SORA

Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND).

Cope, SR; Smith, JG; El-Leithy, S; Vanzan, S; Pentland, C; Pick, S; Golder, D; Hogwood, P; Turner, K; Billings, J; et al. Cope, SR; Smith, JG; El-Leithy, S; Vanzan, S; Pentland, C; Pick, S; Golder, D; Hogwood, P; Turner, K; Billings, J; Edwards, MJ (2023) MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for functional neurological disorder (FND). BMJ Open, 13 (6). e073727. ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2023-073727
SGUL Authors: Smith, Jared Grant

[img]
Preview
PDF Published Version
Available under License Creative Commons Attribution.

Download (2MB) | Preview

Abstract

INTRODUCTION: Functional neurological disorder (FND) refers to an involuntary loss of control over and/or aberrant perception of the body. Common presenting symptoms are functional (non-epileptic) seizures, and functional motor disorder, for example, walking difficulties, weakness or tremor. Greater access to effective treatments would lead to reduced distress and disability; and reduce unnecessary healthcare costs.This study will examine eye-movement desensitisation and reprocessing therapy (EMDR) as a treatment for FND. EMDR is an evidence-based treatment for post-traumatic stress disorder (PTSD), but its use for other conditions is growing. An FND-specific EMDR protocol will be tested, and if the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place. METHODS AND ANALYSIS: Fifty adult patients diagnosed with FND will be recruited. It will be a single-blind randomised controlled trial with two arms: EMDR (plus standard neuropsychiatric care; NPC) and standard NPC. The two groups will be compared at baseline (T0), 3 months (T1), 6 months (T2) and 9 months (T3). Measures of feasibility include safety, recruitment, retention, treatment adherence and acceptability. Clinical outcome measures will assess health-related functioning/quality of life, ratings of FND symptoms and severity, depression, anxiety, PTSD, dissociation, service utilisation and other costs. Improvement and satisfaction ratings will also be assessed. Feasibility outcomes will be summarised using descriptive statistics. Exploratory analyses using (linear/logistic) mixed-effect models will examine the rate of change in the groups' clinical outcome measures across the four time-points.After the intervention period, a sample of participants, and clinicians, will be invited to attend semistructured interviews. The interviews will be analysed using reflexive thematic analysis. ETHICS AND DISSEMINATION: This study has been approved by the NHS West Midlands-Edgbaston Research Ethics Committee. Study findings will be published in open access peer-reviewed journals, presented at conferences, and communicated to participants and other relevant stakeholders. TRIAL REGISTRATION: NCT05455450 (www. CLINICALTRIALS: gov).

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Keywords: adult psychiatry, clinical trials, neurology, Adult, Humans, Eye Movement Desensitization Reprocessing, Feasibility Studies, Quality of Life, Single-Blind Method, Stress Disorders, Post-Traumatic, Conversion Disorder, Treatment Outcome, Randomized Controlled Trials as Topic, Humans, Treatment Outcome, Feasibility Studies, Single-Blind Method, Stress Disorders, Post-Traumatic, Conversion Disorder, Quality of Life, Adult, Randomized Controlled Trials as Topic, Eye Movement Desensitization Reprocessing, neurology, adult psychiatry, clinical trials, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: BMJ Open
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
2 June 2023Published
26 April 2023Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
202277National Institute for Health and Care Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 37270188
Web of Science ID: WOS:001052254800093
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/115763
Publisher's version: https://doi.org/10.1136/bmjopen-2023-073727

Actions (login required)

Edit Item Edit Item