PsychologicalNCT05087186
Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
A study testing Guided imagery and FLASH technique in people with Psychological and Burnout, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological, Burnout, Post Traumatic Stress Disorder
- What is being tested?
- Guided imagery and FLASH technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Intensive care nursing staff with experience of caring for critically ill patients with serious SARS-CoV2 infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hannah Golding contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton
Hannah Golding, hannah.golding@uhs.nhs.uk
About this study
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.
Read the 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.
- Conditions
- Psychological, Burnout, Post Traumatic Stress Disorder, Anxiety, Depression
- Being tested
- Guided imagery and FLASH technique
- Keywords
- Critical Care, Intensive Care, Staff Wellbeing, Guided Imagery, FLASH technique
- Medical subject headings
- Burnout, Psychological, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imagery and FLASH techniqueBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group sessions with psychological therapists Receives: Behavioral: Guided imagery and FLASH technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility 1 - Recruitment
Recruitment of at least 5 participants per month per site
Measured: 1 month post-recruitment end date
Feasibility 2 - Protocol fidelity
Adherence to >75% of protocol interventions
Measured: 1 month post-intervention final session
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.
Measured: 6 months post-intervention
Feasibility 4 - Participant retention
Participant retention to study completion
Measured: 6 months post-intervention
Feasibility 5 - Acceptability of intervention
Acceptability of intervention and assessments which will be assessed through the use of questionnaires and focus groups.
Measured: Between 6 and 12 months post-intervention
Secondary outcomes (7)
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.
Measured: Baseline, 6 months post-intervention
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.
Measured: Baseline, 6 months post-intervention
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.
Measured: Baseline, 6 months post-intervention
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.
Measured: Baseline, 6 months post-intervention
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).
Measured: Baseline, 6 months post-intervention
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.
Measured: Baseline, 6 months post-intervention
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.
Measured: Baseline, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start13 Jan 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andy Bates, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087186
- Sponsor's protocol ID
- CRI0412
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Support for Intensive Care Nurses During the COVID-19 Pandemic: The PROACTIVE Feasibility Trial
- ClinicalTrials.gov ID
- NCT05087186
- Acronym / sponsor ID
- CRI0412
- Conditions
- Psychological, Burnout, Post Traumatic Stress Disorder, Anxiety, Depression
- Keywords
- Critical Care, Intensive Care, Staff Wellbeing, Guided Imagery, FLASH technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Guided imagery and FLASH techniqueGroup sessions with psychological therapists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intensive care nursing staff with experience of caring for critically ill patients with serious SARS-CoV2 infection
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided imagery and FLASH techniqueFive 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 | Behavioural | Intervention |
Primary outcome
Feasibility 1 - Recruitment
Time frame: 1 month post-recruitment end date
Recruitment of at least 5 participants per month per site
Feasibility 2 - Protocol fidelity
Time frame: 1 month post-intervention final session
Adherence to >75% of protocol interventions
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.
Feasibility 4 - Participant retention
Time frame: 6 months post-intervention
Participant retention to study completion
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.
7 secondary outcomes
Mental wellbeing
Time frame: Baseline, 6 months post-intervention
Post-traumatic stress disorder
Time frame: Baseline, 6 months post-intervention
Anxiety
Time frame: Baseline, 6 months post-intervention
Depression
Time frame: Baseline, 6 months post-intervention
Quality of life EQ-5D-5L
Time frame: Baseline, 6 months post-intervention
Resilience
Time frame: Baseline, 6 months post-intervention
Burnout syndrome
Time frame: Baseline, 6 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Golding contact
Andy Bates principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery and FLASH technique in people with Psychological and Burnout, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Bates (02381206317, a.bates@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility 1 - Recruitment (time frame: 1 month post-recruitment end date). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.