ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Neurological

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]

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]

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]