Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial

NCT ID: NCT05087186

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Psychological Burnout Post Traumatic Stress Disorder Anxiety Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group sessions with psychological therapists

Group Type EXPERIMENTAL

Guided imagery and FLASH technique

Intervention Type BEHAVIORAL

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

Interventions

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Guided imagery and FLASH technique

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andy Bates

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

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University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Andy Bates

Role: CONTACT

02381206317

Hannah Golding

Role: CONTACT

Facility Contacts

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Hannah Golding

Role: primary

Other Identifiers

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CRI0412

Identifier Type: -

Identifier Source: org_study_id

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