Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission

NCT05591625 | Unknown

• 1 other identifier: RHM CRI0424
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Traumatic Stress Disorder; Critical Illness; Eye Movement Desensitisation and Reprocessing; Depression, Anxiety

Keywords

EMDR; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12-months

Secondary Outcomes (7)

• Post-traumatic stress disorder

  12-months

• Clinician assessed Post-traumatic stress disorder

  12-months

• Sensitivity analysis

  12-months

• Anxiety

  12-months

• Depression

  12-months

Study Arms (3)

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.

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.

Interventions

Eye Movement Desensitisation and Reprocessing BEHAVIORAL

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.

Also known as: EMDR

Eye Movement Desensitisation and Reprocessing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

University Hospitals Dorset

Poole, Dorset, United Kingdom

ACTIVE NOT RECRUITING

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Related Publications (1)

• Bates 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.

  PMID: 38286705 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Critical Illness; Depression; Anxiety Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Andrew Bates

CONTACT

023 8120 3170; emerald@soton.ac.uk

Michael Grocott

CONTACT

023 8120 3170

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 24, 2022
• Study Start: February 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)