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

February 28, 2023 updated by: University Hospital Southampton NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Group sessions with psychological therapists
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility 1 - Recruitment
Time Frame: 1 month post-recruitment end date
Recruitment of at least 5 participants per month per site
1 month post-recruitment end date
Feasibility 2 - Protocol fidelity
Time Frame: 1 month post-intervention final session
Adherence to >75% of protocol interventions
1 month post-intervention final session
Feasibility 3 - Blinded outcome assessments
Time Frame: 6 months post-intervention
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.
6 months post-intervention
Feasibility 4 - Participant retention
Time Frame: 6 months post-intervention
Participant retention to study completion
6 months post-intervention
Feasibility 5 - Acceptability of intervention
Time Frame: Between 6 and 12 months post-intervention
Acceptability of intervention and assessments which will be assessed through the use of questionnaires and focus groups.
Between 6 and 12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental wellbeing
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention
Post-traumatic stress disorder
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention
Anxiety
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention
Depression
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention
Quality of life EQ-5D-5L
Time Frame: Baseline, 6 months post-intervention
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).
Baseline, 6 months post-intervention
Resilience
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention
Burnout syndrome
Time Frame: Baseline, 6 months post-intervention
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.
Baseline, 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Investigators

  • Principal Investigator: Andy Bates, University Hospital Southampton NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI0412

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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