords: Critical Care
Intensive Care
Staff Wellbeing
Guided Imagery
FLASH technique
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility 1 - Recruitment
timeFrame: 1 month post-recruitment end date
measure: Feasibility 2 - Protocol fidelity
timeFrame: 1 month post-intervention final session
measure: Feasibility 3 - Blinded outcome assessments
timeFrame: 6 months post-intervention
measure: Feasibility 4 - Participant retention
timeFrame: 6 months post-intervention
measure: Feasibility 5 - Acceptability of intervention
timeFrame: Between 6 and 12 months post-intervention
Secondary outcomes:
measure: Mental wellbeing
timeFrame: Baseline, 6 months post-intervention
measure: Post-traumatic stress disorder
timeFrame: Baseline, 6 months post-intervention
measure: Anxiety
timeFrame: Baseline, 6 months post-intervention
measure: Depression
timeFrame: Baseline, 6 months post-intervention
measure: Quality of life EQ-5D-5L
timeFrame: Baseline, 6 months post-intervention
measure: Resilience
timeFrame: Baseline, 6 months post-intervention
measure: Burnout syndrome
timeFrame: Baseline, 6 months post-intervention
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Andy Bates
role: PRINCIPAL_INVESTIGATOR
References: