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

NCT05087186 | Unknown

• 1 other identifier: CRI0412
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological; Burnout; Post Traumatic Stress Disorder; Anxiety; Depression

Keywords

Critical Care; Intensive Care; Staff Wellbeing; Guided Imagery; FLASH technique

Outcome Measures

Primary Outcomes (5)

• Feasibility 1 - Recruitment

  Recruitment of at least 5 participants per month per site

  1 month post-recruitment end date

• Feasibility 2 - Protocol fidelity

  Adherence to \>75% of protocol interventions

  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.

  6 months post-intervention

• Feasibility 4 - Participant retention

  Participant retention to study completion

  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.

  Between 6 and 12 months post-intervention

Secondary Outcomes (7)

• Mental wellbeing

  Baseline, 6 months post-intervention

• Post-traumatic stress disorder

  Baseline, 6 months post-intervention

• Anxiety

  Baseline, 6 months post-intervention

• Depression

  Baseline, 6 months post-intervention

• Quality of life EQ-5D-5L

  Baseline, 6 months post-intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Group sessions with psychological therapists

Behavioral: Guided imagery and FLASH technique

Interventions

Guided imagery and FLASH technique 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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care nursing staff with experience of caring for critically ill patients with serious SARS-CoV2 infection

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andy Bates

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Bates

CONTACT

02381206317; a.bates@soton.ac.uk

Hannah Golding

CONTACT

hannah.golding@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 21, 2021
• Study Start: January 13, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

GB (1)