A Multi-centre, Randomised, Pilot Feasibility Study to Compare the Effectiveness of Eye-movement Desensitisation and Reprocessing Versus Usual Care in the Psychological Recovery of Intensive Care Survivors

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness. Participants will: * be recruited at hospital discharge * undergo a psychological assessment at 2-3 months post-hospital discharge * Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR * Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm. * All participants will repeat the psychological assessment 12-months after hospital discharge. Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months. The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Survivors of an intensive care admission, who have received level 3 care for \>24 hours.

• Aged ≥18 years

• Capacity to provide informed consent and complete trial interventions and assessments.

Locations
Other Locations
United Kingdom
University Hospitals Dorset
ACTIVE_NOT_RECRUITING
Poole
University Hospital Southampton
RECRUITING
Southampton
Contact Information
Primary
Andrew Bates
emerald@soton.ac.uk
023 8120 3170
Backup
Michael Grocott
023 8120 3170
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2025-02
Participants
Target number of participants: 160
Treatments
No_intervention: Control
Participants who exhibit symptoms of PTSD and are randomised to the control group, will receive usual care offered by their hospital.
Experimental: Eye Movement Desensitisation and Reprocessing
Participants who exhibit symptoms of PTSD and are randomised to the intervention group, will receive EMDR plus usual care offered by their hospital. EMDR will be delivered by trained and accredited psychological therapists, employed by National Health Service community mental health teams.
No_intervention: Observation
Participants who do not exhibit symptoms of PTSD will receive usual care offered by their hospital and repeat the psychological assessment at 12-months post-hospital discharge.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Southampton NHS Foundation Trust
Collaborators: National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov