Protocol MODIFI: protocol for randomised feasibility study of eye-movement desensitisation and reprocessing therapy (EMDR) for [FND] 2023 Cope, Edwards et al

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).

Open access, https://bmjopen.bmj.com/content/13/6/e073727

 

"Exclusion criteria

...

Predominant diagnosis of chronic fatigue syndrome (comorbid diagnosis is acceptable, as long as FND is the predominant difficulty)."

 

£247,562 of taxpayer money granted to the investigators by the NIHR, yet again. https://fundingawards.nihr.ac.uk/award/NIHR202277

 

The eye movement part of EMDR gives the strong impression of being merely a theatrical placebo.

 

From Wikipedia,

"Eye movement desensitization and reprocessing (EMDR) is a form of psychotherapy devised by Francine Shapiro in the 1980s that was originally designed to alleviate the distress associated with traumatic memories such as post-traumatic stress disorder (PTSD). EMDR involves focusing on traumatic memories in a manner similar to exposure therapy while engaging in side-to-side eye movements. These eye movements have been criticized as having no scientific basis.[1] The founder promoted the therapy for the treatment of PTSD and proponents employed untestable hypotheses to explain negative results in controlled studies.[2] EMDR has been characterized as a pseudoscientific purple hat therapy (i.e. only as effective as its underlying therapeutic methods without any contribution from its distinctive add-ons).[3]

EMDR is recommended for the treatment of PTSD by various government and medical bodies citing varying levels of evidence, including the World Health Organization, the UK National Institute for Health and Care Excellence, the Australian National Health and Medical Research Council, and the US Departments of Veteran Affairs and Defense. The US National Institute of Medicine found insufficient evidence to recommend it as of 2008. Treatment guidelines note EMDR effectiveness is statistically the same as trauma-focused behavioral therapy, and the Australian National Health and Medical Research Council notes that this may be due to including most of the core elements of CBT."

https://en.wikipedia.org/wiki/Eye_movement_desensitization_and_reprocessing

 

A ‘no treatment’ control, misleadingly described as ‘care as usual’ is not a meaningful control. The analogy would be controlling a drug trial with ‘care as usual’ that is no placebo tablet designed to mimic the target drug without the active ingredient.

A genuine control would require a therapeutic intervention equal in time commitment to the EMDR component. Why is it that psycho-behavioural researchers believe that their interventions don’t require the same scientific rigour as drug trials? It would be simple enough to get the control subjects to do a flower arranging course or a music appreciation class, you could even call them brain retraining exercises.

 

Has anyone seen this EMDR study by Knoop?

https://www.emdria.org/resource/eye...on-persistent-negative-evaluation-of-fatigue/

 

"eye-movement desensitisation and reprocessing therapy"

How do they prevent the default response which would be unconstrained upward eye movements?

 

This sounds much more prone to bias than what they used in the CODES trial which was seizure frequency.

 

It’s just CBT with some quackery on top.

 

It doesn't appear to be indexed on PubMed, which is probably why I did not pick up on it when it was published.

This is it on the journal page, https://connect.springerpub.com/content/sgremdr/early/2023/06/26/emdr-2022-0060 - on my screen, to read the abstract, you need to click on the very small "Focus" button on the right hand side, underneath the access options.

 

Careful Andy, it could be a trap. Forcing you to hold your eyes to the right while being exposed to this paper's title could have powerful transdiagnostic effects...