Clinical trial NCT05591625: Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Critical Illness
Eye Movement Desensitisation and Reprocessing
Depression, Anxiety
Keywords: EMDR
Feasibility
Acceptability
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2022-10-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with PTSD symptoms (2-3 months post-hospital discharge) will be assigned to either usual care or usual care plus EMDR.

Participants without PTSD symptoms (2-3 months post-hospital discharge) will enter an observation arm, which consists of a repeat psychological assessment at 12-months post-hospital discharge.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pre-existing cognitive impairment such as dementia
* Pre-existing diagnosis of psychosis
* Not expected to survive post-hospital discharge
* Traumatic brain injury

Primary outcomes:
measure: Recruitment, adherence, retention
timeFrame: 12-months
measure: Acceptability
timeFrame: 12-months
measure: Number of participants with adverse events (safety and tolerability)
timeFrame: 12-months
Secondary outcomes:
measure: Post-traumatic stress disorder
timeFrame: 12-months
measure: Clinician assessed Post-traumatic stress disorder
timeFrame: 12-months
measure: Sensitivity analysis
timeFrame: 12-months
measure: Anxiety
timeFrame: 12-months
measure: Depression
timeFrame: 12-months
measure: Health related quality of life
timeFrame: 12-months
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: 12-months
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: University Hospitals Dorset
state: Dorset
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
References: