Background:
Patients who survive a period of critical illness have a disproportionately high chance of
suffering from disturbing and persistent downstream psychological morbidity. These are
associated with reduced quality of life and increased healthcare utilisation.
A recent survey of United Kingdom follow-up services reported a lack of post-discharge
psychological support. There have been calls for collaborative efforts, between ICU and
mental health professionals, exploring whether established trauma-focussed treatment
modalities, may be tested for the benefit of ICU survivors.
Eye-Movement Desensitisation and Reprocessing (EMDR) has improved mental health in combat
veterans and victims of man-made and natural disasters. Small studies have also shown it to
be effective in healthcare settings, within the Emergency department, following cancer
diagnosis and implantation of cardioverter defibrillators. EMDR is recommended by United
Kingdom National Institute for Health and Care Excellence, World Health Organisation and the
Institute for Traumatic Stress Studies, for treating adult onset PTSD.
The investigators hypothesise that post-intensive care psychological health will be improved
by EMDR. Reports of it's application in this cohort have largely adopted a case study
approach. EMDR has never been systematically evaluated for effect in intensive care
survivors.
The investigator's recently completed feasibility study (NCT04455360) (In press; Journal of
the Intensive Care Society) informed design refinements for this study. Prior to conducting a
large scale study of clinical effectiveness, it is important to answer remaining
uncertainties, regarding feasibility, acceptability and to identify potential adaptations to
trial design.
Aims:
To evaluate whether it is feasible and acceptable to investigate EMDR, for intensive
care survivors in a clinical trial.
To inform refinements to the design of a fully-powered randomised controlled trial (RCT)
of clinical effectiveness.
To determine preliminary clinical effect of EMDR on PTSD symptoms of traumatised
survivors of intensive care admission.
Method:
A mixed methods, multi-centre, fully-randomised controlled, patient preference, pilot
feasibility study.
Patients will be recruited from University Hospital Southampton ICU, Royal Bournemouth
Hospital ICU, Poole General Hospital ICU and Queen Alexandra Hospital ICU, Portsmouth in the
United Kingdom.
All participants will enter a common pathway, watch and wait study, between Part A consent
and the 2-month post-hospital discharge assessment.
Part A: Watch and wait consent Hospital research staff will screen all patients within the
ICU. Patients who fulfil inclusion criteria but have none of the exclusion criteria will be
approached to discuss trial participation. The patient will be given the Patient Information
Sheet (PIS) and adequate time to consider participation according to Good Clinical Practice
guidelines. Capacity to consent must be determined in accordance to the Mental Capacity Act
2005.
Two month psychometric assessment All participants who granted Part A consent, to the 'watch
and wait' study will be invited to undertake screening for PTSD symptoms using the Impact of
Events Scale-Revised (IES-R). This patient-rated outcome measure can be completed
electronically by following a link sent via email. Alternatively, paper versions can be
posted, with a stamped addressed return envelope included.
Participants with a total IES-R score ≥22, indicative of symptoms of post-traumatic stress,
will be invited to consider consenting to an RCT of EMDR vs usual care.
Non-symptomatic participants (IES-R≤21) and those who are unwilling or unable to participate
in the RCT, will be asked to continue in the observation study, by completing the 12-month
psychometric assessment.
Part B: RCT consent The study team will telephone participants, who score ≥22 on the 2-month
PTSD screen, and ask them to consider consenting to the RCT of EMDR vs usual care. The RCT
participant information sheet (PIS) and informed consent form (ICF) will be available
electronically or via post. Participants consenting to the RCT will be asked to undertake a
Clinical Administered PTSD Scale for Diagnostic Statistical Manual-5 (CAPS-5) assessment of
PTSD symptoms and a Clinical Global Impression of Illness Severity (CGI-S). In addition, the
research team will ask participants to rate which arm of the study they would prefer, using a
Likert scale of 0-10.
Following this assessment, the study team will ask participants, with symptoms of
post-traumatic stress, to consider entering an RCT of EMDR vs usual care. (Part B consent)
Participants who are not displaying symptoms of post-traumatic stress will be asked to enter
an observation arm, and repeat the assessment, 12-months post-hospital discharge.
Participants who consent to Part B of the study will be randomised 1:1 to either usual care
or usual care plus EMDR with their local National health Service Psychological service.
All participants will repeat the 12-month assessment.
The investigators will conduct a qualitative process evaluation to capture contextual and
cultural factors not adequately determined by a purely quantitative study.
If feasibility and acceptability are established, information from this study will inform the
design of a subsequent, fully-powered Randomised Controlled Trial, to determine whether EMDR
is an effective treatment option for post-intensive care psychological health.