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

NCT05591625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-12-28

No results posted yet for this study

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

Interventions

BEHAVIORAL

Eye Movement Desensitisation and Reprocessing

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.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-02-29
Completion
2025-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591625 on ClinicalTrials.gov