Post Traumatic Stress DisorderEMERALDNCT05591625
Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission
A study testing Eye Movement Desensitisation and Reprocessing in people with Post Traumatic Stress Disorder and Critical Illness, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Critical Illness, Eye Movement Desensitisation and Reprocessing
- What is being tested?
- Eye Movement Desensitisation and Reprocessing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Feb 2023to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing cognitive impairment such as dementia
- Pre-existing diagnosis of psychosis
- Not expected to survive post-hospital discharge
- Traumatic brain injury
Trial locations and contacts
2 sites in 1 country.
Michael Grocott contact
United Kingdom2 sites, 1 recruiting
- Active, not recruiting
University Hospitals Dorset
Poole, Dorset
- Recruiting
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
Rebecca Cusack, rebecca.cusack@uhs.nhs.uk
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Critical Illness, Eye Movement Desensitisation and Reprocessing, Depression, Anxiety
- Being tested
- Eye Movement Desensitisation and Reprocessing
- Keywords
- EMDR, Feasibility, Acceptability
- Medical subject headings
- Stress Disorders, Post-Traumatic, Critical Illness, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitisation and ReprocessingBehavioural
Also called EMDR
EMDR is a trauma-focussed, psychological talking therapy whereby the participant verbally relates a narrative of an emotionally disturbing memory, in brief sequential doses, while simultaneously focusing on an external stimulus, most commonly side-to-side finger movements of the psychological therapist. EMDR aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR is widely practiced, so is scalable. It is also protocolised, so can be taught and tested, and allows for fidelity assessment in controlled studies.
The number of sessions will depend on ongoing presence of disturbing memories. This will be determined by the psychological therapist and participant.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants who exhibit symptoms of PTSD and are randomised to the control group, will receive usual care offered by their hospital. |
| Eye Movement Desensitisation and Reprocessing | Experimental | 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. Receives: Behavioral: Eye Movement Desensitisation and Reprocessing |
| Observation | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment, adherence, retention
To determine whether investigating the use of EMDR for traumatised survivors of critical care can reach predefined feasibility objectives:
- Recruitment rate part A - we anticipate an average recruitment of 10 patients per month across the three participating sites. This is well above the median recruitment of 0.95 participants recruited per site per month, reported in a review of trials listed in the NIHR journals library (1997-2020)(31).
- Consent rate - number of patients recruited, expressed as a percentage of patients approached. Based on our previous work we expect this to be greater than 30%(28).
- Adherence will be determined by completion of ≥75% of planned EMDR sessions completed.
- Retention will be determined by ≥75% of participants completing the study follow-up assessment.
Measured: 12-months
Acceptability
To explore acceptability of participating in a Randomised Controlled Trail of EMDR for critical care survivors, psychology clinicians and research staff. Reported according to the Theoretical Framework of Acceptability. This qualitative methodology, using semi-structured interviews, provides a framework for assessing conceptually different constructs of acceptability in clinical trials; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
Measured: 12-months
Number of participants with adverse events (safety and tolerability)
Safety will be determined by assignment of causality of serious events. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility.
Measured: 12-months
Secondary outcomes (7)
Post-traumatic stress disorder
Change in post-traumatic stress disorder (PTSD) symptom severity using the Impact of Events Scale-Revised. (IES-R) The IES-R is a 22-question, patient reported outcome measure widely used to assess symptoms of PTSD, including in critical care research, and is recommended by critical care core outcome dataset developers and the International Conference of Harmonisation of Outcome Measures. The questions cover symptoms of intrusion, avoidance and hyperarousal. Participants indicate how distressing the symptoms have been over the last 7 days. Symptom severity can be 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit), 4 (extremely), giving a total scoring range of 0 to 88, with higher scores indicating more severe symptoms.
Measured: 12-months
Clinician assessed Post-traumatic stress disorder
To determine changes in symptoms of PTSD, participants will undergo the Clinician administered PTSD scale (CAPS-5) assessment at 2- and 12-months post-hospital discharge.
CAPS-5 is a 30-question structured interview, exploring severity and duration of PTSD symptoms, index trauma, subjective distress and impact on social and occupational functioning. Each question refers to PTSD symptoms and can be rated; 0=absent; 1=mild/sub-threshold; 2=moderate/threshold; 3=severe/markedly elevated; 4=extreme/incapacitating.
Scores from questions 1-20 will be combined to give an overall severity ranging, with high scores reflecting worse symptoms. In addition, the investigators will sum individual symptoms relating to symptom clusters from the Diagnostic and Statistical Manual of mental disorder; (5th Ed)
Measured: 12-months
Sensitivity analysis
To determine whether PTSD symptom severity and diagnoses, identified by patent reported Impact of Events Scale-Revised, correspond with those identified by Clinician administered PTSD Scale-5.
Measured: 12-months
Anxiety
Generalised Anxiety Disorder-7 (GAD-7): this 7-question, self-administered tool is validated to assess for anxiety symptom severity. Scores are calculated by assigning 0 for 'not at all, 1- 'several days', 2 - 'more than half the days' or 3 - 'nearly every day' for responses to nine questions, giving a score in the range 0-21. GAD-7 scores of 5, 10 and 15 represent cut-offs for mild, moderate and severe anxiety respectively.
Measured: 12-months
Depression
Patient Health Questionnaire-9 (PHQ-9): this self-administered, validated tool assesses depressive symptom severity. Scores are calculated by assigning 0 for 'not at all, 1- 'several days', 2 - 'more than half the days' or 3 - 'nearly every day' for responses to nine questions, giving a score in the range 0-27. PHQ-9 score of 0-4 demonstrates no - minimal depression severity. 5-9 = mild severity, 10-14 = moderate severity, 15-19 = moderately severe, 20-27 = severe.
Measured: 12-months
Health related quality of life
EuroQol Five Dimension- Five level scale (EQ5D -5L): comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants report levels ranging from 'no problems' to 'extreme problems'.
Measured: 12-months
Clinical Global Impression of Improvement (CGI-I)
The Clinical Global Impression of improvement can be used to assess symptom severity and response to treatment. It requires a clinician to rate the severity of a patient's mental illness, relative to other patients that the clinician has seen, who have the same diagnosis. The 7-point scale ranges from; 1 - normal, not at all ill, 2 - borderline mentally ill, 3 - mildly ill, 4 - moderately ill, 5 - markedly ill, 6 - severely ill, 7 - among the most extremely ill patients.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start20 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591625
- Sponsor's protocol ID
- RHM CRI0424
- Acronym
- EMERALD
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers should contact the Chief Investigator. The decision to share Individual Participant Data will be determined on a case-by-case basis.
Publications
Bates A, Cusack R, Golding H, Moyses H, Southam H, Rushbrook S, Highfield J, Pattison N, Baldwin DS, Grocott MPW. Eye movement desensitisation and reprocessing for post-traumatic stress in survivors of critical illness (EMERALD): a mixed-methods, randomised, single-blind, parallel group-controlled, feasibility trial. EClinicalMedicine. 2026 Jul 13;97:104082. doi: 10.1016/j.eclinm.2026.104082. eCollection 2026 Jul.
PubMed 42518933Bates A, Golding H, Rushbrook S, Highfield J, Pattison N, Baldwin D, Grocott MPW, Cusack R. Mixed-methods randomised study exploring the feasibility and acceptability of eye-movement desensitisation and reprocessing for improving the mental health of traumatised survivors of intensive care following hospital discharge: protocol. BMJ Open. 2024 Jan 29;14(1):e081969. doi: 10.1136/bmjopen-2023-081969.
PubMed 38286705
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05591625
- Acronym / sponsor ID
- EMERALD / RHM CRI0424
- Conditions
- Post Traumatic Stress Disorder, Critical Illness, Eye Movement Desensitisation and Reprocessing, Depression, Anxiety
- Keywords
- EMDR, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Oct 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants who exhibit symptoms of PTSD and are randomised to the control group, will receive usual care offered by their hospital. |
| Eye Movement Desensitisation and Reprocessing | Experimental | Behavioral: Eye Movement Desensitisation and ReprocessingParticipants 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. |
| Observation | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Pre-existing cognitive impairment such as dementia
- Pre-existing diagnosis of psychosis
- Not expected to survive post-hospital discharge
- Traumatic brain injury
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 |
|---|---|---|
| Eye Movement Desensitisation and ReprocessingAlso: EMDREMDR is a trauma-focussed, psychological talking therapy whereby the participant verbally relates a narrative of an emotionally disturbing memory, in brief sequential doses, while simultaneously focusing on an external stimulus, most commonly side-to-side finger movements of the psychological therapist. EMDR aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR is widely practiced, so is scalable. It is also protocolised, so can be taught and tested, and allows for fidelity assessment in controlled studies. The number of sessions will depend on ongoing presence of disturbing memories. This will be determined by the psychological therapist and participant. | Behavioural | Eye Movement Desensitisation and Reprocessing |
Primary outcome
Recruitment, adherence, retention
Time frame: 12-months
To determine whether investigating the use of EMDR for traumatised survivors of critical care can reach predefined feasibility objectives: * Recruitment rate part A - we anticipate an average recruitment of 10 patients per month across the three participating sites. This is well above the median recruitment of 0.95 participants recruited per site per month, reported in a review of trials listed in the NIHR journals library (1997-2020)(31). * Consent rate - number of patients recruited, expressed as a percentage of patients approached. Based on our previous work we expect this to be greater than 30%(28). * Adherence will be determined by completion of ≥75% of planned EMDR sessions completed. * Retention will be determined by ≥75% of participants completing the study follow-up assessment.
Acceptability
Time frame: 12-months
To explore acceptability of participating in a Randomised Controlled Trail of EMDR for critical care survivors, psychology clinicians and research staff. Reported according to the Theoretical Framework of Acceptability. This qualitative methodology, using semi-structured interviews, provides a framework for assessing conceptually different constructs of acceptability in clinical trials; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
Number of participants with adverse events (safety and tolerability)
Time frame: 12-months
Safety will be determined by assignment of causality of serious events. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility.
7 secondary outcomes
Post-traumatic stress disorder
Time frame: 12-months
Clinician assessed Post-traumatic stress disorder
Time frame: 12-months
Sensitivity analysis
Time frame: 12-months
Anxiety
Time frame: 12-months
Depression
Time frame: 12-months
Health related quality of life
Time frame: 12-months
Clinical Global Impression of Improvement (CGI-I)
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 42518933Bates A, Cusack R, Golding H, Moyses H, Southam H, Rushbrook S, Highfield J, Pattison N, Baldwin DS, Grocott MPW. Eye movement desensitisation and reprocessing for post-traumatic stress in survivors of critical illness (EMERALD): a mixed-methods, randomised, single-blind, parallel group-controlled, feasibility trial. EClinicalMedicine. 2026 Jul 13;97:104082. doi: 10.1016/j.eclinm.2026.104082. eCollection 2026 Jul.
- Derived from this study: PubMed 38286705Bates A, Golding H, Rushbrook S, Highfield J, Pattison N, Baldwin D, Grocott MPW, Cusack R. Mixed-methods randomised study exploring the feasibility and acceptability of eye-movement desensitisation and reprocessing for improving the mental health of traumatised survivors of intensive care following hospital discharge: protocol. BMJ Open. 2024 Jan 29;14(1):e081969. doi: 10.1136/bmjopen-2023-081969.
- Individual participant dataSharing planned: No. Researchers should contact the Chief Investigator. The decision to share Individual Participant Data will be determined on a case-by-case basis.
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Michael Grocott contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitisation and Reprocessing in people with Post Traumatic Stress Disorder and Critical Illness, run by University Hospital Southampton NHS Foundation Trust at 2 sites 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 3 inclusion and 4 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 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Andrew Bates (023 8120 3170, emerald@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment, adherence, retention (time frame: 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591625, which also lists 2 linked publications.
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 28 Dec 2023.