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Trial registered on ANZCTR


Registration number
ACTRN12622000262707
Ethics application status
Approved
Date submitted
20/11/2021
Date registered
14/02/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate a brief internet-based intervention for patients with newly diagnosed functional seizures.
Scientific title
Content or context? A three-parallel arm randomised controlled trial to evaluate a brief internet-based intervention on seizure frequency for patients with newly diagnosed functional seizures.
Secondary ID [1] 305836 0
Nil known
Universal Trial Number (UTN)
U1111-1271-7715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Seizures 324370 0
Condition category
Condition code
Neurological 321856 321856 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Re-PROGRAM is a 5-week structured skills-based program designed to enhance participants’ knowledge of functional seizures and expose them to seizure-controlling strategies. It is designed to be delivered with or without assistance from a therapist and is based on a framework of cognitive behavioural therapy (CBT). It has been designed specifically for this study.

Arm 1:
re-PROGRAM synchronous therapy arm. A psychologist will interact with the participant via videoconferencing in a weekly individual one-hour session across five consecutive weeks. The psychologist with minimum 2 years’ experience will use a standardised therapy manual, specifically designed for this study, conceptualised and piloted for safety, feasibility, and acceptability. Following intervention completion, participants will attend a half hour appointment with a psychiatrist with minimum 3 years’ experience in the functional seizures clinic approximately every six weeks until 12 months post baseline.

Arm 2:
Unguided re-PROGRAM arm. Access to the internet intervention across five consecutive weeks. Asynchronous psychologist support will take part individually. Participants will be provided with a recommended timetable of weekly module completion and instructions detailing how to contact a psychologist with minimum 2 years’ experience within the platform regarding technical difficulties. They will receive 10 mins per week of psychologist-client contact in the form of email correspondence. In general, the role of the psychologist in this arm is to ensure participants progress through the e-intervention and complete activities and homework on time. The psychologist will be permitted to give feedback on homework, answer questions (providing reference to the program when necessary), encourage progress, provide support and validation, and handle scheduling issues. The psychologist will answer questions within 24 hrs. Following intervention completion, participants will attend a half hour appointment with a psychiatrist with minimum 3 years’ experience in the functional seizures clinic approximately every six weeks until 12 months post baseline.

In Arm 1 and Arm 2 for the subsequent appointments with psychiatry, medical care will be identical to the control group i.e., will include support, consideration of psychiatric comorbidities and any associated drug treatment and general review of participant health, but CBT techniques or reinforcement of the strategies and tools learnt during the intervention will not be discussed. Subsequent treatment will be delivered as per our usual clinical practice, i.e., in person if conditions permit and if patient is able, otherwise, via Telehealth. Adherence to the internet self-guided intervention will be monitored through online website data logs and weekly email confirmation. Attendance records will be kept to monitor adherence to the therapist-guided intervention.
Intervention code [1] 322237 0
Treatment: Other
Comparator / control treatment
Control group (arm 3): Participants in the standard care arm (control group) will attend a half hour appointment via the internet every six weeks until 12 months post baseline, with a psychiatrist with minimum 3 years’ experience in the functional seizures outpatient clinic. Medical care by psychiatrists will include support, consideration of psychiatric comorbidities and any associated drug treatment and general review but CBT techniques for functional seizures will not be discussed. These appointments are a routine component of standard medical care.
Control group
Active

Outcomes
Primary outcome [1] 329623 0
Monthly seizure frequency. A continuous variable that comprises a count of seizures over a four-week period. Patients will be provided with an electronic seizure diary via RedCap and asked to record seizure activity. Data will be collected every 4 weeks. The seizure diary was designed specifically for this study.
Timepoint [1] 329623 0
6 weeks, 6 months, and 12 months compared to baseline.
Secondary outcome [1] 403202 0
Psychosocial functioning: Measured by the Work and Social Adjustment Scale (WSAS).. Five-item scale measuring patients' own perceptions of the impact of functional seizures on their functioning in terms of work, home management, social leisure and private leisure activities, family and other relationships.
Timepoint [1] 403202 0
6 weeks, 6 months, and 12 months compared to baseline.
Secondary outcome [2] 404991 0
Healthcare resource utilisation: Measured via the adapted self-report Client Service Receipt Inventory (CSRI). Includes hospital attendances and admissions, GP contacts, informal care, lost work time and financial benefits.
Timepoint [2] 404991 0
6 weeks, 6 months, and 12 months compared to baseline.
Secondary outcome [3] 404992 0
Physical symptoms: Measured by the Patient Health Questionnaire (PHQ-15) for somatic symptom severity,
Timepoint [3] 404992 0
6 weeks, 6 months, and 12 months compared to baseline.
Secondary outcome [4] 404994 0
Life impact: Measured by the SF-12v2 Short Form Health Survey. Measures health related quality of life from the patient's point of view.
Timepoint [4] 404994 0
6 weeks, 6 months, and 12 months compared to baseline.
Secondary outcome [5] 406056 0
Anxiety: Measured by the General Anxiety Disorder [GAD-7] for anxiety
Timepoint [5] 406056 0
6 weeks, 6 months, & 12 months compared to baseline
Secondary outcome [6] 406057 0
Depression: Measured by the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), a 6-item scale for depression that has been used in functional seizure studies.
Timepoint [6] 406057 0
6 weeks, 6 months, & 12 months compared to baseline

Eligibility
Key inclusion criteria
Documented diagnosis of functional seizures following admission to the video epilepsy monitoring (VEM) unit; be aged 18 years or over; have access to a computer or tablet with reliable internet connection; a valid email address; basic computer literacy/competency; English proficiency at a level that allows provision of written informed consent, completion of cognitive tests, questionnaire engagement and undertaking the intervention consent; be eligible for Medicare; and exceed the cut-off score of at least four typical functional seizures per month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of active comorbid epilepsy; a severe neurocognitive disorder that precludes the ability to give informed consent and impacts cognition (e.g. dementia, moderate-severe intellectual disability); impaired vision or audition that would prevent them from perceiving test materials necessary for cognitive assessment; insufficient English that would confound the cognitive assessment; severe comorbid psychiatric disorders (i.e. bipolar disorder, psychotic disorders); comorbid substance use disorder other than nicotine; active elevated risk of self-harm or suicide requiring urgent clinical management; or a medical condition that would interfere with therapy participation.

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)
Following consent, participants will be assigned a unique study number and randomised into the study arms using block randomisation by a person independent of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated within REDcap’s electronic casereport form (eCRF; subject to entry of key data into the eCRF).
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
Statistical methods / analysis
As the study is assessing a clinical population, recruitment of participants with functional seizures is dependent on the number of VEM hospital admissions. It is estimated that between two and four patients per month will be recruited at The Alfred functional seizure outpatient clinic following referral from VEM at The Alfred Hospital.

Statistical power analysis was performed for sample size estimation, based on data from the CODES trial (Goldstein et al., 2020), which used a comparable study design (N = 368), comparing treatment outcome between two study arms. The effect size in this study was 0.36, considered to be medium using Cohen's (1988) criteria. For a more conservative estimate of sample size using a Cohen’s f of 0.20, an alpha = .05 and power = 0.80, the projected sample size needed with this effect size (GPower 3.1) is approximately N = 78 for this simplest between group comparison of three study arms. Due to the well-documented high attrition rate of up to 25% in this patient population, our proposed sample size of 98+ (33+ per group) will be more than adequate for the main objective of this study. To allow for additional objectives of conducting subgroup analysis, a power analysis using a Cohen’s f of 0.30, alpha = .05 and power 0.80, the projected sample size is approximately N = 111 to detect a moderate effect (37+ per group).

Statistical analyses will be dependent on the final sample size and determined in consultation with a statistician. Seizure counts will be modelled using Poisson regression. Continuity-adjusted ?2 will be used to compare treatment groups on baseline categorical variables. Between-group differences in continuous variables will be evaluated using Analysis of variance (ANOVA). Analysis of covariance will be used to estimate within-group changes on continuous secondary outcomes. Exploratory analysis will also be undertaken due to the novel nature of the research.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/02/2022
Actual
21/03/2022
Date of last participant enrolment
Anticipated
24/05/2024
Actual
Date of last data collection
Anticipated
24/05/2025
Actual
Sample size
Target
111
Accrual to date
108
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21136 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 35997 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 310192 0
Hospital
Name [1] 310192 0
Alfred SPF (Epilepsy and Neuropharmacology Clinical Trails Fund)
Country [1] 310192 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 311739 0
None
Name [1] 311739 0
Address [1] 311739 0
Country [1] 311739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309873 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 309873 0
Ethics committee country [1] 309873 0
Australia
Date submitted for ethics approval [1] 309873 0
27/07/2021
Approval date [1] 309873 0
05/11/2021
Ethics approval number [1] 309873 0

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

Contacts
Principal investigator
Name 115686 0
Dr Tobias Winton-Brown
Address 115686 0
Monash University
Wellington Road
Clayton VIC 3800
Country 115686 0
Australia
Phone 115686 0
+61 3 9076 0863
Fax 115686 0
Email 115686 0
tobias.winton-brown@monash.edu
Contact person for public queries
Name 115687 0
Tobias Winton-Brown
Address 115687 0
Monash University
Wellington Road
Clayton VIC 3800
Country 115687 0
Australia
Phone 115687 0
+61 3 9076 0863
Fax 115687 0
Email 115687 0
tobias.winton-brown@monash.edu
Contact person for scientific queries
Name 115688 0
Tobias Winton-Brown
Address 115688 0
Monash University
Wellington Road
Clayton VIC 3800
Country 115688 0
Australia
Phone 115688 0
+61 3 90760863
Fax 115688 0
Email 115688 0
toby.winton-brown@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14171Ethical approval  tobias.winton-brown@monash.edu
14172Study protocol  tobias.winton-brown@monash.edu



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseContent or context? A study protocol for a three-arm parallel randomised controlled trial of R e -PROGRAM, a brief internet-based intervention for patients with functional seizures.2023https://dx.doi.org/10.1136/bmjopen-2023-072835
N.B. These documents automatically identified may not have been verified by the study sponsor.