Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001119381p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
9/09/2026
Date last updated
Help: Date last updated
9/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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.
Additional trial identifiers [1] 317893 0
nil
Universal Trial Number (UTN)
Trial acronym
RESET-FND
Related trial records

Health condition
Health condition(s) studied:
Functional Neurological Disorder (FND) 342840 0
Neurological disorders 342841 0
Epilepsy 342842 0
Movement disorders 342843 0
Mental health 342844 0
Condition category
Condition code
Neurological 338954 338954 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 338955 338955 0 0
Physiotherapy
Mental Health 338956 338956 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 334738 0
Rehabilitation
Intervention code [2] 334739 0
Behaviour
Description of the comparator or control
Participants in the control arm will receive supportive 2x1-hr supportive talk therapy sessions via telehealth in weeks 1, 2, 5 & 6. This intervention will be delivered by the same psychologists delivering the intervention arm to control for therapist-specific effects. To ensure treatment differentiation, the control arm will receive a manualised supportive control intervention. This protocol permits the use of common therapeutic factors, including active listening, empathetic validation, and time-based attention, to maintain ethical standards and participant engagement. However, it strictly prohibits active therapeutic ingredients specific to the experimental arm, such as cognitive restructuring, behavioural modification, or clinical advice-giving. Adherence to these boundaries will be monitored through fidelity checks of recorded sessions to ensure the control remains technically inert while remaining a credible placebo.
Adherence, reminders and monitoring of attendance to the sessions will be overseen by the senior research coordinator.
Control group
Active

Outcomes
Primary outcome [1] 346192 0
The patients perceived changes in symptoms, functionality and mental health, that have occurred following the intervention, will be assessed.
Timepoint [1] 346192 0
The treatment and control interventions will be undertaken over 6 weeks. Assessments will be made at end of the interventions, then at 3 and 6 months following the interventions to assess longer term outcomes
Secondary outcome [1] 464947 0
health related quality of life
Timepoint [1] 464947 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [2] 464948 0
anxiety
Timepoint [2] 464948 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [3] 464949 0
depression
Timepoint [3] 464949 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [4] 464950 0
social functioning
Timepoint [4] 464950 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [5] 464951 0
Functional motor disorders
Timepoint [5] 464951 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [6] 464952 0
Seizures
Timepoint [6] 464952 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [7] 464953 0
gait speed
Timepoint [7] 464953 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [8] 464954 0
Healthcare Utilisation
Timepoint [8] 464954 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [9] 466565 0
lower limb strength and balance
Timepoint [9] 466565 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [10] 466566 0
functional mobility
Timepoint [10] 466566 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions
Secondary outcome [11] 467629 0
gait endurance
Timepoint [11] 467629 0
These assessments will be made prior to the commencement of the interventions, at the completion of the 6 weeks of the interventions, then 3 and 6 months post completion of the interventions

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random sequence, computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
descriptive statistics will be utilised to assess effectiveness and feasibility and acceptance of the interventions. This is an exploratory pilot study of a new interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2026
Actual
Date of last participant enrolment
Anticipated
2/10/2027
Actual
Date of last data collection
Anticipated
2/10/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29832 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 46183 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 322433 0
Charities/Societies/Foundations
Name [1] 322433 0
Epworth Medical Foundation
Country [1] 322433 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Epworth Medical Foundation
Address
Country
Australia
Secondary sponsor category [1] 325357 0
Hospital
Name [1] 325357 0
Epworth Eastern Private Hospital
Address [1] 325357 0
Country [1] 325357 0
Australia
Other collaborator category [1] 284035 0
Hospital
Name [1] 284035 0
Epworth Camberwell
Address [1] 284035 0
Country [1] 284035 0
Australia
Other collaborator category [2] 284036 0
Other
Name [2] 284036 0
Epilepsy Network Australia
Address [2] 284036 0
Country [2] 284036 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320926 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 320926 0
Ethics committee country [1] 320926 0
Australia
Date submitted for ethics approval [1] 320926 0
22/07/2026
Approval date [1] 320926 0
Ethics approval number [1] 320926 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152098 0
A/Prof Amanda Gilligan
Address 152098 0
Epworth Eastern Private Hospital, 1 Arnold St, Box Hill. Victoria. 3128
Country 152098 0
Australia
Phone 152098 0
+61 3 88077105
Fax 152098 0
Email 152098 0
[email protected]
Contact person for public queries
Name 152099 0
Amanda Gilligan
Address 152099 0
Epworth Eastern Private Hospital, 1 Arnold St, Box Hill. Victoria 3128
Country 152099 0
Australia
Phone 152099 0
+61 3 88077105
Fax 152099 0
Email 152099 0
[email protected]
Contact person for scientific queries
Name 152100 0
Amanda Gilligan
Address 152100 0
Epworth Eastern Private Hospital, 1 Arnold St, Box Hill. Victoria 3128
Country 152100 0
Australia
Phone 152100 0
+61 3 88077105
Fax 152100 0
Email 152100 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.