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Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND) (MODIFI)

Primary Purpose

Functional Neurological Symptom Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Eye movement desensitisation and reprocessing therapy
Neuropsychiatric care
Sponsored by
South West London and St George's Mental Health NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Functional Neurological Symptom Disorder focused on measuring Functional neurological disorder, FND

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Predominant diagnosis of functional seizures and/or functional motor disorder, with diagnosis confirmed by neurologist
  2. Aged 18 years or over
  3. Capacity to consent
  4. Willingness to attend regular psychological therapy sessions
  5. Reporting at least 1 traumatic event on the International Trauma Exposure Measure

Exclusion Criteria:

  1. Non-English speaking
  2. Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation
  3. Predominant diagnosis of Borderline Personality Disorder*
  4. Predominant diagnosis of chronic pain condition*, e.g. fibromyalgia
  5. Predominant diagnosis of chronic fatigue syndrome*
  6. Diagnosis of a psychotic disorder
  7. Diagnosis of Dissociative Identity Disorder or score in clinical range on "identity disturbance" subscale of Multiscale Dissociation inventory
  8. Uncontrolled epileptic seizures
  9. Diagnosis of an eating disorder
  10. Current severe self harm or strong suicidal ideation that requires secondary care mental health services input
  11. Current alcohol or drug harmful-use or dependence
  12. Current diazepam use exceeding the equivalent of 10mg per day
  13. Currently attending individual psychological therapy focused on functional neurological disorder or other specialist functional neurological disorder-specific treatment such as inpatient/outpatient multi-disciplinary treatment or intensive functional neurological disorder-specific physiotherapy

    • Comorbid diagnosis is acceptable, as long as functional neurological disorder is the predominant difficulty

Sites / Locations

  • Neuropsychiatry Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EMDR + NPC

Neuropsychiatric Care (NPC)

Arm Description

8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care.

Standard medical care

Outcomes

Primary Outcome Measures

Recruitment rate
Percentage of potentially eligible participants attending screening interview
Intervention adherence
Percentage of participants randomised to EMDR+NPC who complete therapy
Outcome measures completion
Percentage of participants who complete outcome measures at all 4 time points

Secondary Outcome Measures

EQ-5D-5L
Brief health questionnaire
Ecological Momentary Assessment (EMA) of FND symptoms
Using an App, FND symptoms will be rated in terms of frequency, severity, interference with daily functioning, associated distress and preoccupation with
PHQ-9
Self-rated measure of depression
GAD-7
Self-rated measure of anxiety
International Trauma Questionnaire (ITQ)
Measure of PTSD and Complex PTSD
Multiscale Dissociation Inventory
Measure of dissociation
Adult Service Use Schedule (AD-SUS)
Self-report measure of service use
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Health-Related Quality of life/functioning measure

Full Information

First Posted
June 14, 2022
Last Updated
May 16, 2023
Sponsor
South West London and St George's Mental Health NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05455450
Brief Title
Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND)
Acronym
MODIFI
Official Title
Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South West London and St George's Mental Health NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Functional Neurological Disorder (FND) is a problem with the functioning of the nervous system and how the brain and body send and receive signals, rather than due to neurological disease or injury. This causes a range of neurological symptoms such as seizures, shaking, weakness, and paralysis. The symptoms are associated with significant distress and disability. Treatment for FND in the United Kingdom is limited, and the evidence-base for treatment is poor, despite it being a common presentation. A psychological therapy called cognitive-behavioural therapy has been found to be beneficial, but it does not help everyone. EMDR is an effective treatment for posttraumatic stress disorder, but it can also be helpful with other conditions. There is a small amount of case study evidence that EMDR can be useful at treating FND, but proper scientific evaluation is needed. This research aims to evaluate the possibility of delivering, and potential benefit, of EMDR for FND. If the study shows that it is feasible and potentially beneficial, a larger trial will be designed. The study will recruit 50 participants who have specific functional neurological symptoms: weakness, walking difficulties, jerks, shaking, and/or seizures from a Neuropsychiatry Service. Participants will be allocated to EMDR, and routine medical appointments, or routine medical appointments alone. Allocation will be carried out by a computer programme. Those allocated to EMDR will be offered 8-16 weekly therapy sessions, completed within 6 months, and follow-up session 1 month after therapy has ended. Participants will be able to choose whether to attend therapy in-person or via an online video conferencing platform. Participants will complete questionnaires regarding health-related functioning, FND, mental health, and healthcare utilisation. These questionnaires will be completed at the beginning, 3 months, 6 months, and 9 months. Some participants will attend interviews about experiences of treatment.
Detailed Description
Background: 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, e.g. walking difficulties, weakness, or tremor. Treatment in the United Kingdom is inconsistently available, and there is inequity of care compared to other neurological conditions. There are no established standards of care for this patient group. FND is associated with large health- and social-care costs. Greater access to effective treatments would lead to reduced distress and disability for patients with FND; and reduce unnecessary costs to the NHS. This research proposes using 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. A FND-specific EMDR protocol will be developed and tested, and if the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place. Aims and Objectives: I. Test the acceptability and feasibility of an FND-specific EMDR intervention protocol, delivered physically or virtually. II. Investigate the value of a range of outcome measures, to determine the outcome measure with greatest symptom improvement and the required sample size, for a substantive RCT. III. Carry out semi-structured interviews with participants and therapists to explore experiences of EMDR and the trial; informing the intervention and design for a substantive trial. Methods: 50 adult patients with a diagnosis of FND will be recruited via a Neuropsychiatry Service. The study will be a single-blind randomised controlled trial (RCT) 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, and treatment adherence and acceptability. Clinical outcome measures assess health-related functioning/quality of life, FND, depression, anxiety, PTSD, dissociation, service-utilisation and other costs. Patient-rated improvement and satisfaction 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 intervention and control groups' clinical outcome measures across the four time-points. After the intervention period, a sample of participants, and clinicians, will be invited to attend semi-structured interviews on trial experiences. The interviews will be analysed using reflexive thematic analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Symptom Disorder
Keywords
Functional neurological disorder, FND

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be randomised into EMDR (plus neuropsychiatric care; NPC) or NPC. A stratified block randomisation will be used to ensure similar numbers of patients with predominant functional seizures or functional motor disorder, and PTSD/non-PTSD are relatively equal across arms.
Masking
Outcomes Assessor
Masking Description
The assessing RA and project statistician will be blind to treatment allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMDR + NPC
Arm Type
Experimental
Arm Description
8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care.
Arm Title
Neuropsychiatric Care (NPC)
Arm Type
Other
Arm Description
Standard medical care
Intervention Type
Other
Intervention Name(s)
Eye movement desensitisation and reprocessing therapy
Other Intervention Name(s)
EMDR
Intervention Description
Up to 16 EMDR sessions (minimum of 8 sessions), and 1-month follow-up session, as well as attending neuropsychiatric appointments (NPC). Participants will be given the choice of attending EMDR physically face-to-face or virtually via a video-consultation platform. Sessions will normally be attended weekly, with treatment completed within 6 months. Sessions will be 60-90 minutes long. EMDR will follow the standard 8-phase protocol, with additions so that it is tailored for FND presentations. The FND-specific EMDR therapy protocol has been developed for the trial by the chief investigator.
Intervention Type
Other
Intervention Name(s)
Neuropsychiatric care
Intervention Description
Standard medical care consisting of 1-3 30 minute appointments with neuropsychiatrist over the course of the 9-month trial period.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Percentage of potentially eligible participants attending screening interview
Time Frame
12 months (recruitment stage)
Title
Intervention adherence
Description
Percentage of participants randomised to EMDR+NPC who complete therapy
Time Frame
18 months (intervention stage)
Title
Outcome measures completion
Description
Percentage of participants who complete outcome measures at all 4 time points
Time Frame
12 months (9-month follow-up stage)
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
Brief health questionnaire
Time Frame
4 time points over 9 months (trial period)
Title
Ecological Momentary Assessment (EMA) of FND symptoms
Description
Using an App, FND symptoms will be rated in terms of frequency, severity, interference with daily functioning, associated distress and preoccupation with
Time Frame
4 time points over 9 months (trial period)
Title
PHQ-9
Description
Self-rated measure of depression
Time Frame
4 time points over 9 months (trial period)
Title
GAD-7
Description
Self-rated measure of anxiety
Time Frame
4 time points over 9 months (trial period)
Title
International Trauma Questionnaire (ITQ)
Description
Measure of PTSD and Complex PTSD
Time Frame
4 time points over 9 months (trial period)
Title
Multiscale Dissociation Inventory
Description
Measure of dissociation
Time Frame
4 time points over 9 months (trial period)
Title
Adult Service Use Schedule (AD-SUS)
Description
Self-report measure of service use
Time Frame
2 time points over 9 months (trial period)
Title
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Description
Health-Related Quality of life/functioning measure
Time Frame
4 time points over 9 months (trial period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Predominant diagnosis of functional seizures and/or functional motor disorder, with diagnosis confirmed by neurologist Aged 18 years or over Capacity to consent Willingness to attend regular psychological therapy sessions Reporting at least 1 traumatic event on the International Trauma Exposure Measure Exclusion Criteria: Non-English speaking Current ongoing adversity that is likely to interfere with psychological therapy, e.g. domestic violence, homelessness, unresolved compensation claim/litigation Predominant diagnosis of Borderline Personality Disorder* Predominant diagnosis of chronic pain condition*, e.g. fibromyalgia Predominant diagnosis of chronic fatigue syndrome* Diagnosis of a psychotic disorder Diagnosis of Dissociative Identity Disorder or score in clinical range on "identity disturbance" subscale of Multiscale Dissociation inventory Uncontrolled epileptic seizures Diagnosis of an eating disorder Current severe self harm or strong suicidal ideation that requires secondary care mental health services input Current alcohol or drug harmful-use or dependence Current diazepam use exceeding the equivalent of 10mg per day Currently attending individual psychological therapy focused on functional neurological disorder or other specialist functional neurological disorder-specific treatment such as inpatient/outpatient multi-disciplinary treatment or intensive functional neurological disorder-specific physiotherapy Comorbid diagnosis is acceptable, as long as functional neurological disorder is the predominant difficulty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah R Cope, DClinPsy
Organizational Affiliation
South West London & St. George's Mental Health NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychiatry Service
City
London
ZIP/Postal Code
SW170QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Eye MOvement DesensItisation and Reprocessing Therapy (EMDR) for FunctIonal Neurological Disorder (FND)

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