RecruitingACTRN12622000262707

A study to evaluate a brief internet-based intervention for patients with newly diagnosed functional seizures.

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.


Sponsor

Alfred Health

Enrollment

111 participants

Start Date

Mar 21, 2022

Study Type

Interventional

Conditions

Summary

The objective of this study is to investigate the effect of an internet-based self-help intervention program on seizure frequency for individuals with functional seizures. The first aim of this project is to develop an internet-based therapy for patients with functional seizures. To assess this new therapy, patients with a documented diagnosis of functional seizures will undertake a 5-week e-intervention, called re-PROGRAM, either guided by a therapist or on their own, followed by standard care. A third group of participants will receive standard care, which involves an appointment with a psychiatrist every 6 weeks. A goal of the research is to find out whether undertaking re-PROGRAM is more effective than standard care, and whether undertaking re-PROGRAM while guided by a therapist provides any further benefit to patients than engaging with the program with limited therapist contact. The second aim of this project is to assess the cognitive function and behavioural characteristics in patients with functional seizures and to identify predictors for successful treatment outcomes. Establishing why some people respond to treatment better than others will assist in developing more tailored therapy approaches and provide a better understanding of patients’ therapy experiences.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Functional seizures look like epileptic seizures but are not caused by abnormal electrical activity in the brain. Instead, they are linked to how the nervous system processes stress, trauma, and emotions. They can be just as disabling as epilepsy and are often difficult to treat. Many patients have limited access to effective therapies. This study is testing an online self-help program called re-PROGRAM, designed specifically for people newly diagnosed with functional seizures. The 5-week program teaches patients about their condition and offers strategies to reduce seizure frequency. Some participants will use the program with therapist guidance, some independently, and a third group will receive standard psychiatric care. The study also aims to understand why some people respond better to treatment than others by assessing thinking patterns and brain function. You may be eligible if you are 18 or older, have a confirmed functional seizure diagnosis from a video epilepsy monitoring unit, experience at least four typical seizures per month, have internet access, and are eligible for Medicare. People with active epilepsy, severe psychiatric conditions like psychosis or bipolar disorder, substance use disorder, or who are at immediate risk of self-harm are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 delive

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.


Locations(1)

The Alfred - Melbourne

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000262707


Related Trials