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Multidisciplinary telehealth early intervention for patients with a recent diagnosis of functional neurological disorder (FND), with functional motor symptoms and/or functional dissociative seizures: the Epworth RESET-FND study

A randomised, controlled study assessing safety, feasibility of a structured multidisciplinary telehealth intervention program, compared to supportive therapies, for adult patients with the recent diagnosis of functional neurological disorder (FND), with functional motor symptoms and/or functional dissociative seizures: the Epworth RESET-FND study. The primary outcome is based on patient-reported global outcomes in individuals with FND.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001119381
Acronym
RESET-FND
Enrollment
60
Registered
2026-09-09
Start date
2026-10-02
Completion date
2027-10-02
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Functional Neurological Disorder (FND) is a condition in which people experience neurological symptoms, such as movement difficulties or seizures, that are related to changes in brain functioning rather than structural neurological disease. FND can significantly affect physical functioning, emotional wellbeing, quality of life, and day-to-day activities. The purpose of this research project is to evaluate a new multidisciplinary telehealth treatment program called RESET-FND. RESET-FND combines neuropsychological therapy and physiotherapy delivered by telehealth by clinicians experienced in the management of FND. This study aims to determine whether the RESET-FND program improves symptoms, physical functioning, psychosocial wellbeing, and quality of life compared with a supportive therapy control intervention. As a randomised study, patients are randomly allocated to one of two study groups: The RESET-FND intervention group, or a supportive therapy control group. to assess the potential benefits of this REST-FND intervention as assessed over 12 months.

Interventions

RESET-FND has been developed as a brief multidisciplinary telehealth early intervention program delivered over six weeks, integrating neuropsychological therapy and physiotherapy for individuals recently diagnosed with functional neurological disorder, specifically those with functional dissociative seizures and/or functional motor symptoms. The intervention is designed to support early engagement, symptom understanding, movement retraining, and development of self-management strategies through

RESET-FND has been developed as a brief multidisciplinary telehealth early intervention program delivered over six weeks, integrating neuropsychological therapy and physiotherapy for individuals recently diagnosed with functional neurological disorder, specifically those with functional dissociative seizures and/or functional motor symptoms. The intervention is designed to support early engagement, symptom understanding, movement retraining, and development of self-management strategies through a structured psycho-physical therapy program delivered by clinicians experienced in FND management. This is a single-site, single-blinded, two-arm pilot randomised controlled trial conducted at Epworth HealthCare. Participants with recently diagnosed FND, including functional motor symptoms and functional dissociative seizures, will be recruited and randomised to either the RESET-FND active intervention versus the control arm. Following screening, participants record symptom activity over a four-week baseline observation period, and those with persistent symptoms proceed to enrolment. Participants allocated to the intervention arm will undertake a six-week multidisciplinary telehealth program comprising neuropsychological therapy and physiotherapy delivered through structured individual videoconference sessions by neuropsychologists and physiotherapists experienced in the treatment of FND. The intervention incorporates psychoeducation, movement retraining, cognitive and behavioural strategies, graded exposure approaches, self-management planning, and home-based exercises, delivered according to a standardised therapy manual. Sessions are delivered separately by each discipline in weeks 1, 2 and 5 (60 minutes neuropsychology and 60 minutes physiotherapy per week), with weeks 3 and 4 reserved for consolidation and independent practice. The final session in week 6 is a combined 120-minute session delivered jointly by the neuropsychologist and physiotherapist. Participants therefore receive four hours of neuropsychology and four hours of physiotherapy, totalling eight hours of contact time. All of the sessions, except for the final session (combined 60mins with both neuropsychology and physiotherapy present together) will be offered separately; 60mins of neuropsychological therapy, 60min of physiotherapy. All participants will complete baseline assessments and follow-up assessments at 3 and 6 months following baseline. Outcome assessors will remain blinded throughout the study. During the therapy engagement period, no experimental medications or invasive procedures will be introduced, and participation will not alter routine clinical care outside the study intervention. Adherence, reminders and monitoring will be overseen by the research coordinator. Outcome measures include patient-reported global impression of improvement (primary), symptom burden, seizure frequency, motor symptom severity, anxiety, depression, quality of life, psychosocial functioning, healthcare utilisation, and the safety and feasibility of the intervention. In interventions in detail include: 1. Psychoeducation: This element will explain the mechanism of functional symptoms in line with current neurobiological understanding of FND (i.e., symptoms are thought to arise from altered functioning of brain networks governing movement, sensation and awareness, rather than from structural damage or disease, and are shaped by factors including attention, expectation, arousal and prior experience). Participants will be taken through how their diagnosis was reached, including the positive clinical signs identified in their own assessment, and the distinction between FND and structural neurological disease. The emphasis is on the reversibility of symptoms, the rationale for a combined psycho-physical approach, and the participant's role as an active agent in recovery. Education will include the utilisation of well-established analogies, metaphors and examples to explain these concepts to the patients and help us work through a biopsychosocial model of illness development, utilising a four P framework (pre-existing, precipitating, perpetuating and protective factors). 2. Movement retraining: This will include movement training starting from components of movement that are simple, becoming gradually more complex such as sit to stand, standing weight shifting, moving to stepping on spot, then towards building up walking in graded components.? 3. Cognitive and behavioural strategies: These skills will focus on identifying and reframing threat-based appraisals and unhelpful beliefs about symptoms (for example, the belief that symptoms signal harm or damage) alongside identification of unhelpful thinking styles and symptom-focused rumination. Behavioural strategies will address avoidance and safety behaviours, activity pacing, and values-based re-engagement with meaningful activity, supported by emotional awareness and arousal-regulation techniques such as breathing and grounding. Barriers to change will be formulated in the later sessions using the F.E.A.R. framework (fusion with unhelpful thoughts, unrealistic expectations, avoidance of discomfort, remoteness from values). 4. Graded exposure approaches: Building on the education components that target a reduction in fear of symptom provocation, participants will be encouraged to lean into discomfort in a graded way. A hierarchy of avoided activities will be developed collaboratively, with each item rated for anticipated distress and symptom provocation and ordered from least to most challenging. Participants will begin with a low to moderate-difficulty item, practise it repeatedly between sessions, with progress recorded in the activity diary. Once participants notice an improvement in their capacity to complete and tolerate the activity, they will be encouraged to progress. Examples include remaining at home alone or using public transport for participants with functional dissociative seizures, and walking outdoors, graded reduction in gait-aid use, or sustained standing tasks for those with functional motor symptoms. Psychology and physiotherapy hierarchies will be aligned so both target the same activity.? 5. Self-management planning: This may include utilising strategies in sessions that have been helpful in an independent way to manage symptom interference. An example of this may be using a standing postural exercise to reduce functional weakness in a lower limb, to regain motor control. These strategies turn into independent self-management strategies that can be utilised outside of telehealth session. 6. Home-based exercises: These may include movement retraining exercises into a formalised home exercise program; such as sit to stand, step training, walking practise with diverted attention. General lower limb strength and balance exercises such as squats, heel raises, balance exercises may also be provided for reconditioning. The intervention is manualised in structure and tailored in delivery. All participants receive the same number, sequence and duration of sessions, and the same content modules in the same order, as specified in the RESET-FND therapy manual. This standardisation is what is evaluated for feasibility and fidelity. Individualised elements as follows: What. Goals, graded exposure hierarchy, home exercise prescription and movement-retraining tasks, and behavioural strategies. Tasks are selected for each participant from a pre-determined list of suitable strategies in the manual, with content emphasis determined by symptoms/symptom subtype (e.g., seizures only vs gait disturbance only vs combined symptom profile etc). Why. FND is heterogeneous in subtype, baseline function, and avoidance profile. As such, an identical exercise prescription, exposure hierarchy, or symptom reduction techniques would be clinically inappropriate and, for movement-based telehealth activities, unsafe. When. At sessions 1–2 (goal setting, exercise prescription, exposure hierarchy), reviewed and progressed at sessions 4–6, and consolidated into the written self-management plan in the final combined session. How. Guided by the baseline face-to-face physiotherapy assessment and baseline psychological assessment, together with the participant's nominated goals and avoided activities. All tailoring occurs within parameters specified in the manual, with fidelity monitored through review of recorded sessions. Session attendance, non-attendance, and partial completion will be recorded in REDCap by the treating clinician after each session, verified against automated Microsoft Teams attendance and duration records. Participants in both arms will complete a weekly REDCap diary across the full six-week intervention period, including weeks 3 and 4, when no sessions are scheduled. In the intervention arm, this will record which strategies have been implemented, home exercise completion and progress towards nominated goals. The control arm diary will record equivalent activity and symptom information without intervention-specific content. Continuation of the diary through the consolidation break allows adherence to self-directed practice to be captured during the period of independent self-management. Automated REDCap reminders will be issued and adherence monitored by the research coordinator, with adherence and retention reviewed at four-weekly study monitoring meetings. Clinician fidelity to the therapy manual will be assessed separately through structured review of a stratified 10% sample of recorded sessions, including confirmation that control sessions exclude active therapeutic ingredients.

Sponsors

Epworth Medical Foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

18 years of age and above. Diagnosis of FND with motor symptoms or clinical established or documented diagnosis of FDS as per ILAE guidelines made by a neurologist within three months, regardless of symptom duration. Minimum of two seizure-like events in the past four weeks for those with FDS. Persistent symptoms after a four-week post-recruitment baseline observation period. Ability to provide informed consent. Computer/tablet access with a reliable internet connection. Valid email address. Basic computer literacy/competency. English proficiency at a level that allows provision of written informed consent, questionnaire engagement, and undertaking consent.

Exclusion criteria

Diagnosis of active comorbid epilepsy (1 or more epileptic seizures in the past 12 months). Severe neurocognitive disorder that precludes the ability to give informed consent and impacts the ability to undertake self-guided treatment (e.g., dementia, moderate–severe intellectual disability). Impaired vision or audition or insufficient English that would prevent partaking in the intervention. Active, clinically significant symptoms of a psychotic disorder or mood disorder that would interfere with therapy participation. Substance use disorder other than nicotine. Clinically significant suicide risk identified during screening. Participants will be excluded if they meet any of the following criteria on the Columbia-Suicide Severity Rating Scale (C-SSRS): Intensity of suicidal ideation score =4 within the month preceding assessment; Intensity of suicidal ideation score of 5 within the six months preceding assessment; or Any suicidal behaviour (including suicide attempts or preparatory acts) within the three months preceding assessment. Participants may also be excluded where, in the clinical judgement of the study investigator(s), their suicide risk would preclude safe participation, irrespective of C-SSRS score. Participants with non-suicidal self-injurious behaviour may be eligible following review and approval by the study investigator(s). Any medical or psychiatric symptoms that would interfere with therapy participation, as determined by the study investigator(s).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026